Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -327

Accepted - Volume 4

Comment Record
Commentor Mr. Les Joos Date/Time 2002-09-05 12:22:08
Organization Mr. Les Joos
Category Individual

Comments for FDA General
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 consumer's right to know must supercede any commercial right for promotion. This information must be delivered in a way that consumers can readily understand, not veiled in technical jargon.
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 point is accurate information that conforms to rigorous criteria designed to ensure consumer safety. If you want to talk about benefits, you must give appropriate attention to side effects. The message -It's not right for everybody should be clearly stated with reasons why.
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? Dietary supplements exist in a space between food and drugs. I would not object to a label that said a particular herb or supplement was commonly used for a specific purpose as long as there was also a disclaimer that said this conventional use was or was not substantiated by approved clinical trials and included any contraindications for its use.
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? Equal size for claims and disclaimers.
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? Warnings can not be in tiny mouse type or jargon. Beyond that, it's the consumer's obligation to read them.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Public safety and the right of the individual to be accurately and fully informed should trump any commercial right to free speech.

EC -327