Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -173

Accepted - Volume 4

Comment Record
Commentor Mr. Franklin Johnson Date/Time 2002-07-25 15:39:07
Organization Mr. Franklin Johnson
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? At firt glance, with prescription drugs being the fifth leading cause of death in the US, this may seem like a good idea. However, the tendency seems to be to throw dietary supplements into same pot as drugs which is a bad idea. Drugs being the fith leading cause of death does not inspire mush confidence in FDA's ability to oversee the drug industry. Whereas the dietary supplement industry, which I have not heard or found any statistics coming near the death rate of drugs, relying on freedom of speech - word-of-mouth advertising is proving to be the method of choice for more and more Americans to find what WORKS for them.
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 drug industry already has its built in (paid)promotional group, the AMA and its sales force of thousands of doctors. Overprescription of drugs - definitly. The FDA and AMA guidelines definitly imped doctors ability to give optimal medical advice or prescribe optimal treatment.
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 same. I would assume so, advertisers do not put out advertising without research to determine what influences the consumer. Phrases, size, color, all have influences on the consumer
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? Again advertising experts know what works. So is the inforamtion presented meant to influence or inform.
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? Advertising purpose is to sell. A label should be straight forward information.
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. Yes let the evidence and science be its guide. It is doing it with the drug industry now. The proliferation of drug advertising in the media with their disclaimers must be accepted practice already.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes, keep politics, money and self serving interest out of the equation. Case in point the influece of Monsanto in continuing the production of Aspartame having to be sued by the MS Foundation and the FDA. Why is it that every industrialized country in the world EXCEPT the US has banned rBGH (growth hormone for cows made by Monsanto) milk? Unbiased investigation, science, information does not need the First Amendment to defend it. Present the information let the consumer make their decision. Just as the Tobacco industry has to take reposibility of its actions and now the smokers themselves with the higher cost of cigarettes through taxes, medical insurance. Let me make my decision, just give me the inormation.

EC -173