Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -233

Accepted - Volume 4

Comment Record
Commentor Ms. Jan Barosh Date/Time 2002-07-27 18:44:34
Organization Ms. Jan Barosh
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? Yes, my understanding is that drugs must go through several phases of testing because they are inherently toxic. Therefore the testing determines appropriate amounts of the drug which is allowed to be administered to patients. I believe that certain promotional speeches about drugs must comply with FDA requirements. I also believe the general public should be educated as to what those requirements are and why they are necessary.
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 a lot of the general public are mislead in their understanding of what FDA regulation is. I believe that many people feel that if it is FDA approved, it is safe. I believe the people should be educated in the parameters of safety as FDA approval implies and that it is up to the public to educate themselves of positives and negatives of using drugs, biologicals, etc. whether or not they are FDA approved. I believe the general population should have adequate access to correct information on what FDA approval is and what it means (positive and negative) if a product is approved or not approved by the FDA.
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? I believe that any food that has been altered in any way (gmo, additives, extracts, etc) should be labeled as to what has been done to the food product. I believe that dietary supplements should not be withheld from consumers. I do believe that dietary supplements should meet standards of product quality (and specific ingredient quantity MUST match label claims) and that consumers must have access to information to educate themselves as to benefits or problems they may encounter with ingesting dietary supplements. In otherwords make sure the consumers have all they information they need to make a good decision for themselves, but do not absolve them of responsibility.
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? Same size or at least a size that is easily read by it's target market. That includes background and print color to ensure readability.
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? I don't know if research can determine satisfactorily as to what the risks are (ie 3% of people who take this product experience _____ ). If it is possible, I think that wouold be a warning that could help people make a decision as to their own risk/benefit of consuming a product.
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? No opinion at this time.
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 definite opinion at this time.

EC -233