Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -34

Accepted - Volume 1

Comment Record
Commentor Mr. George Mesmer Date/Time 2002-05-28 23:04:52
Organization Mr. George Mesmer
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? Overriding is the First Amentment on free speech. About 98% of the business community will tell the truth in their advertising. They are not inherently misleading. Go after the 2% snake oil vendors, but leave honest people go about their business in peace. Criminals will ignore the law anyway. It is the FDA's job to go after criminal not honest citizens.
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? The heavy onslaught of pharmaceutical ads on TV shows tends to lead people who do little background reading to go looking for these drugs in drug stores an self medicate. Some of these drugs are so strong, that a dependency on them may result. Their advertising should be heavily restricted. On the other hand, Vitamines and natural plant extracts that are not drugs, do not lead to a craving/dependencies. They do not constitute a threat to ones health and therefore have little need to be regulated by the FDA.
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? Any claims, by anybody, who offers drugs, food supplements or foods should be able to back up such claims. Labesl should say whhat kind of testing,observation, anecdotal evidence is referred to. The source should be named and be exhibited in a public place like the internet or a library or a journal for anyone interested to see for himself.This is the age of information. Let's use it intelligently to help people make intelligent decisions.
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 given in the same size print. It is valuable information, isn't it?
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 in a type that stands out (bold , color, italicized, underlined, etc. Warnings should always include side effects to ones health. If there aren't any, say so.
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? Advertisement is one thing. People recognize it as such. A label is attached to the product. If the label on a product is pure advertising it would be misleading. Labels should simply state contents and application or usage and dangers in using. Advertising should appear separated from the product physically so it is recognizable as such.
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? Off label uses should concern the FDA only in so far as these uses are food or health related. If they do, and the manufacturer wants FDA approval, he'll have to do the tests. Otherwise he needs to say on his label NOT FDA APPROVED.
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 could take the advice from the Court to heart and act accordingly. Right now it is acting overzealously and assumg rights, that were never given to it. In fact it thinks it is above the law. No government agency is. It should look at the definition of an agency, who gives it its mission, and what is that mission in a narrow sense.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? That's a matter for the Court to decide.

EC -34