Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -391

Accepted - Volume 6

Comment Record
Commentor Ms. Joann Gatten Date/Time 2002-09-10 22:24:41
Organization University of California Library
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? Commercial claims for product effectiveness for health should be based on fact independently derrived, not on research by the same company which is promoting its products. Children need special protection from the advertising claims of businesses. Children are vulnerable to commercial advertising, and it is unethical to target them as consumers. Hiding behind the First Amendment as a right of commercial advertising is particularly deplorable!
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? There isn't enough regulation of the Chemical medicine industry, nor enough testing of potential products, after the political dismantling of FDA labs in the past. Take the big business lobbists out of the medical field! This should not be an area for stockmarket speculation for getting rich. Now our prescription drugs are killing patients as much as their diseases! Medical interns tell me that chemical industries give big parties for interns, and it works - the interns go to the parties and the chemical companies give out large amounts of samples. Also, I worked as a medical secretary years ago, and the salesmen were constantly at our door. The doctor had a closet full of free samples. The doctor was an easy mark for the salesmen.
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? An administrative record should contain reports of the population who have used the diet supplement, but gathered by the FDA, not the company with a vested interest in its own product.
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? Disclaimers should be in the same or larger size of type, and given equal prominence. For relevant research, go beyond current politics, and go back into the history more than a few years. If there isn't relevant research, use relevant anecdotal evidence (reports by people who have used the product, not just handpicked testimonials.
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? There is nothing more arresting than negative symptoms to make me think twice about using a drug. When there are negative symptoms listed, chances are I'm one of the ones who get those symptoms. If the drug isn't absolutely necessary and if it isn't my only choice, I'll be very careful.
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? Advertisements have become particularly insidious in recent years. They are often violent in content, and use subliminal psychology to program the TV viewer, for instance, to unconsciously desire the product. Thus, children harrass their parents to buy products advertised on children's TV programs. The products are often very expensive, to make parents lives particularly miserable.
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? It depends on how much regulatory integrity the FDA is provided by the current Republican administration. If the field of public health had not been gutted by big business lobbyists, we would have more public education about all our health issues, not just this season's fads.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Do not give away the rights and the necessity for the protection of children to so-called free speech rights of adult business profiteers.

EC -391