Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -331

Accepted - Volume 4

Comment Record
Commentor Mr. Johnathan Conley Date/Time 2002-09-05 13:07:50
Organization JComm LAB
Category Individual

Comments for FDA General
Questions
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? Yes, there are arguments for regulating speech about drugs. The administrative record should acknowledge the success of tobacco and junk food industries to dupe children who have not learned how to detect advertisers fallacious panderings. Yes, the FDA should acknowledge that too much of advertising is inherently misleading. The FDA test of requirements should be widely known and understood as well. Anything promoted on national TV should be considered a strictly consumer approach. Ads directed toward professionals should be specification and test-finding oriented. The evidence is a rising population of teenage smokers. Some of this is encouraged by the US government. For example, my last visit/tour of a Job Corp facility in Montana did not display any incentives for kids to quit/not start smoking; which was reported as 60% of their population.
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? No. The FDA's current position is not consistent with empirical research in regard to the tobacco industry. Absolutely NO ADVERTISING should be allowed of this or any other poison. The negative effects of the drug company's advertising is the cultural instilling of a pill ethic, instead of a personal responsibility - life-style ethic. Yes, drugs are over-prescribed. The profit numbers affirm this. Personal experience indicates a broad spectrum of ineffective results from using those drugs. I do not think that the advertisements per se support clients in following a health/life style pattern, but their pills get purchased and used. Under-diagnosis is a plague within the health care industry. The pill selling does not seem to help. Based on results, the pill advertising does not lead to adequate treatment of under-diagnosed diseases. The risks of a certain drug are mentioned. I doubt that they are understood from a 30 to 60 second spot. Yes. FDA's and industry's approach impedes optimal medical advice in several ways. 1. Pill first instead of life-choice review. 2. The latest pill instead of a cheaper more effective and proven pill. 3. Plenty of free samples, so the patient is introduced to a often more expensive drug, instead of trying something else.
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? A conspicuous three symbol rating on EVERY consumer item that may affect anyone's health. 1. First symbol would be a heart. No-heart (place marked by a flat line) would indicate that on best research this product would be unhealthy for your heart. Half heart, full heart would indicate the the composite result of consuming the salt, sugar, the interactions between various components of fats contained, etc. would be heart friendly(er). 2. Second symbol would be flower with 8 petals. No petals and just a stem would indicate harmful chemicals used in the production of this item. The healthier and more organic, the more petals on the flower. 3. The third would be a sun symbol (round circle with rays extending). A flat line would indicate that the production of this item was done in an environmentally unconscious way. Full sun and rays would indicate a product whose manufacture was done in an environmentally friendly and future sustainable way.
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 the largest of the print. The claims should be smaller.
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? Warnings should be tied to death statistics placed on a website. The website should be VERY user friendly. Addictive product warnings seem to be disregarded. This could be tested by placing the warning label on cigarettes saying: This product will kill you!!
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? Obviously corporations are given first amendment rights. So should the Government. All relevent social and physical science evidence should be used to make sure labels support the citizens it represents.
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? Yes. The consumer will try the off-label use, whether it was approved or not. The FDA will probably not be able to control it, rather the consumer should have easy access to accurate and easily understood information (see 5) about the off-label use.
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. Over 400,000 people are still dying of tobacco related causes every year. An alternative would be to create speech parity, that is, for every claim made by a manufacturer, require time/space to be given to a consumer advocate to possibly refute the claim made by the manufacturer. The manufacturer better have their data and facts straight, or they will be discredited.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Please get rid of any and all cigarette/tobacco product advertising. Do not allow Phillip Morris to put their name on any feel good ads they use to subliminally sell their poison.




EC -331