Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -93

Accepted - Volume 2

Comment Record
Commentor Ms. Diana Marlene Austring Date/Time 2002-06-01 08:16:21
Organization Independent USANA Associate
Category Dietary Supplement Industry

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? Anything that may have severe side-effects that can be deleterious to health should be regulated, but the potential health benefits of products should also be available. There has never been a double-blind, placebo-controlled scientific study to determine that cigarette smoking causes cancer, yet it was recognised epidemiologically and has been accepted as fact. Why cannot the epidemiologically indicated health benefits of high-quality, pharmaceutical-grade supplements be promoted?
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? I'm appalled at the power the huge drug companies have. There have been recent reporting of breaches going back over several years which are only being made public now, and they seem to be done with impunity...
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? This is a real hornet's nest since any claims about, for instance, the vitamin-C content of oranges cannot be valid. It's been proven that the nutritional content of any particular food product depends on the soil in which that product was grown: if the soil was deficient (as most is), the produce will be deficient. On the other hand, with companies that use pharmaceutical Good Manufacturing Practices, you are guaranteed that what's on the label is no more and no less than what's in the product.
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? I believe that any claims (positive or negative) should be given equal prominence.
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? Clear communication... Advise people to seek guidance if they aren't sure.
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? Labels must have disclaimers and proven (or even suspected) side-effects listed, and I tend to think ads should have them, too.
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? There should be strong scientific backing for any claims made; if new evidence comes to light, it should be added to the products' approved 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 think there are lots of ads for drugs that are blatant in their hype (and miniscule in their unreadable fine print) while responsible, ethical supplement companies aren't allowed to give people the evidence which strongly suggests or proves health benefits.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think that the FDA should be doing everything in its power to encourage people to be proactive about their health and practice prevention of disease rather than depend on treatments for disease. Put a fence at the top of the cliff rather than an ambulance at the bottom.




EC -93