Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -432

Accepted - Volume 6

Comment Record
Commentor Mr. Micah Myers Date/Time 2002-09-16 12:27:48
Organization Mr. Micah Myers
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? In both situations there are corporations trying to promote their products, not educate people on those or other products. In both situations the corporations are simply trying to maximize profits. When it comes to drugs however, I think the corporations are intruding on a special, personal relationship, that of doctor and patient. The drug companies are interjecting their product with no knowledge of the individual cases that product may impact.
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? DTC ads are not helpful to anything but the corporate bottomline. The drugs are out there, and the doctor surely knows about them. the doctor is the first step in promotion after all, even before the consumer. The best person to talk with patients about the risks of drugs is the doctor. DTC ads make us forego this important relationship, because the FDA should never let a drug company advertise without telling the facts. People swinging, and telling us how wonderful they feel after taking Paxil...this is not facts. This is corporate balogna. The best thing to do is cut DTC advertising alltogether.
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? People will eat most anything in a grocery store, and most don't consider dietary supplements a health risk regardless of what it is or says. You should evaluate the possible danger to public safety compared to the benefits of public knowledge.
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? Government, or govt. required, information should be given the prominence it deserves. It is more important than the ad itself.
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? Tell us the facts boldly, and at the beginning and end of any ad. The facts are much more helpful than the ad itself after all.
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? Corporate advertisement, on the label or in public advertisement, should be treated the same. The government should have greater latitude over both, even at the expense of these rights-to-advertise granted to non-humans.
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, it directly undermines it. You give consent to a product, because it has been considered safe. If that product is changed into another product, you should be able to regulate corporate promotion of it. After all, it is not the same product.
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 don't feel as if corporations should have a right to advertise, or free speech as some call it. My view is that you should challenge those rights if they are interfering with the public well-being. Corporations are not the public; they are not people.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? You should follow number one priority: Protect the people. If we the people think that your protection is getting out of line then we will let you know.

EC -432