Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -195

Accepted - Volume 4

Comment Record
Commentor Mrs. Teresa Leporati Date/Time 2002-07-25 20:39:12
Organization Blessed Health
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? Consumers need to be made aware that there are alternatives available to them. It is not constitutional to favor the pharmacutical companies. Freedom of Speech should include the right of companies other than pharmacuticals to be able to express and/or explain the (possible) benefits of their products. The American consumer is entitled to this information and to make their own decisions concerning medications and/or suppliments.
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? Death by properly prescribed drugs is the fourth leading cause of death in our country. The majority of comercials on T.V. are now for prescription drugs. When doctors in India went on strike the death rate went DOWN. Does this tell us something? Is anyone listening? Does anyone care? It's time to take control away from the pharmacutical companies and allow consumers to be aware there are alternitaves. It's also time we let doctors practice medicine, being able to prescribe or reccomend alternatives and no longer be run by pharmacuticle companiesand insurance companies.
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? 'why don't you check out what some of the other more liberal countries are doing?
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 readable.
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 right on labels
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? Make a law that the claims have to be the same in ads and on labels.
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? There is a company out of Texas who seem to be doing a good job with this. Check them out and compare others
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? Have the same guidelines for all companies, it seems that would simplify things.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Give all companies a chance to get the word out about their products not just pharmacuticals.

EC -195