Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -96

Accepted - Volume 2

Comment Record
Commentor Mr. Wayne Kelly Date/Time 2002-06-01 13:55:55
Organization Mr. Wayne Kelly
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 FDA's function is not to regulate speech. This has been emphasized in many court cases, most notably the recent Supreme Court case, in which the majority found in favor of free commercial speech, as is protected in the Constitution. The old maxim, Let the Buyer Beware, still holds true. It is up to the consumer to make educated choices about any dietary supplements that are purchased. Theinherently misleading statements that the FDA seems so concerned about are a fact of modern life. The FDA, used car salesmen, politicians and many others use inherently misleading promotional speech quite often. So to take a position that the FDA must protect the public by limiting free speech is an insult to the American people who can certainly read between the lines.
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? Let's be honest for a change, shall we, and skip all of the slick verbiage. Of course drugs are over prescribed. Of course the drug industry wants dietary supplements controlled, banned or discredited because they can't be patented in most cases. Let's compare the number of cases of death and injury by prescription drugs per year as compared to any death and injury from generally safe and economical dietary supplements, shall we? We both know there is no comparison, don't we? Yet the public is purchasing ever increasing volumes of these dietary supplements numbering in the billions of dollars in sales with negligible health risks. What is the FDA supposedly protecting us from? Who is really being protected here? Shall we follow the money?! Let's consider Tryptophan, a highly effective safe and economical amino acid supplement aiding those with insomnia and depression, which the FDA pulled off of shelves due to a tainted batch from one manufacturer. Good excuse. Now I can only get it through a prescription from an MD who will instead insist on me taking an expensive drug (Prozac) with numerous side effects. Who is being protected here? Does the FDA also permanently remove a drug from the market when an isolated batch turns up tainted? I wonder?
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? Just tell the truth. What a novel concept! Again, Let the Buyer Beware.
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? It is the job of the FTC to worry about truth in advertising, honest commercial free speech, etc, not the job of 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? The FDA's intentionally fear-inducing and totally unnecessary, This statement has not been evaluated by the FDA, below product descriptions on dietary supplement containers should be removed immediately from all such products. It is not relevant.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Just obey the Supreme Court's ruling and the clearly defined freedom of speech rights in the Constitution. Protect the public, not the drug companies.

EC -96