Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -273

Accepted - Volume 4

Comment Record
Commentor Ms. Teresa Whyte Date/Time 2002-07-29 18:19:21
Organization Ms. Teresa Whyte
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? Dietary supplements derived from natural plants etc. and not tampered with by genetics and unnatuaral subjects should not be treated as drugs. Obviously honesty is necessary and should be handled as any other advertising, but FDA should not be involved.
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? Industry promotion of drugs is misleading with regards to conflicting medications. Also, the minor adjustment of a drug in order to keep prices up should be considered illegal. The FDA has lost a lot of ground in consumer respect. Approvals given, people die, approvals recinded. Too late. Drug industry seems to have too much control over FDA, including the attempts to remove vitamins etc from personal control.
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? No differnce. A person who is knowledgable is generally the one who uses dietary supplements. Generally before using a product the consumer will research not just accept claims that seem extreme.
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? Readable without microscope
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? Current warnings are sufficient. Too much more makes people stress.
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? Generally the public takes any add with a grain of salt. We are not stupid and know advertisers are out to get our money and are not above stretching the truth to just this side of illegal.
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? FDA is not to regulate speach. It is to approve/disapprove products. Only relationship is in packaging to telling of the truth.

EC -273