Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -22

Accepted - Volume 1

Comment Record
Commentor Ms. Virginia Riker Date/Time 2002-05-28 21:04:00
Organization Ms. Virginia Riker
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? Speech about drugs should be regulated because drugs are made by entities who are motivated by profit. When one is motivated to make a profit, one often has no motivation to create a harmless product. Especially, when a cheap product will suffice for the purpose of making a profit. Dietary Supplements on the other hand, are composed of safe substances created by God or nature. Even when the compounder is motivated by profit and their statements mislead the user, little if any physical harm is done. If the consumer spends money and gets no results from a natural supplement surely he is happier than the the cosumer who tries drugs, gets no results and finds that he has devastating side effects from the drug which was carefully contructed for maximum profit.
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? How many young people have taken up the smoking habit since the warning label was first put on every package of cigarettes? This is some sort of evidence that some consumers will disregard warnings if they are warning of something that may or may not happen to an individual in the distant future.
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? Why don't they just put their own scientifically supported statement on any product they think is unsafe for whatever reason and also allow supplement makers to make reasonable claims based upon scientific studies. If the two voices disagree, then so be it. Let the consumer choose for themselves by reading BOTH statements on the label. As a consumer, I do not want to be protected from differing opinions, but would rather decide for myself. I expect the FDA to simply state their case and let me decide.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think they should allow reasonable statements on supplements and foods and save their energy for the daunting task of regulating claims made about DRUGS that are thousands of times more dangerous and have a list of debilitating and killer side effects as long as your arm.

EC -22