Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -248

Accepted - Volume 4

Comment Record
Commentor Mr. James Bateman Date/Time 2002-07-28 22:08:04
Organization N/A
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? The government (FDA) needs to be harder on the pharmacutial industry, which dispenses toxic/poisonous drugs. Drs and consumers should be better informed about the toxicity and dangers of the drugs they are dispensing and consuming. Don't just put it in the small print that is hard and confusing to read. Drs should be better informed on how the drug works and be able to relay that to his patents in language they can understand. The FDA should stay out of the dietary supplement area. DSHEA already exist for that purpose. DSHEA could require toxicity levels, if any, unless that amount required is much greater than the recommended doses. DSHEA could also require the source of the supplement (natural or synthetic) and how much is absorbed
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? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? YES Do they increase physician visits or patient compliance with medication regimes? YES Do they cause patient visits that lead to treatment for under-diagnosed diseases? YES Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? NO Do they lead to adequate patient understanding of the potential risks associated with use of drugs? NO 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? YES
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? FDA should stay out of this area all together. Leave it to DSHEA.
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 on drugs should be larger, and on radio and TV they should be slower and laugher. Claims on drugs 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? Do more testing on drug side effects before approval. Too many have been approved too early only to be proven to be too dangerous to the public. Maybe the FDA (individuals) should have some real liability for the harm that is done then maybe they would be more careful.
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? Don't know.
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? When the FDA has proof of lying or misleading statements they should prosecute with great vigor and penalties. Hitting them in the pocket book hard will do the most good.




EC -248