Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -59

Accepted - Volume 1

Comment Record
Commentor Mr. Gary Sandman Date/Time 2002-05-29 12:26:22
Organization Integrative Medicine
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? As long as the law is not broken and the claims are not false or misleading - the consumer is more educated than you give them credit
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? it is obvious that a prescription drug is too complex an issue to sell directly to the consumer- why allow the advertising of it to the consumer - so that the consumer can tell the doctor what to do -? this is rediculus - the cost of advertising to the public should not be a business expense for drug companies - and I would go further if possible to restrict the advertising directly to the consumer - if that were legal
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 label is the place to make a claim based on evidence - there is a difference in buying a supllement than a food item - the consumer is more educated when buying a supplement and can decide from other sources the benefits of a supplement -
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? declaimers should be smaller type and not sinister in nature - when no harm has been found they are not necessary
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? tell the truth
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? tell the truth
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? yes do your job for the people not drug companies - place restrictions on the big money to sell drugs through consumers make it easier to verify the benefits of natural products- protect the investments of those investing in natural products and make it affordable to prove effectiveness with cooperative research on natural products -
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Stop making it so hard to use and understand natural food and supplements for prevention and therapeutic use - open your eyes to the thousands of years natural products have been used to help make us healthy - GRAS products need to be easily listed so the public knows what is safe - it also seems to many people the the FDA is prejudice to any natural substance or supplement - the over reaction of potential harm from any natural product - the contamination issue is a problem of natural products - but you tend to persecute the product that is contaminated and not the process- the FDA over-reacted with ephedera when very few deaths occured -consumer dis-information the FDA created by releasing the raw data from the complaints file without first determining it's validity - youclaim to be working for the publics best interest with a basis toward drug companies and against natural products - why not try cleaning house and removing the credibility issues and making clearer inhouse rules to stop the continued conflict of interest issues that your reviewers have - you do not thave the publics trust - why don't you try honoring that before you wrap yourself in the first amendment crusade




EC -59