Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -9

Accepted - Volume 1

Comment Record
Commentor Mrs. Arline Brecher Date/Time 2002-05-28 18:11:11
Organization Mrs. Arline Brecher
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? Advertising of ANY sort should be banned for prescription drugs, which by definition, are meant to be 'prescribed' by licensed physicians specifically to address a single individual and his specific health problems. Mass marketing of 'prescription drugs' is a disgusting sell-out to the pharmaceutical industry and the FDA as a government agency is suspect of collusion with an industry they are paid to regualte. Shame on the FDA!
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? Every physician has reported that because of the mass marketing of prescription drugs, patients come into the office 'demanding' a well advertised product - which is always presented in entirely euphoric terms, which has little to do with actual benefits and deficits. Shame on the FDA for allowing this.
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? Foods and dietary supplements should be free of any and all free speech restrictions. The market place is perfectly constructed to inform the buying public of the value of their products if they were left free to do so.
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? There's no science - it's all politics. Proven over and over again.
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? Let's get on with the business of keeping deadly drugs off the market - leave non-harmful supplements alone.
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? This First Ammendment issue is a red herring - the courts have decided this over and over. Why does the FDA think they are above the courts, above the law? Wipe out the FDA and we'll all be ahead.
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? Off-label use is a well established principle that has allowed physicians to discover new and beneficial uses for useful items. Get your hands OFF the docs.
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? You have no interest in the'public' welfare. Proven beyond contest your abysmal record of 'approving' deadly drug and taking years to remove them from the marketplace despite evidence
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Play by the rules - stop playing let's pretend. Leave the vitamin-taking public enjoy their good health. Stop pandering to the pharmaceutical industry. You've heard it all before.

EC -9