Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -400

Accepted - Volume 6

Comment Record
Commentor Mr. Michael Sedik Date/Time 2002-09-11 10:38:07
Organization Mr. Michael Sedik
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? The FDA's responsibility is public health. The drug industry has very special access to society not in spite of but because of the FDA. This special access should not be enhanced by affording them license to promote their profit interests as if they were providing education. Free speech is about the right to take a political/moral stand. The American people must not be further mislead by corporate criminals. The marginal, the quasi-legal, the Madison Avenue style promotions harm the health of our society. Doctors are certainly just as susceptible to advertising tricks as anyone. Any, even moderately questionable, representations of any given drug by the manufacturers should be treated as criminal fraud. The dietary supplement efforts by the FDA are, in my opinion, a dog and pony show to distract the public from the apparent fact that the FDA has been asleep at the wheel for the last twenty or more years.
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? There has not been sufficient empirical research for the FDA to take a position on direct advertising, other than to ban it entirely. This direct advertising smacks of street corner drug peddling. These direct advertisements cause mostly confusion, even among those who believe they are helpful, there is more misinformation and completely irrelevant hype than anything even approaching helpful advice.
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? Food labels must contain an accurate accounting of ingredients to any food product. The FDA should not be in the business of evaluating any medicinal benefit of food products.
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? Certainly disclaimers should have the same prominence as claims.
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? Warnings on prescription drug labels have become boilerplate. This is very much wrong. The health industry needs the same type reporting system now being proposed by the Homeland Security Administration to report terrorists. Doctors should be required to report to a central data base every occasion where a health problem arises in even the most tentative connection to a given drug. The warnings given the public must be real, must be prominent and must be driven by honest data.
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? No, why should it. The requirements of labelling should be standardised because of the handling of the medicine by health care individuals. This cannot be, in any way, a license for corporations to produce advertising flyers free of control or outside the considerations required for professionals.
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? Yes, certainly it gives corporations the wiggle room to use advertising to suggest what would be criminal to say straight out.
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? The FDA should have even greater restrictions on advertising by drug companies.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA, should go back to it's basic mission. To protect the public. There must be NO concern for the business health of any company, not the drug companies not the lobbiests.

EC -400