Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -155

Accepted - Volume 4

Comment Record
Commentor Ms. Gabriella Roleff Date/Time 2002-07-21 19:02:06
Organization Ms. Gabriella Roleff
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? The Pharmaceutical companies have such overring influence over the FDA because of the money they are making in drugs and have no concern for the public health. So the disclaimers on the labels are confusing and discouraging to the public. They are missleading, because the body needs nutritional supplements to help prevent disease not man made drugs.
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 FDA should have claims on prescription drugs.
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? The public is entitled by the First Amendment to have free access to information about Nutitional products. And the people will decide what they want to use. So no disclaimers should appear on the supplement lablels.
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? No, you are scaring people away from nutritional products that help the body prevent disease. Don't write disclaimers. It is health vs profits.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Get rid of disclaimers that confuses and discourages consumers from trying a nutritional supplement for better health.

EC -155