Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -339

Accepted - Volume 4

Comment Record
Commentor Ms. Vicki Robin Date/Time 2002-09-05 16:48:43
Organization Ms. Vicki Robin
Category Association

Comments for FDA General
Questions
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? I believe that advertising drugs is increasing the demand for unnecessary drugs, driving up the cost of health care for all, compromising the health of those who take useless drugs and fouling our water supply as undigested pills get flushed with feces and urine down the toilet. It does not serve the public who can either find a trusted doctor to interpret what is useful, manage drug interactions, etc. or can go on the web easily to research their ailment and the treatments available. Drug advertising is mental pollution leading to environmental pollution and moral degradation.
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? Any government approach that does not limit drug company advertising is excessively laissez faire and diminishes the power of our highly informed, educated and balanced medical professionals as well as increase the dependancy of the general public on a pill for every ache approach to the rigors of living. WE are an overmedicated society. It is costing us millions. The government is supposed to be of, by and for the people not the corporations!
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 believe that consumers still trust the FDA, and if food supplements are not approved by the FDA, that makes a difference to us. We know we must inform ourselves and take risks - financial and health - in purchasing supplements. Since humans have inhabited this earth, food has been medicine, so public education on the health benefits of certain foods IS the FDA's role.
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? if disclaimers allow advertisers to keep advertising, then forget disclaimers, just NO ADVERTISING
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? Consumers listen to trusted friends and professionals - that's why doctors nurses and nutrituionists should be out there dispensing good information at low cost.
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? not familiar with the law.
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? This is not really a free speech issue because corporations aren't people, no matter what the history of the law is for the last century. people speak. corporations are mute. there can be no speech without responsibility, and corporate charters protect the speech-capable people within corporations from responsibiility plus corporations have more resources for legal action than individuals and so can win their case even if they are damaging the public good.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think my opinions by now are clear.




EC -339