Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -228

Accepted - Volume 4

Comment Record
Commentor Mrs. Rebecca Arrington Date/Time 2002-07-27 12:41:24
Organization Mrs. Rebecca Arrington
Category Health Professional

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? Speech for drugs and dietary supplements should clearly describe documented scientific benefits and side affects. The choice to use the drug or the supplement should be the inherent right of the individual taking the drug or the supplement.
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? Promotion of new prescription drugs has increased the cost of medical care. Education of the consumer is very important - but the promotion of high cost prescription drugs over other qualified prescriptions only puts money in the coffers of the pharmaceutical companies.
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? If presented with clearly described scientific facts consumers can make excellent choices for their own health needs. An excellent statement would be: Consumption of antioxidant vitamins in the amounts contained in this product may reduce the risk of certain kinds of cancer.
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 be in the literature provided in the packaging of the supplement or drug. It should direct consumers to web sites that contain scientific information regarding the product.
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? The label should clearly state that normal levels are XXX and toxic levels are found at XXXX
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? Both advertisements and labels should clearly state the benefit of the product and the side effects of the products. Consumers should be able to make their own choices without government or big business intervention.
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? If there is scientific data available about off-label uses the manufacturer, distributor, and the marketer should be able to clearly state the off label benefits of their products. Consumers should be able to make their own choices without government intervention. Many times it is big busines monetary issues that cause decisions to be made and not the actual prevention of diseases.
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? Promotion of scientific data, both nutraceutical & pharmaceutical data, should be promoted. The FDA should not hinder promotion of a product that enhances good health and prevents diseases unless there is clear scientific data that the product is harmful to the majority of the people.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? If pharmaceutical companies can advertise the health benefits of their products, nutraceutical companies should also be able to advertise the health benefits of their products. Scientific studies backing the products should be filed with the FDA, and with a central web site with all products listed for both consumers and physicians to peruse.

EC -228