Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -20

Accepted - Volume 1

Comment Record
Commentor Mr. Fred Hornblower Date/Time 2002-05-28 20:51:53
Organization Mr. Fred Hornblower
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? Drugs frequently address symptoms by blocking normal functions of the body, while most supplements simply provide resources for the body to use. Drugs also tend to have far more serious side effects than prudent use of most supplements. I believe those side effects need to be displayed and/or advertised far more prominately than they are today.
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? I am truly sorry to read that the FDA considers a large part of their mission to cause an increase in physician visits. I was hoping the primary mission of the FDA was to ensure purity of our food sources, dietary supplements, and drugs. Foods with fewer traces of hormones and antibiotics, fewer trans fats, and better overall purity would help decrease the need for physician visits. I would feel better if I could depend of the FDA to concentrate most of its energies in that direction.
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? I feel as long as a label uses the term may aid rather than making an absolute promise of cure, that it should be deemed acceptable.
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, especially side effects on drug labels.
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? I don't follow any warnings. I study nutrition far more than 99% of the physicians, choose my own dietary supplements, and discard many prescriptions (mainly pain prescriptions) given to me by my physician.
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? I believe the public is influenced more greatly by advertisements than by labels. Most people I talk to freely admit they don't even read labels.
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? I must reiterate that I consider the evaluation of product purity to be the primary mission of the FDA.
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? All I need to know is whether the FDA has evaluated a product or not.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Increase the size of side effect warnings in drug advertisements and on labels. Side effects should also be stated more slowly on Television and Radio commercials.




EC -20