Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -158

Accepted - Volume 4

Comment Record
Commentor Ms. Leigh Mouring Date/Time 2002-07-25 09:13:11
Organization Ms. Leigh Mouring
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? We have a health crisis in this country. Drugs are great for short term remedies and I believe drugs should be regulated, however dietary supplements need to have more information available to the general public so we can learn how to maintain our health through natural means. Please do not limit our ability to help ourselves.
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? Doctors should have their hands untied so optimum health can be managed at the Doctor's office as well as at home. Doctor's need full knowledge and access to both dietary regimens as well as drug regimens.




EC -158