Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -197

Accepted - Volume 4

Comment Record
Commentor Ms. Margaret Little Date/Time 2002-07-25 20:50:25
Organization Ms. Margaret Little
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? As a consumer, I like to make up my own mind on what supplements or even drugs I am/or will take.
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 don't feel it does any harm for a patient to question a doctor or ask a doctor about a certain drug they saw. Doctors seem to be overworked and have a hard time keeping up with new drugs. By asking, my doctor looks it up and then makes a recommendation to me as to whether the drug would be suitable for me. I feel it adds to my optimal care.
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 am very interested in maintaining my own health, many people do not seem to be. I don't feel that very detailed labels on anything are going to change many people's eating habits.
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 you feel it necessary to put disclaimers on products - size does not matter to me. I will still continue to read and make my choices that way.
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? Consumers follow warning only if it suits them. More warnings or rules are not going to change that.
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 have obseved that putting warning labels on cigarettes has not really stopped people from smoking. Most ads have disclaimers at the bottom. That's enough for me.
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 don't believe that permitting off-label discussion of a product undermines anything.
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? I hope that the FDA does not take away the freedom to talk about foods or dietary supplements. People encouraging others to eat more veggies and fresh fruit are the way many people will learn to make healthier choices. I don't feel more government control will help.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Please let people tell other people about things that help them. Let us keep the right to talk about what works for us. We don't need or want the government more involved.

EC -197