Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -269

Accepted - Volume 4

Comment Record
Commentor Ms. Katrina Vaillancourt Date/Time 2002-07-29 17:03:55
Organization Ms. Katrina Vaillancourt
Category Consumer Group

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 understand the need to protect the public from misleading statements regarding health benefits. However, there are some duh pieces of information. We know that certain nutrients are good for health skin, hair, eyes, heart, bone, etc. This is scientifically founded to be true. If the scientific data is there to back it up, it should be allowed on the label. If you don't feel that is enough, require companies to add the footnote indicating the scientific articles which back up the health statements. The FDA could assist here by creating a website that keeps a library on the health benefits of various nutritional, and herbal supplementation, allowing companies to submit their studies for review. This would be a great service to the public as it is already obvious that proper nutrition is our best defense against the rapidly growing rate of the top diseases and conditions leading to death.
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 advertisements on TV for pharmaceuticals are hugely misleading- playing on people's emotions to pursuade them to purchase drugs which are proven toxic. (You must kill rats with a drug before you can show it's effective dose). Doctors do not have the time to deal with a patients request for these drugs, and if a patient wants it bad enough, they'll just choose a doctor who will write them a prescription. It is good for patients to know they have resources, but these advertisements are selling feel good with your family in your sunny garden with some kind of antihistamine or sexual enhancement tied in. These drugs are proven to increase sickness over time. I vote health through education- not pursuasion.
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? The administrative record must contain evidence that the scientific studies which back the health claim are invalid. Statements on labeling must accurately reflect the results of the studies backing them up. Consumers should be encouraged to go to the website there the study is published to do research on their own. (preferably a site sponsored by the FDA or an organization like the NIH) At this point, with all the special labelling on foods, I see no basis to believe that consumers would look at dietary supplements differently than packaged foods. What does not seem to be understood by consumers is that herbs are not essential nutrients and need to be regarded in a different way than essential nutrition.
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? small print is fine. Consumers know to look for that.
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? If there is any known negative side effects, that should also be on the label. The side effects should indicate the amount of nutrient or herb at which the negative side effect may be seen and in what percent of the population this is true. Also, now that most companies have websites, all the labelling information should be included in product information and nutritional listings on the websites.
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? don't know.
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? Once again... where's the science to back up the claims?
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? I am not familiar enough with the current regulations to answer this.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? same as above




EC -269