Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -100

Accepted - Volume 2

Comment Record
Commentor Mrs. Darleen Johnson Date/Time 2002-06-02 14:09:15
Organization none
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? I am currently taking products that are not regulated and feel entitled to the availability of those products over the counter. It is my own responsiblity to determine the reasonable safety of such products. I do not appreciate the interference of the FDA.
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 current approach does create an atmosphere that makes many physicians reluctant to prescribe products that are safe and often work better than prescsription drugs. I am more concerned about the lack of safety with drugs currently allowed by the FDA.
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? In the past I have used over the counter products that have not been allowed to state what the product is actually designed for. It is ridiculous for the FDA to restrict the labeling of most of these products.
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? Advertising of prescription drugs is far more dangerous to me than being concerned about the disclaimers and sizes of such. Advertising on TV makes consumers apt to be influenced by the heavy hype for products that may not be suitable.
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? Obviously the current warnings of not accepted by the FDA are ignored as we know this is not a good reason to decide not to use a product.
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? Manufacturers should be free to tell us what their product will do regardless of approval by 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? No,no, no!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The free market will guide people to using the best products. Word of mouth often determines what we buy. If it is good we will tell others.

EC -100