Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -431

Accepted - Volume 6

Comment Record
Commentor Dr. James Ajemian Date/Time 2002-09-15 20:23:05
Organization n/a
Category Individual

Comments for FDA General
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? The fact that such detailed questions posed by this government form for the average citizen to respond to suggests strongly that there is serious question about whether such advertising concerning the health of the citizens in the U.S.A. should be allowed at all. No pharmaceutical producing corporation should be allowed to advertise any of its products at all via any advertising media. The law should require a complete ban on advertising by pharmaceutical corporations directly to the consumer as well as to the medical profession. All new drug and other pharmeceutical products by drug companies should pass through review by an empowered FDA that will then disseminate the information to the medical profession.
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? If members of the medical profession learn about drugs from their patients rather than from a reliable source, what conclusion can one arrive at? Advertising itself of medical products based on competition certainly will skew and create false impressions by citizens in need of medication into pressuring their doctors for all the wrong reasons. This is truly scandalous.
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? First it should be acknowledged that the very questions raised in the above (3) imply strongly that corporations tend to lean toward misleading and incomplete dissemination of listings on food labels, despite current laws. Again, competition itself breeds the pressure to mislead. In the health industry there should be no competition, just the concern for the citizen's health. Health products and their corporations should be heavily regulated by the government as a public utility, with limits on profits and expansion.
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? N/A N/A
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? All warnings should originate from FDA approval on all medicines and clearly marked as FDA warnings. Thus any product approved by the FDA automatically should assume that the product is safe with the side effects and contents listed.
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? See (3) above.
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? Corporations, as a public utility, should have the right to respond to FDA interpretations of their products, positive or negative, and engage in discussion with the FDA if they disagree with FDA findings of their new products. Further, no individuals employed by the FDA at any level should be directly or indirectly involved with any of the drug companies under the scrutiny of the FDA. Conflict of interest is prohibited, including the transfer of individuals from drug companies to government administration and the reverse as well where government apointed individuals in the FDA would have a direct interest in a drug company.
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? The FDA, as regulator of a public utility, should be at the forefront to dispense health information made available to all health organizations, practitioners, hospitals, clinics, and pharmacies on a timely basis. It should be open to inquiries from the medical profession, pharmacies, other professional health organizations and the public at large.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? See all of above.

EC -431