Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -149

Accepted - Volume 2

Comment Record
Commentor Dr. Ray Hayes Date/Time 2002-07-13 20:11:57
Organization Dr. Ray H. Hayes
Category Health Professional

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? Prescription drugs must perform as advertised, whereas dietary supplements, as I understand the courts, is off limits to FDA. I believe the FDA has a legitimate requirement that dietary supplements contain what the label says, eg. if it says 1000mg Vitamin C, then it should have 1000 mg., and the FDA should prosecute contents inaccuracy as fraudulent advertising.
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? The pharmaceutical industry promotes its goods by giving samples, food, trips, etc. to healthcare providers. With enough samples, food, and trips--the promoted drug becomes widely used. These promotions frequently mean more to successful drug sales than drug effectiveness.
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? Many consumers are more educated about supplements than many health care providers. Thousands of sources of information are readily available to the individual. FDA has a monumental job uncovering prescription drugs dispensed by the medical community which kills thousands yearly. Please don't waste time on supplements which very seldom kill. FDA will save more lives per dollar spent by close followup of newly approved drugs.
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? Publicly advertised prescription drugs should have disclaimers in same or larger type and be given equal prominence with claims. In regard to food supplements, disclaimers are a waste of time and are often perceived as FDA self promotion. Your time insuring the labeled contents and actual contents are accurate is a great service to the public. Individuals are helpless against this type of fraud in supplementation, and your efforts would certainly help citizens and would be perceived as helpful, rather than intrusive of personal rights.
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? Consumers have a weapon much more deadly than the FDA for harmful substances. It is tort law. Remember John Mansfield, Dalcon Shield, and leaking breast implants! Compare the punishment to these companies to those pharmaceutical industries fined by the FDA. How many pharmaceutical giants have gone out of business from FDA fines?
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? First Amendment trumps here.
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? Allowing speech about Off-Label uses is the essence of America. eg, Many dentists know that 20mg dosage doxycycline utilized not as an antibiotic, but as a collagenase inhibitor for periodontal disease also helps with arthritis. How? --when patients with arthritis begin telling you their arthritis is getting better since they have been on the gum medicine and this revelation occurs unsolicited over and over---it doesn't take rocket science or 10 million dollars to see it can help -- and it doesn't harm the periodontal patient to have a beneficial side effect. I find it inappropriate that I can't tell a patient with arthritis that low dose doxycycline may offer them relief until (if ever) the research is done to show this is effective--and--who is going to do 10 million dollars research on an drug with an expired patent?
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? For prescription drugs, speech related regulations are strongly needed to protect the public, but FDA's speech-regulations do NOT advance the public health concerns they are designed to address in relations to food supplements. FDA required statements are effective when required on known toxic substances, but when stated as --this product or information has not been reviewed by the FDA-- it becomes more of a joke among the public than helpful information. Jokes of this nature detract from the FDA and demean its importance.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Fighting health care providers and losing in court tarnishes the reputation of the FDA Each time you lose, it takes away from your credibility. Futhermore when you lose and ignore the court order, it fortells a day that congress will reduce your power. The public needs you-- its just that they want you to protect them in ways they have no ability to help themselves eg. Pharmaceuticals where the public has no knowledge. However, individuals can today reach a great level of competence by using the internet, searching medline, PDR, and thousands of other sources to identify supplements they want---but they have no way of knowing that what they ordered and paid for is really what is in the bottle. This is frightenly true for items coming from developing nations where DDT, and other toxic materials are legally used in producing foodstuffs, and supplements. Thank you for this opportunity to express my comments.

EC -149