Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -373

Accepted - Volume 6

Comment Record
Commentor Mrs. Susan F. Rogers Date/Time 2002-09-09 16:27:44
Organization Mrs. Susan F. Rogers
Category Individual

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? Much promotional speech about drugs is misleading, because the purpose of such speech is to sell drugs and increase profits for the manufacturer, NOT to educate the consumer. (For example, how does an ad stating, Claritin, for a better life. Ask you doctor. educate the consumer? It does not, it simply increases pressure on the doctor, who is perfectly capable of prescribing the medicine, when needed, without having to defend his/her position with the patient.) Speech to consumers is the issue, not speechh learned intermediaries. Consumers do not have the knowledge, motivation or time to understand whether a particular drug is right for them. They are susceptible to million-dollar ad campaigns designed to manipulate their emotions and desire to feel better at any price (or drug). It's appalling that the FDA allows direct-to-consumer advertising in this age of information overload. Such practice does NOT benefit public health, it harms it because it leads to over-prescription of such drugs.
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? See comments above for the first few questions. I believe DTC ads do NOT lead to adequate patient understanding of the potential risks associated with use of drugs - only the benefits are touted with smiling, happy people. Risk disclaimers are minimized, in tiny print and so rushed as to give the effect that they don't really matter. I believe DTC ads ARE an impediment to the ability of doctors to give optimal medical advice or prescribe optimal treatment, because they bypass the traditional doctor-patient relationship. Doesn't the FDA trust doctors to know what drugs can do and prescribe them when necessary? Let doctors do their job of protecting the public health. Drug companies advertise to increase profits, NOT to protect the public health.
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? No comment on these questions
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? No comment on these questions
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? No comment on these questions
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 comment on these questions
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, permitting speech by manufacturer, distributor, and marketer about off-label uses WOULD undermine the act's requirement that new uses must be approved by the FDA! Hello, do you have any common sense? It's because an off-label use would be a new use!! And the FDA must approve new uses! The FDA Should Have the ability to regulate speech regarding off-label use, because the FDA's job is to PROTECT THE PUBLIC HEALTH.
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, the FDA's speech-related regulations DO NOT advance the public health concerns they are designed to address. The FDA should increase, NOT DECREASE, its regulation of commercial speech regarding drugs, dietary supplements, etc. Are there other alternative approaches the FDA could pursue while still not restricting speech? I suppose if the FDA could use psychic mind methods to inject the brain of every American with accurate facts about all drugs, supplements, etc., that might work. Of course, I'm being sarcastic here. Your question is stupid. You are asking if there is another way to communicate without restricting communication. The answer is NO, of course not. Any alternative approach would have to be some form of communication, therefore it would be regard as speech! You don't have to be a lawyer to figure that one out! This question is deliberately worded to try to defend liberalizing your rules on commercial speech. As a taxpayer, I resent that. I expect the FDA to protect individuals against corporations that have no purpose for existence other than to make a profit. Corporations should NOT have the same free speech rights as individuals.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? See comments above. Go back to banning DTC ads. Prohibit drug researchers and protocol-writers from accepting funds from drug manufacturers. That's a direct conflict of interest that works against the public health. Anyone who cannot understand that on its face should not be working for the FDA. Please remember who you work for: the citizens of this country, not the corporations.




EC -373