| Comments for FDA General |
| Questions |
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1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction?
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The issue rests simply on this, the FDA has the capability to assess the safety and effectiveness of a drug in a manner that the public simply does not. If the FDA were to abnegate its responisibility in this realm, which would be the obvious consequence of direct-to-consumer advertising that would occur under these very liberal applications of free speech, than there is simply nothing to protect the consumer. A consumer does not have the full resources that the FDA does in determining the positive or negative value of a drug and to pretend that the drug companies will offer truth in advertising is highly naive. Therefore, it is quite likely that direct-to-consumer advertising by drug companies that do not comply with FDA requirements could in fact be a threat to the public, if they are not aware of the potential hazards of the drug advertised, and the drug company (under the guise of free speech) do not disclose those hazards. Also, the market could be flooded with unregulated claims concerning effectivness that has not been determined by the FDA. The effect of this could be just as detrimental to public health, especially when a seriously ill individual is guided by unregulated advertising to a particular drug, which in fact will have no positive impact upon their health. Such a scenerio could lead to avoidable injury or death.
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2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment?
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The current approach could be improved upon. It has been shown (as with studies concering tobacco) that advertising is a highly effective method to spurn desire, where previously it may not have existed; that is the nature of advertising. As a result of this, drugs that may not be needed by but a very few, are now demanded by many due to current advertising. I, myself, was having insomnia for a few weeks and was ready to call my doctor for Ambian, due to their television advertisements, when in fact I simply needed to make a few lifestyle changes that have not only helped me sleep, but have benefited my overall health - benefits that I may not have reaped had I made that call to my doctor based on advertising. It should be the doctors, at the recommendations of the FDA who pass out prescriptions, not consumers who demand them because of an advertisement they saw between Ford and McDonalds commercials. Therefore, I think the current position could and should actually be revised to include a much more conservative approach to these advertisements.
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3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently?
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Certainly one would hope that consumers would approach claims about conventional foods and supplements differently, but the job of the FDA is to protect those consumers from potential dangers and it is an abnegation of responsibility on the part of the FDA to assume that the consumer can figure out the relevant information concerning supplements on their own. If the consumer could come to various products fully aware, then there would be no need for the FDA, but we all know this is not the case. I believe that supplements have gone too long without FDA scrutiny and, sadly, at the cost of human lives (for instance in cases involving Ephedra). The FDA should force regulation of these supplements and subsequently these supplements should carry all information concerning the product that is relevant to public health on their labels.
There is another factor as well that should be considered, and that is quality control. As it stands these supplement companies can market a product with claims that may or may not be true with products that may or may not contain the real product. Part of the FDA's scrutiny of these products should be in testing and assuring quality control of the products that are being sold to the consumer.
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4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue?
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In short, yes. If they are of the same size (rather than tucked away in very small print) the consumer can make a fully informed choice concerning the product.
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5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard?
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Traditionally warning occur on the back of a bottle and because of habit, I am sure this placement would be fine. But given the nature of what has been an unregulated supplement market, I believe that a warning should be placed in its traditional place on the back, but coupled with an obvious notation on the front that the product does contain an FDA warning on the back. I believe something like the following would suffice: *FDA WARNING ON BACK.
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6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels?
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I believe that the adversiting medium effects the consumer more immediately and, because it is often the consumer's first exposure to a product, most effectively. As a result, special care should be given to these advertisements. It is certainly possible that a consumer upon seeing an unregulated advertisement may assume a product to be safe and purchase it, and even use it, without reading the label warnings.
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7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses?
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Absolutely allowing anyone other than a doctor to recommend off-label uses would undermine the requirement that new uses must be approved by the FDA. This seems so obvious that it hardly requires comment. Again, it is the FDA's responsibility to protect public health and that health cannot be fully protected when drug companies, or anybody else involved in the sale and marketing of a drug, are making unsubstantiated and potentially dangerous claims concerning their drugs. To allow this to occur makes a mockery of the very purpose of the FDA as a regulatory body. If a use has not been evaluated, regulated or approved, and yet a drug company or their associates makes claims promoting such use, then the FDA as a body is being circumvented at a serious cost to public health. Unless a use has been approved by the FDA, it simply should not be allowed to be promoted to the populance.
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8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech?
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I believe that such regulations do advance the public health concerns they are designed to address. I think loosening those regulations would only allow for further abuse by drug companies at the cost of the public's health. If anything, I think regulations should be tightened concerning restictions of speech in terms of companies promoting their product.
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9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority?
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I believe that companies should further be resticted from advertising in print media or television for the reaons listed in my response to question 2. Allow doctor's the discretion to determine what, if any, drug will actually benefit their patient, not advertisements.
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