Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -356

Accepted - Volume 6

Comment Record
Commentor Mr. Gregg Holbert Date/Time 2002-09-06 15:23:46
Organization Mr. Gregg Holbert
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? There are arguments for regulating speech about drugs more comprehensively than dietary supplements. The FDA should maximize its ability to regulate commercial speech. It should not cross over into the individual's rights of free speech. Corporations do not have the rights of indivuduals and are already too powerful in the realm of communications.
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 do not know the answers to these specific questions. But the FDA should have the power to regulate such communciations.
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? The current food labeling that was implemented not voluntarily, but through the exercised power of the FDA, is the best thing since sliced bread. Information - particularly accurate and honest information - is a lubricant that maximizes the benefits of our free market economy. Dietary supplements have gone too far in most cases regarding claims they make. They often do have disclaimers, but the FDA should have the authority to regulate these more fully.
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? I believe the disclaimers should have the same prominence as the claims.
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 do not know the answer to this. But I feel too much information is better than too little!




EC -356