Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -223

Accepted - Volume 4

Comment Record
Commentor Mrs. Mavis Douglass Date/Time 2002-07-26 16:21:00
Organization Mrs. Mavis Douglass
Category Consumer Group

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? It should be legal for Dietary supplement companies to provide information to their consumers about their products. Scientific studies that have shown benefits to health should be able to be available for consumers to use when they are deciding if they want to spend the money on the particular product.
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? Instead of Dr.'s only having the information about the benefits of the drugs why can't they also have the information about the benefits of nutritional supplements so that they can give their patients a balanced optimal health plan instead of just a drug to suppress a symptom with no hope of fixing the cause of the problem?
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? Consumers may think of dietary supplements in the same way as they think of drugs if they come in a bottle in pill form like drugs do - but if the label was clear in stating that it was not a drug and could not make a claim to change or alter....etc.... as a drug can, but it was a food source, then consumers may begin to be educated on their health and responsibility for their own health. Dr.'s should have some help on that too so that they can lead us to better health instead of just masking and medicating until the patient dies.
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? They should be of equal prominence as claims.
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 will be treated differently based on the consumer's on personal attitude - that is nothing that the FDA could control
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? It should say in scientific studies and then have a site or source where consumers can go to check on it if they want to.
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? no - FDA can't control that
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? Make it all based on scientific studies that the company has to show the FDA in order to be allowed to put the claim on the bottle
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Health providers should be able to be honest with their patients and give then sources for study about nutrition and drugs - both the good and bad......

EC -223