Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -16

Accepted - Volume 1

Comment Record
Commentor Dr. Victor A. Marcial-Vega, MD Date/Time 2002-05-28 20:20:16
Organization Health Horizons Inc.
Category Health Professional

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? Constitutionally speaking, no one can tell anyone what to say or not say unless you can PROVE that these comments are detrimental or can hurt or kill someone. Detrimental, killing or hurting is the definition of infringement on other person's freedom of speech or constitutional rights. This is very clearly stated in the Declaration of Independence and the Bill of Rights.
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 simple fact is that more than 100,000 people die from adequately prescribed drugs each year in the United States. This is what you must be exploring and not these other peripheral questions. Are you investigating these ocurrences? What is the FDA doing to solve this crisis?
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? The disclaimer is a voluntary act. The Constitution protects individuals on freedom of speech rights.
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? There is evidence that nutritional suplements are very safe. There are only 190 deaths related to them over 3 years(versus close to 400,000 with drugs). My opinion is that the FDA 9is spending too much time in an issue that does not merit their attention. More attention is needed where more harm is being noted.
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? Again, anyone has the right to say whatever they deem to be true according to their own experience.
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? No, it would not undermine it. The FDA has ability to regulate speech only when they have PROVEN without a doubt that these supplements cause harm, kill or maim.
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. The FDA's regulations are definitely slowing progress in the fields of nutrition and health. These findings on supplements should and must be encouraged by the FDA. Not supressed.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Of course. Support the will of the people in obtaining nutritional suplementation and approaches that may save their lives and quality of life.

EC -16