Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -129

Accepted - Volume 2

Comment Record
Commentor Mr. Larry Wood Date/Time 2002-06-17 23:28:39
Organization Mr. Larry Wood
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 FDA would be best served not taking a position of dietary supplements beyond the claims that any individual supplement represents any sort of cure or general remedy.
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? Direct consumer advertisements increase public awareness of medications on the market, but also contribute to self diagnosis, and there are too many physicians willing to accomodate persistent patients.
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? Dietary supplements should be treated the same as conventional foods and the present labeling is sufficient to establish the content and determine the benefit of them.
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? Research is not necessary to prove that small type font is harder to read and more often ignored than larger. All type should be the same, however, brief and to the point in laymen's terms.
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? Statements should be factual, honest, and succinct. The responsibility is on the consumer to decide what to disregard.
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? No evidence can or should be used to support distinguishing types of claims. A simple statement of the source and it's relationship to the product is sufficient.
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? Permitting free speech by stakeholders does not undermine the act. The consumer is ultimately responsible for using any product. Disclaimers are already required to accompy such comments. It might be useful to diplay them more prominently.
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? Speech regulations do not advance public concerns. The FDA would gain more credability by publishing factual information on the benefits of preventative and natural health treatments vice supporting the view that every ailment can be cured by prescription drugs.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA practices currently appear politically motivated and influenced greatly by lobby. We have more effective health and medical advances available than ever before, yet there is a greater disparity between those who can afford it and who cannot. Realizing that most doctors have little time for individual researcy and rely heavily on the FDA, FDA needs to re-focus on what would be most beneficial to the people of the US and less on what's politically correct or generates the most revenue.

EC -129