Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -37

Accepted - Volume 1

Comment Record
Commentor Dr. Stanley Wiggins Date/Time 2002-05-29 00:00:50
Organization U.S.A. Citizen
Category Individual

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? FDA should not be allowed to restrict the language on vitamins and minerals that have clearly proven to aid in resupplying the immune system for the body to heal itself
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 believe that prescription drugs have NO business being advertised directly to the consumer since drugs are illegal without a prescription.Informing the general public, including the dangerous side effects, about a controlled drug should be allowed via a responsible licenced practising doctor or pharmacist.
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? There is NO vitamin or mineral that is not good for the body if properly prepared and used in proper dosage. Certain supplements should disclose when it is necessary to take with other supplements to get the best assimulation.
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 do not believe there should be any disclaimer posted. A reference should be made to where a consumer can read the research on the supplement inquestion. Also MAXIMUM dosage.
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? There is adequate information available. No other warnings are necessary EXCEPT for prescription drugs
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? Eliminate advertising to the general public on prescription drugs. Vitamins and minerals are not dangerous for any one that can read and for those that cannot read won't be using the supplements, therefore the FDA should let the supplement industry supply to the consumer with the vital vitamins and minerals that have been vastly depleted from our soil and therefore cannot be supplied through fruits and vegetables.
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? Why must the FDA approve nutrients our bodies require to sustain good health?
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? No, FDA does not advance the concerns they are designed to address. The FDA could work more closely with alternative organizations and coordinate new findings through resereach to develop safe alternatives to subscription drugs
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Leave The First Amendment Alone

EC -37