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FDA Simultaneous Marketing ANPRM

Bracketed Comment Letter Report

COMMENT NUMBER - 2005N-0345-EC1970

2005N-0345-EC1970 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Crousey, Joshua

2005N-0345-EC1970 - TEXT

Issue Areas/Comments

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?

<1: 3.2>No.</1: 3.2>

A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?

<2: 6.2, 6.5.4>No, as a law student I can say that there would be significant limitations. This would be regarded as creating a 'class' of people. This always has problems associated with it.</2: 6.2, 6.5.4>

B. If it could, would it be able to do so as practical matter and, if so, how?

<3: 7.5.3>Here's my biggest problem. If it's available easily, what's going to stop an older person from buying it when he finds out that he got an underage girl pregnant? Right now, we have the prescription process in place and serious consequences for trying to avoid using a prescription. This is a drug that we just might want people to have to get a prescription.

How would you be able to tell who should or shouldn't receive it? Are you going to check ids at the store? How can we be sure that older people won't give it to younger people?</3: 7.5.3>

COMMENT NUMBER - 2005N-0345-EC199

2005N-0345-EC199 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Gay, Sarah

2005N-0345-EC199 - TEXT

Maybe- see below.

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?

This is the same question as above, except with a typo.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<1: 1.2.1>There is significant confusion as to why FDA is making such a huge deal of its interpretation in this single case, which has such important ramifications for women, and whose drug has been demanded as OTC-available in the U.S. for years, by both doctors and the public. There is also confusion as to why the application for the combined status (Rx and OTC) was framed in terms of age in the first place, instead of requesting simply to make it OTC across the board. Did the applying agency craft its request in terms of age, based on FDA agency findings (such as those quoted below)?</1: 1.2.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<2: 5.5>Yes and No. If FDA Rules are based on scientific recommendations, rather than political pressure, the current application to make 'Plan B' available OTC to women 17 and over is consistent with the FDA Commissioner's own statement that 'The FDA?s drug center, the Center for Drug Evaluation and Research or CDER, completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an over the counter product, but only for women who are 17 years of age and older,' and the drug application should be approved. A rulemaking on the issue of general interpretation of section 503(b) is irrelevant in this case.</2: 5.5>

<3: 6.3.4>IF it's a medical concern, based on research, that age affects how the drug is received by the body, and that the drug will affect younger women differently BIOLOGICALLY AND MEDICALLY, the supporting science is there, and the drug should be allowed to go to market as proposed, based on earlier precedents establishing different medical indications and effects for such an allowance. If it is NOT a medically-based distinction, and sound scientific research (free from political framing) shows it is safe for any woman regardless of age, the drug's availability OTC for anyone should be approved as has been consistently recommended by FDA scientists, doctors worldwide, and by the public who wishes to exert control over their reproductive health.</3: 6.3.4>

<4: 6.3.5>As a matter of law, it's a moot point; if the FDA passes such a regulation, it is already law, no? Isn't the FDA granted law enforcement powers related to its regulations?</4: 6.3.5>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 6.6.3, 7.3.2>I don't know, that is a question for YOU to deal with! What does FDA enforce now? Why should it be any more difficult for the FDA to enforce this than any other prescription-only regulations?</5: 6.6.3, 7.3.2>

<6: 7.4.4>OK, you've got a supply available to the larger population OTC. Why couldn't, for example, age-i.d. requirements such as those governing sales of cigarettes and alcohol be enforced at the sales counter, and become the responsibility of general law-enforcement, while regulation of the prescription sales remains purvue of the FDA?</6: 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<7: 8.1>I frankly don't see why this is an issue. Yes.</7: 8.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<8: 9.2.2>None.</8: 9.2.2>

GENERAL

<9: 1.2.1, 2.1>The reversal of the FDA's promise to make a decision on this application by September, is disappointing in the least and quite frankly, a bit sickening. It appears quite political and is a sad state of affairs. Your statement of August 26, 2005 reads as a transparent stalling tactic, devoid of solid scientific foundation and based on thinly devised 'concerns for long-term policy implications.' I fear for the integrity of the agency. While genetic engineering has been introduced and encouraged by the FDA for major industry growth over the past ten years, with no assurance I know of that long-term implications are non-existent, I recall no such waffling on considerations about or calls for further research on it. We now have fish genes in our corn with no real knowledge of how this will affect our immune systems and gene pools over generations; yet you are so 'concerned' about the implications of a proven, safe way for women to take their own health and reproductive decisions into their own hands, you would limit that ability for another span of years. This behavior is inconsistent with an interest in the public health and is deplorable on the part of the FDA. I urge you to change your direction and allow the resolution that has been recommended by responsible scientists and experts for two years: get the drug to market and available over the counter, whether to those only over 17 or to all. You don't need the public's input on how to do that. That is your area of expertise. You already have the public's mandate that it be done.</9: 1.2.1, 2.1>

COMMENT NUMBER - 2005N-0345-EC2009

2005N-0345-EC2009 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Gibbons, Bridget

2005N-0345-EC2009 - TEXT

Issue Areas/Comments

<1: 3.1>Yes.</1: 3.1> <2: 3.8.1, 3.9.1>The FDA already does this for nicotine replacement drugs, and in the interest of legislative clarity, a clear rule should be established for drugs available in both prescription and OTC. This will finally allow the FDA to make a decision regarding Plan B, a decision consumers have waited on for years.</2: 3.8.1, 3.9.1>

<3: 3.1>Yes.</3: 3.1> <4: 3.8.1>Such a rule will clarify this rule for future drugs so that consumers will have easier access to drugs. As the pharmaceutical industry becomes more and more involved in the everyday lives of Americans, increasing ease and access will aid both industry and consumers in making the right drug choices free from the need for prescriptions for drugs determined to be safe for OTC by the FDA.</4: 3.8.1>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<5: 4.2>I disagree that there is confusion over this issue. </5: 4.2><6: 5.3.2>I believe that the confusion surrounding Plan B stems from religious and political disagreement with the drug itself. However, if a clarification of the rule will allow the FDA to finally make a decision regarding Plan B, I would approve of a rulemaking in order to facilitate decisionmaking.</6: 5.3.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<7: 5.3.2>As stated above, I think the "confusion" is merely a political smokescreen. However, future drugs may cause legitimate confusion, so perhaps it is in the best interest of the consumer population to have a bright-line rule regarding these drugs.</7: 5.3.2>

<8: 6.1>Absolutely.</8: 6.1> <9: 6.4.1>Although I personally disagree that there should be an age limit on access to Plan B, there are already age limitations on other drugs like Nicoderm and Nicorette.</9: 6.4.1> <10: 6.6.2>As a matter of public policy, it is up to the legislature to determine age limits, as the FDA commission has tried to do, despite interference from outside sources.</10: 6.6.2>

B. If it could, would it be able to do so as practical matter and, if so, how?

<11: 6.4.1, 7.4.4>The FDA already only allows nictoine drugs to be dispensed to those over 18. Adults present an ID to get their product. Any other drug could be enforced in the same manner.</11: 6.4.1, 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<12: 8.4.1, 9.1.1>Yes. There is no reason to make arbitrary distinctions in packaging as long as the content of the drug is the same. As long as the products are substantially the same product, with no difference in content or dosage, there is no reason to require different packaging.</12: 8.4.1, 9.1.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<13: 9.1.1>If the products differed in dosage or content, it would be inappropriate to sell them in a single package.</13: 9.1.1>

GENERAL

<14: 1.2, 2>The delay in approving Plan B is a political smokescreen. The deception on the part of certain staff members at the FDA goes against the agreement reached with Senators Clinton and Murray this past summer. Either approve or deny this product. Follow your own policy. Remain independent and act in the best interest of the population. Please. </14: 1.2, 2>

COMMENT NUMBER - 2005N-0345-EC201

2005N-0345-EC201 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Tuchinsky, Marla

2005N-0345-EC201 - TEXT

<1: 3.1, 3.8.3>To the extent that your interpretation is preventing women from getting access to a perfectly safe and effective drug, yes.</1: 3.1, 3.8.3>

<2: 6.6.3>1. You already do limit the use of certain drugs by age -- alcohol and tobacco are both age-regulated drugs. </2: 6.6.3>
<3: 6.6.1, 7.4.1>2. Drugstores routinely keep OTC products behind the counter (albeit usually to prevent theft).
3. Several states have imposed limits on purchasing Sudafed, for example. Clearly, this should not pose a stumbling block to releasing Plan B.</3: 6.6.1, 7.4.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

See my reply above.

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<4: 8.4.1>Why not, if the reason that one is prescription and the other not is based on the age of the patient and not the drug itself? As I understand it, the product isn't different.</4: 8.4.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<5: 9.1.1>If the dosage were different. If they were manufactured by different companies.</5: 9.1.1>

GENERAL

<6: 1.2.1>It seems against your core mission to keep a safe and effective pharmaceutical off the market. Denying women access to Plan B several years after it passed your scientific screens is inexplicable.</6: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC2022

2005N-0345-EC2022 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Munro, Margaret

2005N-0345-EC2022 - TEXT

<1: 3.2>No - the FDA should not initiate rulemaking.</1: 3.2>

<2: 3.2>No - the FDA should not initiate a rulemaking to codify its interpretation.</2: 3.2>

GENERAL

<3: 6.5.1, 6.6.2>It is not the FDA's job to create public policy, merely to judge on the safety and efficacy of pharmaceuticals, and to keep the food supply safe. Rulemaking may be effective in cases where dosages need to be monitored in order to keep a pharmaceutical safe and effective - beyond that question, the FDA should not be creating rules; if action is needed to keep a pharmaceutical from a certain group of people, let Congress create and pass that legislation, and let them bear the responsibility of their actions. </3: 6.5.1, 6.6.2>

COMMENT NUMBER - 2005N-0345-EC206

2005N-0345-EC206 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Levy, Gayle

2005N-0345-EC206 - TEXT

Issue Areas/Comments

<1: 3.2, 3.9.1>This same situation has worked for Claritin. It is now available OTC and by prescription. No other law making is necessary.</1: 3.2, 3.9.1>

Same answer as above.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1>It would seem so.</2: 4.1> <3: 4.3.4>Apparently when allergy medication is involved and not a political controversy, the FDA has no problem letting the medication go OTC. However, despite medical and health officials deeming Plan B safe, the FDA has a problem with interepretion for political gains.</3: 4.3.4>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.2>No. No amount of rulemaking (barring the overturn of Roe v. Wade) will change the politics involved.</4: 5.2>

<5: 6.1>Yes.</5: 6.1> <6: 6.6.3>The government does it for both cigarettes and alcohol. Are you planning to make both illegal to everyone because the age limitations cannot be 100% enforced?</6: 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<7: 7.1, 7.4.4>The same as they do for tobacco and alcohol. When someone comes to the register to buy that product they will be asked for proof of age. </7: 7.1, 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<8: 8.8>I'm not sure how Claritin does it. You could look to that as a model.</8: 8.8>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<9: 9.2.2>I can't think of any.</9: 9.2.2>

GENERAL

<10: 1.2.1>This product has been safely used all over the world. The medical and professional staff at the FDA have overwhelmingly approved it safe for OTC use in the US. There should be no reason why this should be stopped. </10: 1.2.1><11: 6.6.3, 7.4.4>The age concern can be alleviated the same way the government does it for buying tobacco and alcohol. The person buying the medication can be asked for age identification. </11: 6.6.3, 7.4.4><12: 2.1>Once Barr Labs proves it safe for those under 16 this should not be an issue at all.

One of the reasons that the US is a great country is that we have political and religious freedoms, however, these should not be intertwined. The thoughts of conservative Christians should not be ruling how the FDA approves it MEDICAL products. The MEDCIAL experts have deemed this product safe and that is the advice you should follow. Although the administration and the country seems to be following a conservative bent right now, the FDA does not need to bend to religious pressures. I am a scientist and am very dishartened that the FDA will not respect the views and opinions of their own medical and scientific staff.</12: 2.1>

COMMENT NUMBER - 2005N-0345-EC21

2005N-0345-EC21 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Richman, Bobbi

2005N-0345-EC21 - TEXT

Issue Areas/Comments

<1: 3.2>DEFINATELY NOT.</1: 3.2> <2: 1.2.3, 3.3>IF IT WERE SAFE ENOUGH FOR OTC SALES IT WOULDN'T NEED TO BE PRESCRIPTION. THE PUBLIC IS NOT KNOWLEDGEABLE ENOUGH TO KNOW WHEN DR. SUPERVISION IS NECESSARY OR NOT. </2: 1.2.3, 3.3><3: 1.2.3, 7.5.3>THERE COULD BE NO MORE CONTROL OVER WHO BUYS IT OTC THAN THERE IS FOR CIGARETTES OR LIQUOR. IF THERE IS AN AGE LIMIT, IT IS EASY TO HAVE SOMEONE ELSE PURCHASE IT FOR THE PERSON. NOT ALL STORES INFORCE THE AGE CRITERIA, NOR CAN THEY ADVISE CUSTOMERS WHETHER THEY SHOULD CONSULT A PHYSICIAN.</3: 1.2.3, 7.5.3>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<4: 4.3.4>IT IS THE MOST POORLY WRITTEN LETTER I HAVE READ. REDUNDANT, POORLY EXPLAINED WITH NO INFORMATION ABOUT PLAN B FOR THE READER. TOTALLY CONFUSING TO UNDERSTAND THE POINT BEING MADE</4: 4.3.4>

C. If so, would a rulemaking on this issue help dispet that confusion?

FIRST OF ALL WHOEVER WROTE THIS QUESTION "C" SHOULD HAVE PROOF READ IT. WHAT DOES DISPET MEAN? <5: 1.3, 5.4.2.2>IF YOU ARE ASKING THE PUBLICS OPINION, AND WE FEEL THERE IS CONFUSION, WHY DO YOU THINK IT WOULD BE ANY CLEARER IF YOU MAKE A DECISION YOURSELVES. WE ALL KNOW THE CORRUPTI0N IN THE FDA IN FAVOR OF MONEY MAKING DRUG COMPANIES SO WHY ASK OUR OPINION. YOU WILL DO WHAT YOU WANT ANYWAY. LOOK AT VIOX. NO MORE TO BE SAID AFTER THAT. </5: 1.3, 5.4.2.2>

COMMENT NUMBER - 2005N-0345-EC210

2005N-0345-EC210 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Felty, Amy

2005N-0345-EC210 - TEXT

Issue Areas/Comments

They could make it a law but I do not think they would be able to enforce it. <1: 7.5.3>At your local drug store, who would have the responsibility of enforcing such limitations? The pharmacists are occupied with their duties of providing the correct presciption medication and should not be required to additionally 'police' who is buying what OTC drug and how old they are. The workers at the registers should not be given the responsibility of contolling who buys what unless an entire system is set up as we do for the purchasing of alcohol.</1: 7.5.3> <2: 7.2>Therefore, no I do not think it could be enforced in a practical manner.</2: 7.2>

GENERAL

<3: 7.5.2, 7.5.3>As a quality assurance professional I would be concerned that it would not be practically feasable to have the appropriate controls in place to prevent abuse of some drugs if they were sold as both presciptions and OTC. Unless clinical studies covered things like misuse and over use of the drugs I would be concerned for the safety of the public. We have to remember that the majority of the public are not highly educated in the areas of science and would potentially not understand the negative affects of the active ingedients if not used exactly per the label indications. </3: 7.5.2, 7.5.3>

<4: 1.2.3>As a woman and a human being I am particlarlty concened with the effects of these presciption vs. OTC discussions as it pertains to the Plan B drug. When the word got out of this drug being sold OTC (provided that is what happened) I can forsee nothing but misuse of this drug by the majority of the population. Either it would be taken too frequently as a substitute for the birth control pill or it would be taken at incorrect times and could harm the development of a fetus.

Therefore, at this time I would disagree with making an active ingedient, used for the same indication, available for use by both presciption and OTC. </4: 1.2.3>

COMMENT NUMBER - 2005N-0345-EC2107

2005N-0345-EC2107 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Oyen, Duane

2005N-0345-EC2107 - TEXT

Issue Areas/Comments

<1: 3.1>Yes.</1: 3.1> <2: 3.9.1>Please explain the effective difference between, for example, OTC ibuprofen and Motrin 600 with regard to prescription enforcement. This is neither new nor "molecular biochemistry" (a subject specific "rocket science" metaphor) </2: 3.9.1>

<3: 2.1, 3.1>Yes- and in a realistic way, not as outlawing disguised as regulation. </3: 2.1, 3.1>

<4: 6.1, 6.6.3>Society does it all the time with substances that are legal but limited to adults- cigarettes and alcohol, for example; prescription items are easier to track than those products.</4: 6.1, 6.6.3> <5: 6.7, 7.4.5>The enforcement in a free society is imperfect, as is enforcement of any law in a free society, but there are balancing tests that can be applied- risk versus cost, probability of misuse, penalties for fraudulent acquisition and use, etc. that will mitigate the problem. </5: 6.7, 7.4.5>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.4.6, 7.6>The cutoff age should be 18, or 15 with parental approval- not 16. That means the parent buys and signs for it, not a minor under any circumstances. </6: 7.4.6, 7.6><7: 7.4.1, 7.4.5, 7.4.6>Over age 18, the person must ask at the pharmacy counter and sign a specific certification acknowledging that it is illegal to pass the compounds on to anyone else, and the signature is an oath not to do so, under significnat penalty of legal sanctions, including possible jail time. </7: 7.4.1, 7.4.5, 7.4.6>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<8: 8.2>The different products should not be sold in the same packaging. </8: 8.2><9: 8.6.4>There should be signficant alert notices on the OTC package and the rules regarding consumer eligibility shoud be broadly disseminated to enhance enforcement success. </9: 8.6.4>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

N/A

GENERAL

<10: 6.5.1>As with all liberty versus regulation issues, in a free country there should be a presumption that the public is not moronic, nor criminal, nor incapable of being responsible for his or her own life. There are a lot of places where things should be culturally discouraged but not outlawed- and morality is absolutely the first area to which that applies. We need the same campaigns against underage promiscuity that we have against smoking, but that is not a reason to play Big Brother to adults.

If the only criterion for illegality is the possibility that a drug might be improperly dispensed second-hand, we need to outlaw ALL pain medications, period. </10: 6.5.1>

<11: 6.5.4>But the parental rights to deal with minor children should not be curtailed under any circumstances. There is a point where the family has to trump the culture, and the law should enable that. </11: 6.5.4>

COMMENT NUMBER - 2005N-0345-EC211

2005N-0345-EC211 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Young, Stan

2005N-0345-EC211 - TEXT

Issue Areas/Comments

No.

<1: 3.2>No.</1: 3.2>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.2>No.</2: 4.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.2>No.</3: 5.2>

<4: 6.2, 6.5.3>No, this question has already been addressed in the case of parental notification laws, for example. They linger for a little while, then are tossed out at appeals court level.</4: 6.2, 6.5.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 7.2>No. </5: 7.2><6: 7.5.3>A teenage girl who feels the need for this medication will borrow an older sister's ID, or use her fake ID, or get an older friend to get it, or heaven forbid, shop lift it. Of course, a friendly pharmacist must might not ask the age question. And as an over the counter med for some, I'm sure some enterprising soul will set up a website and offer it over the internet.</6: 7.5.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

Moot point.

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

Moot point.

GENERAL

<7: 2.1, 3.8.7>As a conservative Republican, I'd note that the commissioners should not waste my money trying to go down this twisty path of logic. You'll trip yourselves up, and cost the government and the consumer money.</7: 2.1, 3.8.7> <8: 1.2.1>The women who feel the need for this product need it quickly, without jumping through regulatory hoops. It's not your job to protect their virginity - by definition, that's gone anyhow. Contraception is legal, abortion is legal. If this drug is reasonably safe and effective, approve it and get your noses out of these women's personal lives.

We're talking someone old enough to have sex, old enough to have a baby. I'd rather have a 12 year old buying and using this than having a 13 year old mother. Sticking your heads in the ground and saying "don't have sex" is too late by the time we're talking this drug.

Let's make this the least traumatic we can on all concerned. </8: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC212

2005N-0345-EC212 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kisly, Anne

2005N-0345-EC212 - TEXT

<1: 3.8.4>I think the text and examples provide clear examples of when a drug product may be marketed as both prescription and OTC. Examples should not be interpreted to mean that they cover all situations. They are after all, examples.</1: 3.8.4>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 3.8.5>The interpretation of it may be confusing because, as in the case in question, the safety data for levonorgestrel is different from the safety data in the examples and the past regulatory decisions. I would expect decisions regarding prescription(RX) and OTC access to be made on a case-by-case basis. Not all drugs will fit the examples provided. The regulatory interpretation of section 503(b) will never explicitly address all the different possible situations.</2: 3.8.5>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 3.8.5>I think a sentence could be added to clarify that decisions are made on a case-by-case basis. I doubt that any rule is hard and fast and will cover all submissions.</3: 3.8.5>

<4: 7.4.4>Someone would have to act in the role of the enforcer. In the case of the OTC availability of levonorgestrel, the pharmacist would have to check the consumer?s age by asking for personal identification. The pharmacist would have to assume the person, if of legal age, is buying it for herself or for someone who is of legal age. The assumption is the problem.</4: 7.4.4>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 7.5.3>No. I do not think it is practical. We know that minors have friends who are of legal age who buy restricted items for them. The situation with levonorgestrel is no different. Consider the motivation level of a young woman who does not want to handle an unwanted pregnancy. The motivation to acquire and take emergency contraception (EC) would be high. While a licensed medical practitioner could still prescribe and counsel the younger patient on the safe use of EC, I?m not convinced this is an absolute necessity. If there are data, from a randomized controlled study, that show a younger woman is at risk if her access to EC is not limited by prescription and she does not receive counseling, I would challenge the extrapolation of the findings from the sample of study participants in the study to the population at large. I expect a highly-motivated young woman would read and follow the instructions on an OTC product.</5: 7.5.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.3.4, 8.9>Do you mean the same products (not different in terms of strength, route of administration, indication, etc) or the same package? Is less information required on an RX package because someone assumes the licensed practitioner provides counseling, than an OTC package? The patient or consumer information, regarding dosing instructions and safety risks provided in the package, should be the same for a product available OTC or RX. An OTC package should list the following in large font size: (1) specific situations in which levonorgestrel should NOT be used; (2) the side effects to be expected; (3) information for special groups, possibly diabetics? The choice of words should be carefully selected, eg, side effects not adverse events, specific situations in which levonorgestrel should NOT be used, not contraindications.</6: 8.3.4, 8.9>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 9.1.1>This must be determined on a case-by-case basis. All possible scenarios can?t be foreseen. As soon as we agree, this circumstance or that circumstance requires different packages, another circumstance will arise to be an exception.</7: 9.1.1>

GENERAL

The following information can be read easier in the attachment, where my response in italics follows the FDA question or comment. The italic font doesn't show up below (at least not on this screen). I would appreciate acknowledgement that this was received.

<8: 8.9>The question we have been asked to address is whether Plan B should be available without a prescription on a pharmacy shelf, similar to the way other OTC medicines like some cough syrups and allergy pills are sold, for women age 16 and older, and remain prescription-only for those under the age of 16.

How severe are the side effects (nausea and vomiting) if taken incorrectly, enough to meet the criteria for a serious adverse event, or are they mild, transient events that occur in isolation (without other events)? Are the proposed dosing instructions in the package provided by the drug company clearly written, such that counseling by a licensed practitioner is not necessary?</8: 8.9>

<9: 1.2.1>Can age be used as a criterion on which we decide whether a drug should be prescription or OTC, as has been proposed in this case?

I would question if factors other than age comprise the real underlying basis for restricting access to a medication. In the case of EC, age, in and of itself, is not a valid criterion for ethical reasons. I don?t think the majority of women should have restricted access to EC, because a few women are at greater risk from of a lack of understanding dosing requirements, dosing limitations, lack of understanding the potential safety issues, etc.

In the case of levonorgestrel, the decision to restrict access by younger women sends a message to young women that they can?t read and understand instructions on a package that describes dosing instructions, safety warnings, etc. Limiting access to EC to younger women is not ethical and is discriminatory, because it assumes low intellectual abilities and poor judgment on the part of the younger women.

My 12-year-old son, with his 7th grade education, can walk into a store, buy, and take aspirin or Tylenol following the dosage chart on the bottle. </9: 1.2.1>

Am I supposed to be convinced that young women are less intelligent than he is in understanding how to take an OTC drug?

<10: 1.2.1>The FDA?s drug center, the Center for Drug Evaluation and Research or CDER, completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an over the counter product, but only for women who are 17 years of age and older.

The decision to restrict access by younger women sends a message to young women that they can?t read and understand instructions on a package that describes dosing instructions, safety warnings, etc.

I have a question for you. Is this really about concern for the safety of younger women, or is it about preventing legal problems if young women acquire the drug OTC, take the drug incorrectly, develop safety issues then sue the pharmaceutical company and accuse the FDA representatives of not doing their jobs? A prescription is no guarantee that the patient received the necessary counseling from the licensed practitioner on the specifics of how to use the medicine correctly, regardless of age. A prescription is no guarantee that the patient will be compliant, regardless of age.

I commend you on your extensive safety review. Please continue. Since when was Congress staffed by anyone who knows anything about evaluating the safety of drugs?</10: 1.2.1>

2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF

COMMENT NUMBER - 2005N-0345-EC213

2005N-0345-EC213 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Goggin, Terresa

2005N-0345-EC213 - TEXT

Issue Areas/Comments

<1: 3.2, 3.3.2, 3.8.4>No, I believe your previous guidelines are adequate. If it is safe without a practitioner's prescription then it should be available OTC.</1: 3.2, 3.3.2, 3.8.4>

See statement above.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.2, 4.4.2>I think the current guidelines are adequate and straightforward. Personal politics are what is clouding the availability of this drug, and probably others in the future if this precedent is allowed.</2: 4.2, 4.4.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

See statement B.

<3: 1.2.1, 6.5.4>OTC should not be limited; no more than we limit the sale of say aspirin, acetominaphin, ibuprofen, cough syrups, decongestants, etc. Risk warnings...absolutely! Limited access...absolutely not!</3: 1.2.1, 6.5.4>

B. If it could, would it be able to do so as practical matter and, if so, how?

<4: 6.6.3, 7.1, 7.4.4>Certainly by prescriptions for minors and "carding" everyone else, just like alcohol or cigarettes</4: 6.6.3, 7.1, 7.4.4>...<5: 1.2.1>but the age limitation should not exist...if sex occurs (consensual or non-consensual), even for a minor, quick access to the drug is essential to efficacy.</5: 1.2.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.1>Yes, but this is just administrative wrangling...complicating things by trying to "please" a certain political constituency.</6: 8.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 9.2.2>Under no circumstances would it be inappropriate; the drug is what it is...what is the point of making the package a different color to show that someone is underage...other than discriminating against them and singling them out for possible ridicule.</7: 9.2.2>

GENERAL

<8: 2.1>Let's get away from trying to satisfy a political base...the FDA was established to protect the health of all Americans, not just one particular constituency.</8: 2.1>

COMMENT NUMBER - 2005N-0345-EC216

2005N-0345-EC216 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ellis, Pamela

2005N-0345-EC216 - TEXT

Issue Areas/Comments

yes

<1: 3.1>yes</1: 3.1>

<2: 6.1>Yes</2: 6.1>. <3: 8.8>Similarly to the current requirement of the statement 'Federal law requires prescription for this medication' be printed on the Rx version and not on the OTC version. Although, psuedoephedrine has recently been restricted to 18 and over and behind-the-counter status and it underwent no package change whatsoever. Who is enforcing this limitation? This stall tactic is ridiculous in light of the fact that these situations already exist in todays market.</3: 8.8>

B. If it could, would it be able to do so as practical matter and, if so, how?

<4: 7.1>Yes.</4: 7.1> <5: 6.6.1, 7.4.3>State Departments of Health will inspect the process as it does all other processes.</5: 6.6.1, 7.4.3> <6: 6.6.3, 7.4.4>ID's will be checked for OTC product as with nicotine patches, alcohol, cigarettes, etc</6: 6.6.3, 7.4.4>...<7: 1.2.1>However, let me be clear and say that Plan B should be available OTC with NO age restriction. A bottle of Tylenol, which can be purchased by anyone, poses a far greater health threat if used incorrectly than Plan B ever would.</7: 1.2.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<8: 3.9.1>It is legal. For example, I currently have OTC Prilosec in my pharmacy AND a prescription-only omeprazole.</8: 3.9.1> <9: 8.6.4>Therefore, Plan B would require different packaging on the outside stating its Rx requirement for Rx version and not for the behind-the-counter version. The inside packaging would remain the same as 15 year-olds will take it the same way as 30 year-olds will. </9: 8.6.4><10: 2.1, 6.6.1>This is no reason for a delay to market. Incidently, pseudoephedrine products were just put behind-the-counter, at least in my state, with NO change in packaging. Perhaps if pregnancy affected everyone as does nasal congestion, years of delay and request for public comment would not be necessary.</10: 2.1, 6.6.1>

GENERAL

<11: 1.2.1, 3.3.3>Plan B is safe for use by women of ALL ages. It has been available OTC in over 38 other countries for years. The data is available on use in teenagers and adults and should have been consulted at the time of application. Withholding this incredibly effective and safe drug, the 2 requirements for OTC status, the FDA is doing a disservice to women and women's healthcare and destroying its reputation as a sound, scientific entity on which the American public can depend.</11: 1.2.1, 3.3.3> <12: 1.2.1, 2.1>It should be clear to all, regardless of beliefs or values, that the effects of taking Plan B is infinintely less damaging to the body than a pregnancy is. Especially when a 13 year-old is carrying to full term. When will women stopped being punished for their biology? Women must have all the options possible to control their reproduction. This product is one of the best to come along in some time. Stop bowing to right-wing political pressure and do the job the FDA was commissioned to do! Be scientists and let individuals decide their morality.</12: 1.2.1, 2.1>

COMMENT NUMBER - 2005N-0345-EC217

2005N-0345-EC217 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dietz, Ken

2005N-0345-EC217 - TEXT

GENERAL

<1: 1.2.1, 2.1>Your position on Plan B is clearly an attempt to delay approval of non-prescription sales for some unstated reason. Your stated reason is full of holes, and is clearly unsupportable. </1: 1.2.1, 2.1><2: 6.1, 6.6.3, 6.6.4>The government currently has regulations in place requiring age-limited availability for cigarettes, alcohol, firearms, pornography, and lotto tickets. But you can't establish a similar regulation for Plan B? </2: 6.1, 6.6.3, 6.6.4>

I smell a rat here.

COMMENT NUMBER - 2005N-0345-EC22

2005N-0345-EC22 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rankis, A

2005N-0345-EC22 - TEXT

Issue Areas/Comments

No, Current situation is fine

<1: 3.2>No, Current situation is fine</1: 3.2>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.2>No,</2: 4.2> Current situation is fine

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.2>No</3: 5.2>, Current situation is fine

<4: 6.2>No</4: 6.2>, the use of the product would be abused

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 7.2, 7.5.3>No, the use of the product would be abused</5: 7.2, 7.5.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.2>no</6: 8.2>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 9.2.2>none</7: 9.2.2>

GENERAL

<8: 7.5.3>If a drug is indeed for "emergency contraception", there appears no way to control or enforce it's use in emergencies only</8: 7.5.3>

COMMENT NUMBER - 2005N-0345-EC224

2005N-0345-EC224 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Roettcher, Phil

2005N-0345-EC224 - TEXT

<1: 1.2.1, 6.3.2>I see no reason why a single molecule cannot be sold in two different formats though I would prefer you follow the advice given by your medical staff that Plan B medications are safe for all women of child bearing age. </1: 1.2.1, 6.3.2><2: 6.6.3, 7.3.1.1>Over the counter is fine, but if you must compromise, treating it like tobacco, where there is a minimum age restriction would be fine. For those under the age, a prescription should be obtained and dispensed by a licensed Pharmacy.</2: 6.6.3, 7.3.1.1>

<3: 3.8.5>Decisions can be made on a case by case level.</3: 3.8.5><4: 1.2.1> In the case of Plan B medication, since the medication causes no harm by itself, it should be made widely available. Adult women should be allowed to make decisions for themselves.</4: 1.2.1>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<5: 4.2>only by the FDA who are more politically bound!</5: 4.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<6: 5.5>Advance with the technology and society. Change the rules to allow for multiple applications of the same molecule and let the market sort it out.</6: 5.5>

<7: 6.6.3>I don't really see enforcement as a legitimate issue for the FDA. The same folks who enforce marihuana and vitamin supplement laws can enforce any unusual rules here. Personally, I don't think there should be prescription restrictions here but if you must, enable the ATF to take on this task. Maybe they can rename themselves DAFT.</7: 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<8: 7.6>Does it really require law enforcement to make sure a young girl doesn't have an unwanted pregnancy? Time is important with this drug. Restrictions only hurt society over time.</8: 7.6>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<9: 8.1, 8.9>Yes, unquestionably. The only people that would complain would be the pharmacy who can mark up their product more than OTC.</9: 8.1, 8.9>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<10: 9.2.2>None</10: 9.2.2>!

GENERAL

<11: 1.2.1, 2.1>As VP Dick Cheney said last year, "Freedom means Freedom." This product has proven to be safe by all research and is not mind altering. Let women decide for themselves if they can stop an unwanted pregnancy. Government should step as far away from this as they do nutritional supplements. Make sure it is safe and effective for the public and let the public decide for themselves. If it is stupid, the knowing user bears the consequences herself. Don't let fear and ignorance trump freedom for people to make good and informed decisions for themselves. </11: 1.2.1, 2.1>

COMMENT NUMBER - 2005N-0345-EC226

2005N-0345-EC226 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Cepeda, Baudi

2005N-0345-EC226 - TEXT

Issue Areas/Comments

NO;

<1: 3.2>NO</1: 3.2>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.2>NO</2: 4.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.2>NO</3: 5.2>

<4: 6.1>YES</4: 6.1>.

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 7.4.4, 7.4.6>Last resort would be to ask those who look young to provide ID and to limit the sale to just one package.</5: 7.4.4, 7.4.6>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.1>YES</6: 8.1>.

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

N/A

GENERAL

<7: 2.1>Very disgusted that this decision is being based on political reason and not scientific. The FDAs mission is not being fulfilled when we have enough scientific data that ensures consumers that Plan B is safe & effective and yet no decision is made. FDA needs only to act on data, not politics. </7: 2.1>

COMMENT NUMBER - 2005N-0345-EC23

2005N-0345-EC23 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Parks, C

2005N-0345-EC23 - TEXT

GENERAL

<1: 1.2.1>This drug should be sold over the counter, period.</1: 1.2.1> <2: 3.7.2>If there are health risks to those younger than 16 or 17 years of age, they should be made very clear on the packaging of the drug. There are many OTC drugs sold in dosages that are not supposed to be given to children under a certain age, but the FDA has not initiated any special sales practices in order to regulate who buys those drugs. The same practices that are applied to other OTC drugs should be applied to this one.</2: 3.7.2>

COMMENT NUMBER - 2005N-0345-EC2314

2005N-0345-EC2314 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: National Research Center for Women

2005N-0345-EC2314 - TEXT

Issue Areas/Comments

<1: 3.2>No, a rulemaking on Section 503(b) is unnecessary.</1: 3.2> <2: 3.3.2, 6.3.4>The FDA notes in the ANPR that it has in numerous instances approved the dual marketing of an active ingredient for both prescription and OTC use in just this manner. The differences noted by the FDA between these products and Plan B (the age at which the user takes the medication and under what degree of medical supervision) are all simply various conditions of use of the product, and are along the same lines as these other differences in condition of use noted by the FDA. </2: 3.3.2, 6.3.4>

<3: 3.2, 3.3.2, 3.9.1>The supplemental application submitted at the request of the FDA presupposes a meaningful difference in the conditions of use ? in this case, the comprehension levels ?between the two populations. The FDA has concluded that users under 17 require a physician?s assistance, while users 17 and over can take the medication without that condition.

The dual marketing of Plan B to these respective populations defined by the FDA is permissible under Section 503(b). Because the FDA has found that the product is safe for OTC users aged 17 and over, OTC and prescription marketing of the same active ingredient is as appropriate with this drug as with any of the others approved for both OTC and prescription use. The FDA has customarily approved drugs for different conditions of use without requiring any statute, regulation, codification, formal or informal guidance. While these administrative tools are often used by the FDA, they have not been deemed necessary for the simultaneous marketing of an OTC and prescription product with identical active ingredients and dosages.</3: 3.2, 3.3.2, 3.9.1>

No, a rulemaking on Section 503(b) is unnecessary. The FDA notes in the ANPR that it has in numerous instances approved the dual marketing of an active ingredient for both prescription and OTC use in just this manner. The differences noted by the FDA between these products and Plan B (the age at which the user takes the medication and under what degree of medical supervision) are all simply various conditions of use of the product, and are along the same lines as these other differences in condition of use noted by the FDA.

The supplemental application submitted at the request of the FDA presupposes a meaningful difference in the conditions of use ? in this case, the comprehension levels ?between the two populations. The FDA has concluded that users under 17 require a physician?s assistance, while users 17 and over can take the medication without that condition.

The dual marketing of Plan B to these respective populations defined by the FDA is permissible under Section 503(b). Because the FDA has found that the product is safe for OTC users aged 17 and over, OTC and prescription marketing of the same active ingredient is as appropriate with this drug as with any of the others approved for both OTC and prescription use. The FDA has customarily approved drugs for different conditions of use without requiring any statute, regulation, codification, formal or informal guidance. While these administrative tools are often used by the FDA, they have not been deemed necessary to effectuate the simultaneous marketing of an OTC and prescription product with identical active ingredients and dosages.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<4: 4.2>No, there should be no confusion regarding the FDA?s interpretation of Section 503(b)(1).</4: 4.2>

<5: 4.4.1>Barr established, as required by the relevant regulations, that Plan B is safe and effective to treat a condition that can be diagnosed by the patient. Furthermore, Barr established to the FDA?s satisfaction that women could follow the directions for the medication that would render its self- administration safe and effective.</5: 4.4.1>

<6: 1.2.2>The FDA?s own advisory panel also overwhelmingly found that Plan B is safe and effective for use by women of all ages. The FDA?s finding that there is insufficient evidence on the use of Plan B for those under 17 presents no additional legal or practical concerns for its OTC use by women 17 and over. </6: 1.2.2><7: 6.1>The FDA has the legal authority to restrict an OTC product in this manner</7: 6.1>.

C. If so, would a rulemaking on this issue help dispet that confusion?

<8: 5.4.3>No, because there is no confusion.</8: 5.4.3>

<9: 6.1, 6.3.1, 6.4.1>The Office of Chief Counsel has previously determined that age restrictions for an OTC product are legal, as in the case of Nicorette nicotine replacement therapy. Furthermore, there is no indication that counsel was concerned that such a restriction would be unenforceable. A document regarding the approval of Nicorette for OTC status states:

Furthermore, the OGC has provided us with a legal opinion that it is possible under the FC&C act to impose restriction on the sale of the product to minors, if such restrictions are needed to ensure their safety.

The FDA?s decision that it has the authority to restrict the sale of OTC products to minors in the case of Nicorette applies with equal and full force to Plan B. While we disagree with the FDA?s view that Plan B has not been proven safe for the restricted age cohort, FDA has, on advice of its own counsel, made exactly the same kind of age distinction for Nicorette as it can make for Plan B in approving the drug for OTC use.</9: 6.1, 6.3.1, 6.4.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<10: 7.4.2, 7.4.3>It is the professional responsibility and ethical duty of pharmacies and pharmacists to abide by legally imposed restrictions on sales, such as age limitations. In the event that they do not do so, state boards of pharmacies and others with authority to deal with issues of professional responsibility can always step in, either directly or by notifying FDA.</10: 7.4.2, 7.4.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<11: 8.1, 8.3.4>The products should be sold in the same packaging. Not only would it be legal to do so, but it might be in violation of Section 502(a) to have different packaging if the drug works in the exact same way for every user. Having different packaging for OTC and prescription users would convey to the 16-year-old user that she is in some way taking a different drug than her 22-year-old counterpart, which would constitute misbranding under Section 502(a)</11: 8.1, 8.3.4>.

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<12: 9.2.1>No circumstance can be hypothesized where it would be inappropriate to sell the two products in identical packaging so long as: (1) it is the identical drug; (2) it is identically labeled for each user of the product; and (3) it has an identical method of action for each user of the product. </12: 9.2.1>

<13: 8.3.1, 8.4.1>OTC packaging is intended to be far more ?consumer friendly? than prescription products. According to the FDA, ?the intended uses, directions and warnings [for OTC drugs] have to be written so that consumers, including individuals with low reading comprehension, can understand them.? While important information for a prescription product may be buried in a lengthy insert, OTC products are required to have such information on the label. The current packaging for Plan B is appropriate for both OTC and prescription users.</13: 8.3.1, 8.4.1>

GENERAL

<14: 1.2.1, 3.2, 7.6>We strongly urge the FDA to abandon the proposed rulemaking, and to approve over-the-counter availability of Plan B for women of all reproductive ages based on its impressive safety record.

Greater access to this medication is likely to reduce the incidence of unintended pregnancy and abortion. The pharmaceutical and retail industries are well-equipped to handle the approval of Plan B as an OTC drug for those 17 and over, and as a prescription drug for those under 17. </14: 1.2.1, 3.2, 7.6>Thank you for your careful consideration of these comments. If you have any questions please do not hesitate to contact Diana Zuckerman, PhD at 202- 223-4000.

COMMENT NUMBER - 2005N-0345-EC24

2005N-0345-EC24 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Salvo, Aaron

2005N-0345-EC24 - TEXT

<1: 3.9.1>Currently there are several products that are available over the counter that are typically categorized as controlled substances, but there are also similar prescription productions. For example certain dosages of Ibuprofin are available by prescription only, but lower dosages can be purchased under brand names such as Advil, and there is nothing stopping a consumer from taking a single dose of the non-prescription strength product that would equal or even exceed the prescription dose. Also cigarettes are known to contain Nicotine, which is a narcotic, but Nicotine is now available as an OTC product in forms such as Nicorette Gum. Neither of these products have caused the FDA any consternation.</1: 3.9.1>

Again, there are currently products that are available in an OTC and perscription form. So yes that FDA should allow an active ingredient to be simultaneously marketed in both an OTC and prescription form.

<2: 6.1, 6.6.3>The FDA has enforced the sale of certains drugs without the assistance of a perscription. Once again alcholic beverages and cigarettes come to mind. A perscription is not needed for either product, yet the FDA limited access to these products by people below a specific age. Even though drinking ages are regulated by the states, there is at least precedence in law to keep a product out of the hands of a certain sub-population.</2: 6.1, 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<3: 7.1>The practicality of enforcement would be difficult, but no more than existing products available in both forms. </3: 7.1>As mentioned in previous questions a consumer may purchase an OTC Ibuprofin and take a single dose that would equal the perscription strength. <4: 6.6.1, 6.6.3, 7.4.1>Recently, however, certain states have take action to put certain OTC cold medications behind the phramacy counter and only releasing them in certain quantities to people 18 or older. Putting both forms behind that counter would allow an individual to get the required medication and put the oneous of enforcement on the store to verify that it is legal to dispense the product. Again much in the same way that people are "carded" for alcohol and tobacco products.</4: 6.6.1, 6.6.3, 7.4.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<5: 8.1, 8.4.1>In short I see no reason why separate packages would be needed. A person who could not legally purchase the product without a perscription would be stopped before leaving the store, unless they had a perscription.</5: 8.1, 8.4.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<6: 9.2.2>I see no time that it would be inappropriate to sell the two products in a single package.</6: 9.2.2>

COMMENT NUMBER - 2005N-0345-EC240

2005N-0345-EC240 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Cunningham, Wayne

2005N-0345-EC240 - TEXT

Issue Areas/Comments

<1: 3.1, 3.9.1>Yes, this is an issue that needs to be decided, and has certainly been resolved in areas concerning controlled substances. It's not all that new or novel.</1: 3.1, 3.9.1>

Yes.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.1>Apparently there is, since this question came up.</2: 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.1>Yes</3: 5.1>.

<4: 6.1>Yes. Other items have been regulated in a similar fashion.</4: 6.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 6.6.3, 7.1>It would be possible, just follow the examples set forth in how cigarettes and alcohol are regulated.</5: 6.6.3, 7.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.1, 8.4.1>They are the same product, so it would be unnecessary to have different packaging.</6: 8.1, 8.4.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 9.2.2>None</7: 9.2.2>.

COMMENT NUMBER - 2005N-0345-EC27

2005N-0345-EC27 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Pechacek, Deborah

2005N-0345-EC27 - TEXT

Issue Areas/Comments

<1: 3.8.1>Yes I think the FDA needs to clarify this rule to eliminate any future issues.</1: 3.8.1>

<2: 3.8.1>This definitely needs to be done to help Healthcare Professionals know when a product can be sold as an OTC product and when it can not</2: 3.8.1>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.3.2>Obviously there is since the Drug company is asking you to do something that I thought was not legal.</3: 4.3.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.1>YES!</4: 5.1>

<5: 7.5.3>I do not see how. In the case of "Plan B"; if you limit sales to 17 and older without a prescription, what is to stop 13, 14, 15 and 16 year olds with "OLDER FRIENDS" from getting the medication. The 17 year old "FRIEND" purchases it and gives it to the younger girls. Also you are opening up a great BLACKMARKET industry for the product.</5: 7.5.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.5.3>Again - I am at a loss as to how you will control and monitor where the product goes, once it is sold.</6: 7.5.3>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<7: 8.2>NO - they need to be in 2 separate packages.</7: 8.2>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<8: 9.1.2>ANY TIME</8: 9.1.2>

GENERAL

<9: 1.1>I think you are opening a major "can of worms" with this regulation. By allowing this to happen with one drug, you are opening the door for ANY product to use this logic. All the manufacturer has to do is show a reasonably safe side effect profile and then state that any adult is able to decide for themselves whether they want the medicaiton or not. I think we havae already put too many unsafe products out in the OTC catagory and do not need to add any more. </9: 1.1>

<10: 7.5.4>My other comment is about monitoring. How do you think you will prevent consumers in the NON-EXEMPT catagory from purchasing and either giving or selling the medication to people in the EXEMPT catagory? I see this as just a way for the drug manufacturers to shove their products out where anyone can buy them. This will lead to irresponsible use of medications. If we are not concerned about patient safety, the FDA might as well close down and let us buy everything in a local "DRUG STORE"... Viva la Mexico</10: 7.5.4>

COMMENT NUMBER - 2005N-0345-EC278

2005N-0345-EC278 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Endris, Kelle

2005N-0345-EC278 - TEXT

Issue Areas/Comments

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<1: 4.1>YES</1: 4.1>

<2: 6.1>Possibly.</2: 6.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<3: 7.4.2>Through Public Health Clinics.</3: 7.4.2>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<4: 8.2>NO!</4: 8.2>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<5: 9.1.2>Over the Counter</5: 9.1.2>

GENERAL

<6: 1.2.3>The Plan B emergency pill has the strong potential to end a conceived life. It should not be accessible to any under aged person for a variety of reasons. A minor does not have the maturity or understanding to know the long term impact of using such a drug. </6: 1.2.3><7: 1.1>Also, no person, should be forced to sell a drug, chemical or substance if it goes against that individual's religious or ethical beliefs. As a nurse, I would not assist with an abortion. A pharmacist should not be required to sell the Plan B pill if it is against his personal belief system. Generating a law to require an individual to do so negativley impacts that individual's constitutional rights. What are we becoming? </7: 1.1>

COMMENT NUMBER - 2005N-0345-EC281

2005N-0345-EC281 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: TomHon, Catherine

2005N-0345-EC281 - TEXT

<1: 3.8.1>This is purely dependent on whether this case represents an anomoly, which is not covered by section 503b. If this is so, then the restriction of OTC status is arbitrary and not based on a scientific basis. The question is whether one desires to leave future FDA drug approvals open to arbitrary arguments or whether the scientific integrity and strength of those decisions should be preserved.</1: 3.8.1>

<2: 1.2.2, 3.3.2, 7.3.1>I do not see that Plan B represents a unique case that in future should be used to influence FDA activity and decisions. It may be difficult to argue that the population <16 years of age is subject to greater harmful effect. But section 503b B, states that it (a prescription drug) is limited by approved application under section 505.... One could argue that the "Prescription Drug" status is defined by the limitations that must be spelled out in the approval of a drug application. It does not state that the FDA is limited in its approval and must define an approved drug as only OTC or prescription. Therefore it could allow the FDA via its official approval to designate the same drug as OTC and Prescription dependent on different circumstances, in Plan B's case age.</2: 1.2.2, 3.3.2, 7.3.1>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.1>In the particular case of emergency contraception - Plan B, yes. It is not clear why the FDA believes this section falls short.</3: 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.2>No, the FDA can simply make transparent and concrete the basis for its decision.</4: 5.2>

<5: 6.1, 6.3.5>Yes, it should be able to legally enforce the limitation. The FDA should also be able to act against off-label drug use. But whether the FDA does undertake enforcement is another question. To make this the deciding factor for approval means that the FDA should hold its legal ability to enforce, as a standard to be met by all drugs up for approval. Given the rise in the number of prescriptions dispensed for conditions for which the drug was never approved, this would swamp the FDA with enforcement issues.</5: 6.1, 6.3.5>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.3.2>In general, the FDA should be able to pursue punishments for all drug misuse by those professionals who are in charge of controlling drug access. These multiple levels of control to drug access include: Pharmaceutical industry, FDA approval, FDA approval only for specific conditions, MD prescription, pharmacy dispensal.</6: 7.3.2>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<7: 8.1, 8.3.1, 8.4.1>Yes for the following reasons:
- the product is the same, no confusion as to content.
- simplification of inventory for the dispensing pharmacy
- Instructions for usage should include those for all ages and include any age-specific issues.
- within power of pharmacist to control or deny sale, at point of sale

With the control of OTC products which can be turned into Crystal Meth, we have a similar issue. The access to the same active ingredient is controlled differently. One may be able to select it off the shelf in one pharmacy chain but need to request it from the pharmacist in another. These drugs may also be in the same package.</7: 8.1, 8.3.1, 8.4.1>

GENERAL

GENERAL

<8: 1.2>With the realization that this is a politically charged issue, I appreciate your wanting to cover all the loopholes. In the end the FDA should strive for the solution, which supports its mission. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation?s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.</8: 1.2>

COMMENT NUMBER - 2005N-0345-EC297

2005N-0345-EC297 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Levinson, R. Saul

2005N-0345-EC297 - TEXT

Issue Areas/Comments

<1: 1.2.2, 3.1, 3.8.3>Yes, there are instances where a professional may prescribe a product when he has contact with a patient, and instances where a drug product may be needed without prescribing professional interaction. This is certainly the case with "Plan-B"... as it is an emergency contraceptive, the user could be in a situation where there is no time for contact with a prescribing professional (weekends, holidays, afterhours, etc.)... and needs immediate access to the drug.</1: 1.2.2, 3.1, 3.8.3>

see above

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No confusion.... just old fashioned politics are entering into FDAs interpretation of section 503(b) of the act.</2: 4.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.3.2>Yes....especially since FDA's own advisory group, and the majority of the medical/scientific community support the availability of Plan B as an OTC product and a prescription product.</3: 5.3.2>

<4: 6.6.1, 7.3.1.1>The product could be sold only by licensed pharmacists who could determine if the requirements, if any, for OTC sale were met. Why is this so strange....FDA allows this with Category 4 and 5 controlled drugs, where allowed by individual State law.</4: 6.6.1, 7.3.1.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

Simple, see response above.

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<5: 8.1>YES</5: 8.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<6: 7.4.1>OTC product should not be sold to minors under the age of 16. Prescription product could be sold to any bearer of a legitimate prescription.</6: 7.4.1>

COMMENT NUMBER - 2005N-0345-EC307

2005N-0345-EC307 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Wu, Jackie

2005N-0345-EC307 - TEXT

Issue Areas/Comments

<1: 3.1>Yes. </1: 3.1>

Yes.

<2: 6.1>Yes. </2: 6.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<3: 7.1, 7.4.1, 7.4.6>In the case of Plan B, the subject needs to take the drug ASAP. The subject can buy the drug without prescription but still through the pharmacist window. She should take the first pill under the supervison of the pharmacist. An electronic pharmacy record will be helpful to track the number of drugs a subject takes. </3: 7.1, 7.4.1, 7.4.6>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<4: 8.6.4>Not critical. For practical manner, different package is easy to handle. </4: 8.6.4>

GENERAL

<5: 1.2.1>Plan B should be made accessible to those who have made the decision. If people decide that they can not afford the risk of being pregnant, they should have a choice to prevent it happening. </5: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC311

2005N-0345-EC311 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Waychoff, W. Aaron

2005N-0345-EC311 - TEXT

<1: 3.1, 3.8.5>Yes - the FDA should understand that, just like many other substances in our society, factors beyond simply the direct effectiveness and safety of the product on the human body must be taken into account. Many medications currently available OTC effect persons of different ages differently and carry labeling indicating such. In this labeling, use outside what is indicated by young persons is deferred to a physician's recommendation. Similarly, drugs such a Plan B could be made available OTC and carry labeling indicating that its use for women under 16 (or 17) is restricted to a physician's recommendation - in the form of a prescription. Remember, a prescription is little more than an official recommendation by a physician to use a particular medication at a particular dose.</1: 3.1, 3.8.5>

Yes - the FDA should understand that, just like many other substances in our society, factors beyond simply the direct effectiveness and safety of the product on the human body must be taken into account. Many medications currently available OTC effect persons of different ages differently and carry labeling indicating such. In this labeling, use outside what is indicated by young persons is deferred to a physician's recommendation. Similarly, drugs such a Plan B could be made available OTC and carry labeling indicating that its use for women under 16 (or 17) is restricted to a physician's recommendation - in the form of a prescription. Remember, a prescription is little more than an official recommendation by a physician to use a particular medication at a particular dose.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.2>The confusion is imagined on the part of the FDA. I belive that it is a trumped up excuse by Lester Crawford to stall the approval of Plan B because it does not meet with his personal religious beliefs and political aspirations.</2: 4.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.3.2>It would help as long as the rulemaking is not used simply to further delay needed medications reaching the hands of those in need. The rulemaking *must not be religiously or politically motivated*</3: 5.3.2>

<4: 6.3.5>As long as the subpopulation was not being discriminated against, and the limitation was in place for demonstrable safety reasons, it should be able to enforce the limitation by law.</4: 6.3.5>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 6.6.3, 7.4.5>Just like with cigarette and alcohol sales, there will certainly be those in a restricted subpopulation who will gain access to the drug. I do not belive that it will be necessary to enforce by law such a limitation. However it would be important not to punish the member of a subpopulation who obtains the product, but rather of the person(s) who enabled thier unlawful acquision of the product just as today the vendor or proxy is punished in underage cigarette and alcohol acquisition.</5: 6.6.3, 7.4.5>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.2, 8.6.2>I belive it should be packaged differently. A prescription form of the product should look traditionally like a prescription medication due to the psychological impact it would make - particularly to a subpopulation defined by young age. Since the reason for the restriction is to prevent misuse by young women (in the case of Plan B) it should look like a "serious" drug to this group who obtains it via prescription.</6: 8.2, 8.6.2>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 8.2, 9.1.1>When there would be significant confusion as to the intended recipiant of the product - for instance, if the same packaging was used for the non- prescription and prescription version (an idea I do not support) then the prescription version, at a minimum, must be marked with the standard information contained in a prescription label - name, directions, doctor, etc.</7: 8.2, 9.1.1>

GENERAL

<8: 2.1>I firmly and completely belive that this issue is being brought up as nothing more than a stalling tactic on the part of Lester Crawford. It is a shameful action and should result in the immediate expulsion of the man from his position at the FDA. It has shaken the confidence in the organization at the worst possible time. Lester Crawford is using his position to advance his own religious and personal beliefs and political aspirations. Though I feel that a clarification in 503(b) would be beneficial, it should not be used as a method for Lester Crawford to unilaterally impose his will on this country in direct opposition of all the scientific evidence presented. He can no longer be trusted to remain in such a position.</8: 2.1>

COMMENT NUMBER - 2005N-0345-EC319

2005N-0345-EC319 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Myers, Micah

2005N-0345-EC319 - TEXT

<1: 3.2, 3.8.8>There is no scientific or legal reason to have two packages containing the same drug at the same dosage with one only available by prescription. That being said, there are moral and political reasons to do so. Please do not engage in morality or politics.</1: 3.2, 3.8.8>

B. If it could, would it be able to do so as practical matter and, if so, how?

<2: 1.2.1, 7.2, 7.5.3>Practically speaking, this is ludicrous. Girls or women who need the drug will get by having a second source get it for them. And this is all right. Currently on the market is a potent hallucinogenic called dextromethorphan. it can be bought by most anyone, but only adults should be using the stuff really, because it has the capacity to seriously mess a kid up if too much is taken. Plan B does not have this same capacity. It should be available OTC with no restriction the same as DXM. Please ignore the politics of the issue and strictly make your ruling on the science.</2: 1.2.1, 7.2, 7.5.3>

GENERAL

<3: 1.2.1>Make the ruling on Plan B emergency contraception. While it may be true that you are receiving pressure from the religious right on this issue, the science is clearly in favor of OTC status. Comparatively we can easily look to other countries which have already labeled Plan B OTC, such as Canada. Have they had some kind of societal meltdown? Are there disproportionate health consequences for 15 year olds (that is opposed to the 15 year olds actually getting pregnant and carrying the fetus to birth)? Forget the morals and politics and look at the science. It has already been too long in the coming, and americans are actually starting to grasp the incompetence of any scientific agency beholden to elective branches of government.</3: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC32

2005N-0345-EC32 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Hagan, Jane

2005N-0345-EC32 - TEXT

Issue Areas/Comments

<1: 3.3.3>I believe the importance of making this drug available to the public is substantial emough that the FDA should do whatever is necessary to accomplish that.</1: 3.3.3>

I believe the importance of making this drug available to the public is substantial emough that the FDA should do whatever is necessary to accomplish that.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.2, 4.4.2>Since there is a desire to impose an age restriction on whether this drug is available with or without a prescription, there should not be significant confusion regarding whether the consumer is of a certain age or not.</2: 4.2, 4.4.2>

<3: 6.5.1>The answer to that question should be determined by safety issues only. If the product is safe for all subpopulations, it should be available to all subpopulations under the same conditions and without a doctor's prescription. There would be no limitation needed and therefore no law required.</3: 6.5.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<4: 7.4.4>If the product is not safe for all subpopulations based on age, then it should be limited by physician prescription and by law, and should be practical to enforce since age is provable and easily documented, particularly the age restrictions that are proposed. Both drivers' licenses and government ID cards are available for the subpopulations involved.</4: 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<5: 6.6.3, 8.4.1>Yes, just as other products such as tobacco and alcohol are limited to certain age subpopulations, this drug can be limited as well. Assuming enforcement will be at the point of sale, packaging should not be an issue.</5: 6.6.3, 8.4.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<6: 9.2.1>I cannot think of any, assuming that enforcement of restrictions is done at the point of sale.</6: 9.2.1>

GENERAL

See attachment

2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC

ATTACHMENT:

Additional comments as solicited by FDA on Plan B drug approval:

<7: 1.2.1>I have been following the course of approval of this drug for many years. I believe it is currently the only fair, practical and sane way to handle a very difficult and very personal physical and mental health issue. I believe this drug also takes the debate out of the realm of disagreement and confusion about whether a woman's choice to become pregnant or not is tantamount to homicide and whether the fetus feels pain or not upon early termination of pregnancy.

In my opinion it has already taken far to long, with far too much pain, sorrow and suffering, for this drug to get to this populations who need it. The FDA appears to be dragging their feet as they continue to focus on some details that seem spurious at best. Please get these details taken care of in a timely manner and get this drug out to the people who need it, who are all sexually active women over the age of puberty.</7: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC323

2005N-0345-EC323 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rupp, Charles

2005N-0345-EC323 - TEXT

<1: 3.7.2>The FDA needlessly creating controversy and confusion by suggesting that one drug in one dosage could be two difference products. This is at best a semantic difference (not substantive). This rulemaking by FDA is generating confusion and not resolving it. No one would suggest that a pint of whiskey is a different product when held by a minor than when held by an adult. Nor would anyone believe that a minor attempting to buy a pack of cigarettes makes the pack of cigarettes different from the pack purchased by an adult. The FDA is asking should rules be issued that would attempt to make such artificial distinctions. The FDA is suggesting that Plan B purchased for an adult is different from Plan B prescribed for a minor. The FDA is attempting to say the age of the consumer of a product changes the nature of the product. This is patently foolish. </1: 3.7.2>

<2: 3.9.1, 6.5.1>The example of ibuprofen cited by FDA in different dosages is in fact two different products. One, the 200 mg product is safe for the general public to self-medicate; however the 800 mg product requires significantly more knowledge to be used safely. Treating the 200 mg and 800 mg dosages of the same ingredient differently is reasonable and proper because of toxicity questions. This is the type of difference that should be controlled and indeed is at the heart of ?safe and effective? because the two items are not the same. Would the FDA consider regulating an 800 mg tablet dyed pink differently than an 800 mg tablet dyed yellow? I think not. The question is about the safety of the drug not cosmetic differences. The FDA should keep its focus on safety and effectiveness issues not on cosmetic differences (or non-existent differences).</2: 3.9.1, 6.5.1>

The FDA needlessly creating controversy and confusion by suggesting that one drug in one dosage could be two difference products. This is at best a semantic difference (not substantive). This rulemaking by FDA is generating confusion and not resolving it. No one would suggest that a pint of whiskey is a different product when held by a minor than when held by an adult. Nor would anyone believe that a minor attempting to buy a pack of cigarettes makes the pack of cigarettes different from the pack purchased by an adult. The FDA is asking should rules be issued that would attempt to make such artificial distinctions. The FDA is suggesting that Plan B purchased for an adult is different from Plan B prescribed for a minor. The FDA is attempting to say the age of the consumer of a product changes the nature of the product. This is patently foolish.

The example of ibuprofen cited by FDA in different dosages is in fact two different products. One, the 200 mg product is safe for the general public to self-medicate; however the 800 mg product requires significantly more knowledge to be used safely. Treating the 200 mg and 800 mg dosages of the same ingredient differently is reasonable and proper because of toxicity questions. This is the type of difference that should be controlled and indeed is at the heart of ?safe and effective? because the two items are not the same. Would the FDA consider regulating an 800 mg tablet dyed pink differently than an 800 mg tablet dyed yellow? I think not. The question is about the safety of the drug not cosmetic differences. The FDA should keep its focus on safety and effectiveness issues not on cosmetic differences (or non-existent differences).

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 3.8.4, 4.2>This question can be answer in one word: NO! The FDA is doing the equivalent discussion of 'how many angels can dance on the head of a pin'? The FDA interpretation of section 503(b) is straightforward and simple. This notice suggests that FDA will needlessly add complexity to what is otherwise clear and simple.</3: 3.8.4, 4.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 1.2.2, 5.4.3>As stated above, there is no need for additional rulemaking. If the FDA decides that additional rulemaking is necessary, the FDA should issue emergency rules and not delay yet again availability of a safe and effective drug. The FDA has already needlessly delayed availability of safe and effective contraceptive products to American citizens. This delay clearly has been to please a religious constituency and not in conformance with the purposes of the act. The FDA should cease its stalling immediately.</4: 1.2.2, 5.4.3>

<5: 2.1, 6.6.3>This question is easily and simply answered by looking at the American marketplace today. It is ordinary practice today to restrict sales of products at the point of sale by the age of purchaser. Even the smallest ?mom and pop? convenience store routinely enforces such restrictions in sales of liquor and cigarettes. Waiters and waitresses routinely check the age of customers before serving drinks. Sporting goods stores have no problem with age restrictions on the sale of firearms. Movie theaters restrict attendance at movies by age routinely. All of these examples demonstrate the capability of the marketplace to enforce age related restrictions on product. They also demonstrate that no extraordinary mechanisms are needed to ?train, inform, etc. retailers on age restrictions on products??age restrictions are everyday events in the marketplace. These examples also demonstrate that burdensome regulations about packaging of the products are not needed.

The effectiveness and workability of restrictions at the point of sale by age has been demonstrated in the American marketplace for years. The FDA should not ignore this demonstration. There is clear, strong and convincing evidence that age restrictions on sales are enforceable. If the FDA believes that some additional regulatory authority is needed to require the market to follow age restrictions at the point of sales, this should be done in emergency rulemaking and not be used as an excuse to further delay OTC sales.</5: 2.1, 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.4.4>The ordinary events of the American marketplace clearly demonstrated that age restrictions at point of sale are practical. There is no evidence to suggest that age restrictions on products at the point of sales are ineffective.</6: 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<7: 8.1, 8.3.1, 8.4.1>This question somehow assumes that different products would be sold in the same package. This is a patently ridiculous assumption. As argued earlier, the age of the purchaser does not change a product. Regardless of the age the purchaser, the product is the same. Again, FDA seems to be ignoring common sense to generate controversy and thus a reason to needlessly and inappropriately delay availability of this safe and effective drug over the counter.

The FDA could reasonably require that the age restrictions be displayed on the packaging for OTC sale. The FDA should not engage in the burdensome process of requiring one packaging for OTC sales and a different packaging for prescription sales. Clearly a packaging that shows OTC age restrictions should not cause any confusion in the mind of pharmacist about sale by prescription. FDA should not require separate packaging for OTC sales and prescription sales.</7: 8.1, 8.3.1, 8.4.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

. <8: 8.9>This question is another attempt to generate controversy needlessly. The question assumes that a meaningless distinction has been made and then assumes that the law recognizes the meaningless of the distinction and then asks the question whether legal sales would be inappropriate. The controversy suggested in this question exists only in the mind of the questioner.</8: 8.9>

GENERAL

<9: 3.2>The FDA acted irresponsibly in issuing the advance notice of proposed rulemaking. The FDA should have done an emergency rulemaking to address the subject of the proposed rulemaking. This advance notice suggests that the next step will be the issuance of proposed ruling. The use of bureaucratic steps to delay making a safe and effective drug available to the American citizens is unwarranted. </9: 3.2>

<10: 1.2.2>The questions in section II clearly miss the essence of the issue. In the press statement accompanying this notice, it is clearly that the rulemaking process is being used to delay over-the-counter (OTC) sales of the product known as Plan B. Since time is of the essence in the use of Plan B, using bureaucratic roadblocks to delay availability of a safe and effective drug deprives many citizens of the use of the drug during the period of the bureaucratic stalling. This stalling tactic is unethical and repugnant.

The question that should be addressed before all others is: Is there any reason to delay convenient access (and timely access is essential with the use of Plan B) to a safe and effective drug? The clear and unambiguous answer to this question should and must be NO! Emergency rulemaking is clearly the appropriate method to address any procedural questions that FDA perceives. In the absence of substantive reasons to delay convenient access to this safe and effective drug, the FDA's action should be to make this drug availability as an OTC product as quickly as possible. </10: 1.2.2>

COMMENT NUMBER - 2005N-0345-EC325

2005N-0345-EC325 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Llewellyn, Heather

2005N-0345-EC325 - TEXT

Issue Areas/Comments

<1: 3.8.4, 7.4.4>If an active ingredient in a drug has been ruled to be physically harmless enough for over-the-counter distribution, it should be marketed over the counter only. Rule-making codifications have already been set for drugs with active ingredients that have been ruled to be physically harmless enough for over the counter distribution but whose distribution might be deemed socially controversial. Please see the rule-making codification for alcohol and tobacco distribution. ID should be required to purchase it and guardians and police should be responsible for enforcing socially appropriate use. It is not the FDA's role to protect the public from physically harmless drugs or to monitor social use of drugs. The FDA's current "dilemma" is an egregious waste of tax-payer's dollars.</1: 3.8.4, 7.4.4>

If an active ingredient in a drug has been ruled to be physically harmless enough for over-the-counter distribution, it should be marketed over the counter only. Rule-making codifications have already been set for drugs with active ingredients that have been ruled to be physically harmless enough for over the counter distribution but whose distribution might be deemed socially controversial. Please see the rule-making codification for alcohol and tobacco distribution. ID should be required to purchase it and guardians and police should be responsible for enforcing socially appropriate use. It is not the FDA's role to protect the public from physically harmless drugs or to monitor social use of drugs. The FDA's current "dilemma" is an egregious waste of tax-payer's dollars.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 4.5>I am not confused by the FDA's interpretation. The FDA administration, however, sounds like it's confused about what to do because it is caught between the scientific findings of the FDA's own scientists and the political wants of the Presidential administration that appointed it.</2: 4.5>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.5, 6.6.3>Since I am not confused, it would not help me. It would not help the FDA's administration either, because then it could no longer delay taking appropriate action on the drug, therefore, putting it right back between the findings of it's own scientists and the wants of Presidential Administration that appointed it. In addition, there is no need for new rulemaking, as the rule-making precedent has already been set by the distribution of alcohol and tobacco.</3: 5.5, 6.6.3>

<4: 6.5.4>It is not the FDA's role to enforce it's rulings - that is the responsibility of distributors, guardians and the police.</4: 6.5.4>

B. If it could, would it be able to do so as practical matter and, if so, how?

It is not the FDA's role to enforce it's rulings - that is the responsibility of distributors, guardians and the police.

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<5: 6.6.3, 8.1>Of course - but the package should have warnings, just like alcohol and tobacco do.</5: 6.6.3, 8.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<6: 6.6.3>The package should have warnings, just like alcohol and tobacco do, preventing any circumstance that would be inappropriate.</6: 6.6.3>

GENERAL

COMMENT NUMBER - 2005N-0345-EC33

2005N-0345-EC33 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Collum, Mark

2005N-0345-EC33 - TEXT

Issue Areas/Comments

<1: 1.2.1>Plan B should be either OTC or available to be prescribed by a pharmacist. Pharmacists can verify if a patient is above 16yo, and can then allow it to be dispensed. However, a licensed RPh should be the one making the decision. This will satisfy the requirements that it only be available to someone who is 16yo. It will allow a label to be generated and offer the RPh to counsel the patient regarding its use.</1: 1.2.1>

<2: 3.1, 3.8.2>Yes. This should either be fully OTC or it should be classified into a category where RPh can prescribe and dispense it.</2: 3.1, 3.8.2>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.3.3>Yes. It is written entirely in legal jargon which most people cannot understand. In fact, even highly educated health professional must consult lawyers as to its interpretation. It needs to be worded such that a "regular" person can understand its provisions. Remove all legal jargon and replace it with intelligible phrases and words.</3: 4.3.3>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.2>NO! More rules only add to the confusion. Medicine & Pharmacy are too highly regulated as it is. More rules = more confusion.</4: 5.2>

<5: 7.4.1>Yes. If pharamcists are allowed to prescribe and generate a label for those greater than or equal to 16yo, anyone who receives it who is under 14yo must have received it from a phycisian. By making RPh generate their own prescription and treat it as such, there is a tracking method and accountability for anyone who receives the product.</5: 7.4.1>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.3.1.1>By allowing RPhs to treat Plan B as a member of their "prescribing class," you put the responsibility on their shoudlers. If someone under the age of 16 were to receive the product, it should have a physician's approval or the RPh would have violated his/her duties as a licensed professional and be subject to discipline.</6: 7.3.1.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<7: 8.2>No. Their packaging should be different and distinct.</7: 8.2>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<8: 8.6.4, 9.1.2>It is inapprorpiate to allow one single package to represent two products...that is deceptive to all parties involved.</8: 8.6.4, 9.1.2>

GENERAL

non

COMMENT NUMBER - 2005N-0345-EC34

2005N-0345-EC34 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Hudson, Ralph

2005N-0345-EC34 - TEXT

<1: 1.2.3>This question is asked twice in your webpage's form, with minor changes. In response to either wording, it does not make sense that birth control pills require a doctor's prescription, while an abortifacient drug may potentially be made available to teenagers without a doctor's professional guidance. An "active ingredient" is not being marketed for the same purpose in the case of the Plan B treatment, which is a high-dosage synthetic hormone treatment with the purpose of preventing implantation, not for the prevention of fertilization, which is the purpose of true birth control pills. The only valid comparison for allowing an active ingredient to be simultaneously marketed in both a prescription drug product and an OTC drug product is when the exact same active ingredient is being used for the exact same medical reason, in the exact same dosage. Allowing an abortifacient to be marketed OTC, while birth control pills require a doctor's prescription, simply because they both consist of the same synthetic hormone or combination of hormones (though in significantly different dosages) is disingenuous to the general public, by misrepresenting the completely different purposes for the drugs.</1: 1.2.3>

This question is asked twice in your webpage's form, with minor changes. In response to either wording, it does not make sense that birth control pills require a doctor's prescription, while an abortifacient drug may potentially be made available to teenagers without a doctor's professional guidance. An "active ingredient" is not being marketed for the same purpose in the case of the Plan B treatment, which is a high-dosage synthetic hormone treatment with the purpose of preventing implantation, not for the prevention of fertilization, which is the purpose of true birth control pills. The only valid comparison for allowing an active ingredient to be simultaneously marketed in both a prescription drug product and an OTC drug product is when the exact same active ingredient is being used for the exact same medical reason, in the exact same dosage. Allowing an abortifacient to be marketed OTC, while birth control pills require a doctor's prescription, simply because they both consist of the same synthetic hormone or combination of hormones (though in significantly different dosages) is disingenuous to the general public, by misrepresenting the completely different purposes for the drugs.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<2: 1.2.3>When the interpretation is potentially misused, as it may be in the case of the Plan B drug, there is significant confusion (or rather concern) about the true intentions and motivations behind the decision to allow an abortion drug to be made available to teenagers, based on the illogical comparison of the acts of preventing pregnancy with the act of preventing implantation of a fertilized egg.</2: 1.2.3>

C. If so, would a rulemaking on this issue help dispet that confusion?

<3: 5.1>It may dispel that confusion, if done correctly, but it will not "dispet" that confusion, as is written on your webpage.</3: 5.1>

<4: 6.5.4>This question requires a legal opinion, which is outside my qualifications. My layman's opinion is that, in the overly-litigious American society in which we now live, it is inevitable that there will be lawsuits brought in protest of age discrimination, unless a significant medical reason exists for the limitation.</4: 6.5.4>

B. If it could, would it be able to do so as practical matter and, if so, how?

<5: 7.1, 7.3.2>By the same methods currently used to enforce the separation of over-the-counter from prescriptions.</5: 7.1, 7.3.2>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<6: 8.2>Only if the goal is mass confusion and the complete breakdown of requiring that any drugs are dispensed only by a doctor's prescription.</6: 8.2>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<7: 1.2.4>Perhaps if the purpose is to terminate the life of an unborn child. </7: 1.2.4>

COMMENT NUMBER - 2005N-0345-EC343

2005N-0345-EC343 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Fisher, Julie

2005N-0345-EC343 - TEXT

Issue Areas/Comments

<1: 7.5.3>I very much doubt that the FDA would be able to prevent the sale of such a product to the prescription-only subpopulation by regulating pharmacies. What records are kept for OTC sales? None. And would nonpharmacy stores be able to carry the OTC product? What regulations would the FDA impose on convenience stores and grocery stores? </1: 7.5.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<2: 7.2, 7.5.2, 7.5.3>I do not believe there would be any practical way to prevent the OTC product from finding its way into the prescription-only segment. Pharmacies will sell the OTC product to the prescription population because there will be no deterrent to doing so. Those in the OTC segment will purchase the product and pass it on to prescription-only recipients. While the later can and does happen with drugs currently available only by prescription, such transactions are illegal. Would it be legal for an OTC consumer to purchase the OTC product and then transfer it to a prescription-only consumer? How would a ban on the transfer be enforced? </2: 7.2, 7.5.2, 7.5.3>

COMMENT NUMBER - 2005N-0345-EC364

2005N-0345-EC364 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: McLeod, Doug

2005N-0345-EC364 - TEXT

Issue Areas/Comments

<1: 3.1>Yes it should and the decision should be made to allow this action. Especially if the scientific evidence supports that decision.</1: 3.1>

<2: 3.3.3>Yes it should allow active ingredients to be simultaneously sold as both an OTC and a prescription drug. This is especially so when the FDA experts have reviewed the drug and indicated that it should be available as an OTC product.</2: 3.3.3>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 1.2.2, 4.1>There seems to be when political pressure overules the science and expert opinion regarding the drug. For example the Plan B morning after contraceptive has been overwhelmingly rules as safe yet the FDA seems to be racting in response to political pressure rather than scientific evidence. This is clearly the wrong direction for the FDA.</3: 1.2.2, 4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.3.1>So long as the rule allowed the practice and supported by the scientific evidence and advice of the FDA professional staff who should be independent of political influence.</4: 5.3.1>

<5: 6.3.5>This decision should only be taken if there is hard scientific evidence that a subpopulaion would be harmed. A subpopulation could be by race, age, sex, ethnic origin etc. The FDA should not make a political,ethical or morality based decision to restrict access to a subpopulation unless the scientific study group advises it to do so for scientific reasons.</5: 6.3.5>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.2, 7.6>It could not, so do nnot try. If the drug is deemed safe by the scientific community for suitability for OTC, then do not apply further restrictions as to availability.</6: 7.2, 7.6>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<7: 8.1, 8.3.1>That is not so much a legal question as a marketing question. Often prescription drugs are dispensed in different containers than they are shipped to a pharmacy in. For example a large container of medecine is used to allocate to small vials for dispensing purposes. OTC products, on the other hand, are often packaged for theft protection, daily dosage packaging, colorful, informative packaging, sale price or incentive packaging (IE 50% more for free). I would answer YES to this question, but on practical terms, the packaging for the prescription product could change to adopt to an OTC style.</7: 8.1, 8.3.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<8: 9.1.1>It may be inappropriate for a prescription drug to be packaged in an OTC package when the volume of the drug, or expected duration of consuption is different. For example, an OTC drug, such as the Morning After Contraceptive pill may be sold in single dosage OTC packaging, whereas the same drug could be sold in a daily dosage strength intended to match a womans menstral cycle.</8: 9.1.1>

GENERAL

<9: 1.2.2>I have never written to the Food and Drug Administration before, and was motivated to comment on this particular issue because of an apparent breakdown the FDA leadership to avoid political influences. In particular, the Plan B, morning after contraceptive drug issue is motivating me to state my outrage that the scientific community and staff of the FDA are overrules or ignored when political pressure is applied. This is unconcionable. The FDA decisions should be made on scienctific evidence, and not by the political desires of a supbopulation. </9: 1.2.2>

COMMENT NUMBER - 2005N-0345-EC365

2005N-0345-EC365 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Deneris, Angela

2005N-0345-EC365 - TEXT

Issue Areas/Comments

<1: 3.8.1>YES!!! We need to make this process much more simple and bring these medications to the American public sooner.</1: 3.8.1>

<2: 1.2.2>YES!!! This is a safe medication which will lower the abortion and unplanned pregnancy rate in this country. This medication has extensive study and has very few side effects.</2: 1.2.2>

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.1, 4.3.2>YES! I think the public and providers are very confused about the process and the length of time it takes to make a decision.</3: 4.1, 4.3.2>

C. If so, would a rulemaking on this issue help dispet that confusion?

<4: 5.1>I would think so.</4: 5.1>

<5: 6.1, 6.6.3>YES! We do now with tobacco and alcohol. I see no reason that a pharmacist couldn't ask for ID. They do so now with Schedule I and II medications.</5: 6.1, 6.6.3>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.1, 7.4.4>YES!!! This would not increase the amount of time or money in asking for ID.</6: 7.1, 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<7: 8.1>YES! I see no reason for different packaging.</7: 8.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<8: 9.2.2>NONE</8: 9.2.2>

GENERAL

<9: 1.2.1>I feel this product should be available to every woman needing contraception, regardless of age. I believe we make it too difficult for people to get this product, which then needlessly subjects women to unwanted pregnancy. This is tragic. Too many lives are affected. Too many abortions happen that could be provented. Please pass this medication on to be OTC to EVERYBODY! </9: 1.2.1>

COMMENT NUMBER - 2005N-0345-EC38

2005N-0345-EC38 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Scarpace, Sarah

2005N-0345-EC38 - TEXT

GENERAL

<1: 1.2.3>I am offering a comment specific to the change in status of Plan B to OTC. I am a clinical pharmacist and assistant professor. I have absolutely no qualms at all about dispensing Plan B OTC and counseling patients regarding the product; however, I am very concerned that should the drug be available OTC, that many women will not receive the appropriate triage necessitated in the cases of rape, especially HIV and STD testing, as well as social work and other psychological support interventions available in emergency rooms. This would especially be true in the case of date rape and rape by a person known to the victim, where she may feel ashamed and embarrassed to go to the ER. How would these circumstances be avoided?</1: 1.2.3> <2: 6.5.4>I also do not think that we can strictly enforce the sale of these products to only age 16 and I am not sure why the drug would not be safe to any young woman who has reached menarche as the ingredients are the same as the branded birth control pills Nordette (R), Lotrel (R), etc., which may be used by women younger than 16 to control painful mentstrual periods/ heavy flow. Does a 15 year-old rape victim not have the same rights as a 16 year-old?</2: 6.5.4> <3: 6.6.3, 7.5.3>If the drug is approved truly as OTC, where the patient could buy the product out in the aisles (as opposed to approving for "behind the counter" to be sold by a pharmacist only), would the store front cashier be responsible for deciding the appropriateness of "carding" a patient for the product to determine age? We know how effective these young adults are in regards to the sale of tobacco and alcohol! I also see a danger in not having some type of "screening" to ensure the safety of the patient in the respects mentioned above in regard to STD screening and social work support - the pharmacist can mention this during a counseling session but your average high school cashier working at minimum wage is not going to provide this level of attention (nor should they) to these patients. Please do not regulate the medication without considering the circumstances surrounding it. </3: 6.6.3, 7.5.3><4: 3.8.2, 7.3.1.1>Yes, the medication itself is likely safe; however, there is special monitoring/intervention required for the medication which makes professional triage and not OTC availability in the best interest of the patient. The best scenario is to find a mechanism to ensure that these patients are seen by a physician in the ER, but the next best option is to at least utilize pharmacists as the fail-safe. Most pharmacists take this responsibility seriously; the recent media attention regarding pharmacists refusing to fill these prescriptions was in my view, embarrassing to the profession, but also highlighted a small minority of practice by pharmacists, probably equal to the percentage of physicians who hold similar ideologies. </4: 3.8.2, 7.3.1.1>Thank you for your valuable time in considering these comments.

Sincerely,

Sarah L. Scarpace, Pharm.D.
Assistant Professor of Pharmacy Practice
Albany College of Pharmacy
106 New Scotland Avenue
Albany, NY 12208
phone: (518) 694-7226
fax: (518) 694-7302
email: scarpacs@acp.edu

COMMENT NUMBER - 2005N-0345-EC399

2005N-0345-EC399 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Tufts, Gillian

2005N-0345-EC399 - TEXT

Issue Areas/Comments

<1: 3.1>Yes.</1: 3.1> <2: 1.2, 3.8.3>The manner in which many OTC drugs are used differs from the manner in which the prescribed drug of the same ingredients is used. For example, rare use of Plan B in the emergency situation has been found to be safe. The daily use of the same drug, with potential use for years, does require monitoring and education by a licensed prescriber. Although the drug used in both the emergent and preventative situations has been found to be safe, there are rare but potential health consequences with chronic use. In general, oral contraceptives have been taken by millions of women around the world and are safe.</2: 1.2, 3.8.3>

Yes, see question A.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

<3: 4.2>No.</3: 4.2> <4: 1.2, 3.8.4, 4.4.1>From the brief that I have available, I believe I understand the intent of the reasoning behind OTC use and prescribed use. Of importance here is the indication of the drug use. Plan B is to be used only in the emergent situation, after intercourse has occurred, to prevent an unintended pregnancy. The drug is not meant to be use daily to prevent. "The key distinction in these examples is that there is some meaningful difference between the two products (e.g., indication, strength, route of administration, dosage form) that makes the prescription product safe only under the supervision of a licensed practitioner." The previous quote is from the docket, I believe the key difference is the indication of the drugs' use.</4: 1.2, 3.8.4, 4.4.1>

C. If so, would a rulemaking on this issue help dispet that confusion?

<5: 1.2.1, 6.7>I do not believe it is necessary to limit the use of a drug, specifically Plan B, to subpopulation. Again, the drug is meant to be used in an intermittent fashion only, like taking tagamet HB for heartburn. Neither drug is meant to be used on a daily basis. That is where seeing the health care provider is indication and the information regarding the drug in the drug insert should reflect this.</5: 1.2.1, 6.7>

B. If it could, would it be able to do so as practical matter and, if so, how?

<6: 7.5.3>I believe it would be difficult for the person actually selling the product to monitor and enforce the selling of a product limited by age. </6: 7.5.3><7: 1.2.1>In the case of Plan B, I believe that this may inhibit some from obtaining the drug much needed in an emergent situation!</7: 1.2.1> <8: 6.6.3, 7.4.1>Such enforcement would likely require that the drug be stored 'behind the counter', like cigerettes, and many women who would benefit from the intended use of the drug would not ask for it.</8: 6.6.3, 7.4.1>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<9: 8.2>No.</9: 8.2> <10: 8.6.1>As with many drugs that are available OTC and prescribed, the indication and manner in which the drug is taken differs. As with Plan B, the indication and number of pills required for the emergent versus daily use differs. If the number of pills needed and the manner in which the medication is taken differs then it follows that the packaging should differ. The OTC and prescribed product appear different because they are different. The intended use and manner in which the medication is taken is different between the two products.</10: 8.6.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<11: 8.2, 9.1.1>I do not believe the two products should be sold in a single package. If the intended use of the two products differs, then so should the packaging and the information in the package inserts.</11: 8.2, 9.1.1>

GENERAL

<12: 3.8.3>As a medical provider, I believe that it is safe to have two products be legally market to the general public.</12: 3.8.3> <13: 8.9>It is very important to have clear the intended use, how to use the medications, the side effects and what to do if the intended use has not resolved. Often the intended use for the OTC and prescribed product differs. For example, with oral contraceptives, the daily use is meant to prevent an unintended pregnancy, whereas the emergency contraceptive, such as Plan B, is meant ONLY for those situations where no preventative contraception has been used and intercourse has occurred. </13: 8.9><14: 3.8.1>Please consider the changes to the code 503B and permit the use of the same ingredient in OTC and prescribed medications. I believe the availability of both products will well serve the general public. </14: 3.8.1>

COMMENT NUMBER - 2005N-0345-EC4

2005N-0345-EC4 - STRUCTURED DATA ELEMENTS

Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Bilz, Michael

2005N-0345-EC4 - TEXT

Issue Areas/Comments

<1: 3.8.8>Has it done so for Ibuprofen? It is sold both ways today.</1: 3.8.8>

Has it done so for Ibuprofen? It is sold both ways today.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

I don't know, is there?

C. If so, would a rulemaking on this issue help dispet that confusion?

<2: 5.5>I'm sure that it would - how long would it take to make a rule? Longer than it did when so many people were denied access to the Alzheimer's medication that sent so many people back into the darkness and so many families living with the torment of seeing a loved one suffer? There was a miss-step for the Agency, as it were.</2: 5.5>

<3: 6.7>Do they have a vehicle for enforcing it now? If so, what is it? Is it effective?</3: 6.7>

B. If it could, would it be able to do so as practical matter and, if so, how?

<4: 6.6.3, 7.4.4>If there were an age limitation - it would become the responsibility of the Pharmacy provider to determine age - like we do for tobacco and alcohol. Now how does a fifteen year old girl prove her age without a parent? I sell tobacco to people only with a proper I.D. and I challenge everyone that looks younger than 27. Like Alcohol + Tobacco - why wouldn't underage persons solicit the help of someone of legal age to buy this for them? The controls you ask for here have historically had work-arounds since their inception.</4: 6.6.3, 7.4.4>

A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

<5: 8.1, 8.4.1>Why not? They both do the same thing and the manufacturer sells these very same products in slightly more socially-concious countries and would then raise the cost of the drug by creating alternate packaging for various applications - and the cost would be passed onto the end-user, not the drug company.</5: 8.1, 8.4.1>

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

<6: 9.2.2>I can't think of a situation where it would be an issue.</6: 9.2.2>

GENERAL

Dear FDA, I will start by saying that I respect your job and I feel the American consumer is safer, as a whole, for your agency's regulations on both food and drugs. I understand that it must be a difficult position to make these tough decisions regulating for people that cannot answer for themselves - and most of us are unaware of your role in our lives...as it should be. <7: 1.2.1>In regards to the Plan B Emergency Contraception ruling I believe that it is today, it was yesterday and it will be tomorrow a WOMAN's right to choose what is best for her body. No MAN should be allowed to legislate one way or another over a WOMAN's reproductive rights. Plan B E.C. has a specific application and it's use should NOT be regulated by the 'moral' or 'religious' convictions of any individual. Plan B should be on the shelf next to all other contraception, accessible to all persons. Yes, I agree that underage girls should be challenged for proof of age at the register - but first we need to have stronger Health + Sex Education in our school systems from an early age to allow all persons to be able to make an educated decision on what is best for their Body AND Mind. We're not stupid, we're just under-educated. Start education early and have an informed public. Plan B is important for everyone - I'm tired of supporting unwanted pregnacies through social programs that show children as a dollar figure to a poor family. Reform the social welfare systems and EDUCATE the population - STARTING TODAY..!! </7: 1.2.1>
Thank you for listening.
Sincerely,
Michael L. Bilz

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