Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -292

Accepted - Volume 4

Comment Record
Commentor Ms. Lynn Campbell Date/Time 2002-07-30 18:03:11
Organization Ms. Lynn Campbell
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? Dietary supplements should not be regulated at all. Drugs should not be advertised at all.
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? Many drugs cause bad side-effects and are misunderstood not only by the patient, but also by the doctors recommending them.
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? We want to know what is in our food and food supplements. We want to be able to educate ourselves about what is good for our bodies.
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? If it were not for unreasonable regulation and enforcement about food and food supplements, there would be no logical reason for manufacturers to have to waste space on labels for disclaimers. It is mandatory that people be allowed to educate themselves on this issue. Then they could make informed decisions based on the knowledge of what the food or supplement actually contains.
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? Make it possible for people to obtain unbiased information without restriction on this subject.
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? This would be a non-issue if people were able to obtain an unbiased education on the subject. Then it would be obvious which claims were false.
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? The FDA should not be able to regulate speech. Period.
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 is ineffective in advancing the public health, as has been shown by the amount of illness which still exists and is not being cured by their regulations.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Probably most of them.




EC -292