Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -84

Accepted - Volume 2

Comment Record
Commentor Mr. Robert Rupe Date/Time 2002-05-31 06:39:55
Organization Mr. Robert Rupe
Category Individual

Comments for FDA General
Questions
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 has no business regulating any speech or claims. The onus should be on the FDA to disprove any claims.
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? The negative effect of the industry's promotion of prescription drugs is an overuse of drugs that are just as dangerous as over the counter supplements.
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? There is not a lot of difference between conventional foods and dietary suplements. Therefore the same rules should be in effect.
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? Disclaimers should be in the same size type as claims as they are just as important.
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? Any warnings should be written on the item. If people can't read or won't pay attention that is their problem.
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? Claims made in advertisements and on labels should be consistent. NO!!!
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? No. Because the item already passed whatever FDA approval was required once. There is no point in going through the whole expensive, time consuming process again. The FDA should have very little ability to regulate any speech.
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? No. The FDA ignores anything that doesn't come from the major drug companies regardless of the effect on public health.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? There should be another process in place for supplements that cannot be patented as the process for FDA approval is too expensive to pursue the efficacy of such products.v




EC -84