Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -198

Accepted - Volume 4

Comment Record
Commentor Mr. John Greenfield Date/Time 2002-07-25 22:47:33
Organization Mirrorr Records
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? All biological activities should be rated on the same scientifically based standards. Information such as the treatment of mild to moderate depression using St. Johns Wort (which can be said in Germany) is not allowed to be said here. In Germany, if you by a bottle of this herb the label folds out like the label on one of our pharmaceuticals. The level of comprehensive information includes nutrient deficiencies / potentiation effects of the herb as well as possible drug interactions, safe dosage and countraindications. The net result for Americans is that side effects and drug-herb-nutrient interactions are under reported here because the consumer and physician are largely underinformed. Science is science. Good science makes good education. Why are we undereducating our consumers in the land of free speech?
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? How about optimal health advice? THe is a lack of integration from the top down; from med school to practice, doctors are taught very little about anything but pharmeceuticals. Now pharmeceuticals are the largest advertisers on TV, and have significant lobbying resources in on capitol hill, but scientifally speaking (because I am a scientist) we are still at a level of technology that can not touch plant dynamics. - eg: We have yet to creat photo-synthesis in a laboratory. This is the very least of a plant's abilities. Pharmacological activities in herbs and biological potentiation using various nutrients, has to be put on the same practical playing field as drugs if we are to have a unified approach to all aspects of treatment / risk as well as cost issues.

EC -198