Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -139

Accepted - Volume 2

Comment Record
Commentor Mr. Hans R. Jost Date/Time 2002-06-24 00:47:39
Organization Mr. Hans R. Jost
Category International

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? For Drugs it must comply to FDA (no if an when). For dietary supplements no restricting rules must apply, but product liabilities and can consequental liabilities must apply. Any mentioned claims must have an evidentiary basis. The claimer can randomly be choosen to provide acceptable evidence of his claims. The claims should not be labeled but all and complet Ingredients must be labled including amounts. All listed Ingredients maus have equal readable font size.
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? For Drug, All known positive and all negative effects should be listed in equal readable font size on a attached drug descriptions. Any drug sold or hand over to an consumer or patient must be accompanied with an complete readable and consumer understandable drug descriptions.
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? Wished that lables list all and complete Ingredients in equal font size. Any labled claims should be labled if FDA approved. For non FDA approved claims nothing should be labled. Consumer can read in seperate liturature about such indicative claims but not on the lable.
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? all font should be of equal size, disclaimers as well as claims.
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? Use the same type of warnings as used on cigaret packages if evidence for applicable warning are proven available.
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? Food supplement and medicine should not get public advertisments other than its avialability in the shop markets.
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? Just have no claims on the lable at all.
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? Speeches should not be restricted but FDA should randomly ask provider of such speech to prove there claims. Further the provider of wrong claims must be liable by law panishment enforcment if default can be proven.

EC -139