| Comments for FDA General |
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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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Yes, I certainly believe that speech about drugs must be tightly regulated, more than currently is the case. There is too much profit to be made in new drugs for drug companies to be expected to regulate themselves in the absence of stringent laws. This must apply to advertising and speech directed both at consumers and at medical professionals. The American public should not be the Guinea pigs of drug companies who claim safety or benefits, due to lack of regulation, where neither really exist.
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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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I never see pharmaceutical advertisements that prominently display the risks of the product. Such risks should be required to be printed in type as large as that which promotes the drug, and not in near-microscopic print. The current mode of hiding statements of risk, and the lack of patient understanding to which it contributes, definitely increases the potential risks of using drugs.
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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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Disclaimers should always be required to be in large type, and given equal prominence with claims. The health of the public is more important than the reputation and profits of the advertiser.
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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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Warnings can be made most effective by being placed prominently on the front of packaging. Chances of consumer confusion and inattention can be minimized by having stringent requirements that dictate the prominence with which such warning messages should be displayed, and which give guidelines for the type of concise speech to be contained in such warnings.
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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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If the (vaguely worded) question here is whether the First Amendment gives corporations the right to make whatever claims they want on labeling, the answer is a resounding no! The First Amendment was written with the intention of protecting the free speech of individuals, and not of corporations.
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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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Such promotion off-label usages, without the oversight of the FDA, are really only a ploy for selling more of a product by means of subterfuge. A product should only be allowed to be sold and promoted for the purpose for which it was created and then tested and regulated.
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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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The FDA's speech-related regulations are woefully inadequate to advancing the public health concerns they are designed to protect. Speech which promotes the sale and usage of a product with potentially dangerous consequences or side effects ALWAYS needs to be regulated. There is no meaningful alternative to the vigilant monitoring and restriction of advertising and marketing speech, for it is through such speech that the public overwhelmingly gets its information.
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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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Yes. What should change is the artificial focus on promoting and protecting the First Amendment rights of corporations to say whatever they want about their products, and to somehow imply that this right is as important as the public's right to be protected from fraud in advertising, and from the health damage or even death that can result from it. Such a focus is simply a contortion of the meaning and intention of free speech protections.
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