Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -82

Accepted - Volume 1

Comment Record
Commentor Mrs. Adriana Lewis Date/Time 2002-05-31 02:52:32
Organization Mrs. Adriana Lewis
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? Yes, the side effects of drugs should be made known. Yes, promotional speech without detailing side effects is inherently misleading. I do not believe there should be a difference between intermediaries or consumers. Many times the tests that prooved the drug effective are flawed in the sense that there is too much of a vested interest in the results and a company can do many tests and pick the one they want. This is not truly scientific because then they can control the results by selecting certain types of patients to experiment on.
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? I have a major disagreement with promoting medication for a disease. Given the power of advertising, if you press home the point that you could be suffering from a certain disease, it is certainly possible for the mind to concentrate and then create or certainly contribute to the disease. Currently in America, where we have the most advertising of drugs, we also have the most drugs prescribed in the world and more diseases than any other country. How is it that we have so many more add kids than any other country??? Also doctors are people in a position of authority and many believe the voice of authority.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? I think that the FDA should allow data to be freely disseminated about foods and vitamins. There should of course be a disclaimer. But the data should be allowed to be presented. certainly foods and supplements do not have the inherent danger of drugs which kill thousands of people each year.
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? Yes.
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? Just make sure that the data is clear. That the source of the data is made available and that the data is in simple enough language and the unusual terms are defined so the person reading the data can effectively evaluate the info.
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? I think a label should include both the benefits and the side effects if any.
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? What makes the FDA the senior source of product control, when the members of the FDA are recipients of stock and various benefits or on the boards of drug companies? How can a vitamin company compete with the deep pockets and the lobbyists of the pharmaceutical industry.
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? In Europe, when a person receives a medication, they get the same info that the doctor receives with the benefits and the side effects. In America, the patient has to go to the PDR and just usually relies on the word of the doctor. More information. Clear information. Possible side effects.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes. Require that Drug companies indicate the side effects of their drugs in full detail. With vitamins and other supplements, allow full information about the research and allow the consumer to make an informed decision.

EC -82