Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -23

Accepted - Volume 1

Comment Record
Commentor Mr. DeWayne Williams Date/Time 2002-05-28 21:28:28
Organization Mr. DeWayne Williams
Category Other

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? There is no argument for the FDA regulating free speech. Consumers determine that now and continue to buy proven drugs that have positive effects beneficial for health. Additionally, who wrote these questions. They are as misleading to consumers as they come.
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? No. People mistakenly feel safe with prescription drugs when in fact they kill thousands of people annually. Yes, certainly when doctors get kickbacks and 85% of all physicians own stock in pharmaceutical companies. No. No. Yes, most certainly.
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? Say that some evidence apparently shows that this or that supplement has positive effects for whatever it is. It will then be up to advertisers to prevent the studies so that informed citizens can decide for themselves. Assertions are just that. Most consumers I know aren't stupid when it comes to their health. Some people listen to the FDA because they have a warped view of what its mission is.
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? Same size is fine.
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? Consumers who know the truth think the warnings the FDA makes are ludicrous.
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, it does not give the Government the right to circumvent the First Amendment.
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? What the hell is an off-label use. Please speak English.
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? Absolutely not. They do just the opposite. I would think so, but since it is a government entity I seriously doubt it.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Quit regulating supplements which have no harmful effects. Saying nothing would be tantamount to approval rather than saying these haven't been evaluated by the FDA.




EC -23