Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -436

Accepted - Volume 6

Comment Record
Commentor Ms. Tabitha Metreger Date/Time 2002-09-17 20:56:59
Organization Ms. Tabitha Metreger
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? The so called speech you are referring to is, in actuality, manipulation which is carefully crafted by the companies and the highly trained psychologists, sociologists and marketers employed by them to do anything in their power to get doctors to prescribe their drugs and consumers to demand them. Drug companies are using the same manipulative marketing techniques to sell prescription medications that are used to sell shampoo! Whether or not a patient should take a medication should depend solely on the medical expertise of the doctor and the patient's particular symptoms. Nothing else!
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? The direct-to-consumer advertising now being implemented by the pharmaceutical companies is anything but informative. It is pure and simple manipulation, as is most advertising these days. It plays on the fears and the hopes of the consumer rather than giving them all the information they need to make an educated decision on their need for the medication.
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 do not believe any claims should be made on any food or supplement. They should be allowed to state (accurately) what they contain, but no more. Consumers should not be eating a certain food or taking a certain supplement merely because the advertising on the package says it will help them. The decision should be made based on knowledge the consumer has gathered from his or her own research and discussions with doctor or nutritionist.
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? Disclaimers should definitely be in at least the same size type and be of equal prominence. To have it any smaller would be misleading and manipulative!!!
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 should be prominent and blunt. Look at cigarette warnings on European cigarettes as an example--they are much more prominent than our own and are not confusing in the least.
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? We must stop referring to advertising and packaging as speech. This is simply ridiculous. Is this really what our forefathers had in mind when they spoke of freedom of speech--some vague entity made up of not one individual, but many, all of whom have a job to increase the profits of the corporation. And so, in order to do so, they hire social scientists and spend billions of dollars on research to figure out how to manipulate children and adults alike to buy! buy! buy! Does the First Amendment really protect this manipulative advertising under freedom of speech? I don't think so!
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 my opinion, restrictions on advertising and packaging are not restrictions on speech!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Please cease protecting so-called commercial speech as if it is the same as an individual's speech. Corporations are not individuals and the vast majority of Americans do not have the wealth and power that the corporations do to have their speech heard. This results in a totally unfair disadvantage for the American individual. Is it time we stopped putting the rights of the corporation above the rights of the individual!

EC -436