Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -147

Accepted - Volume 2

Comment Record
Commentor Dr. John Trowbridge Date/Time 2002-07-10 17:53:11
Organization LIFE CELEBRATING HEALTH Assn
Category Health Professional

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? Drugs are unnatural components with effects in human systems that are not readily extrapolated, in contrast to nutritional items that have been in the human diet (albeit in varying amounts) for millennia. Drug warnings should assume that they are incomplete. Drug speech to learned intermediaries can be more technical than to consumers because consumers lack the background and training to analyze claims and they lack a dispassionate disinterest in a particular product: consumers are searching for results and will cling to hype because of hope.
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? Allowing wide-open advertising by industry to consumers certainly holds the prospect of over-prescribing, but I have no clear data. Advertising that promoted following a health professional's advice and complying with appropriate follow-up testing and continual monitoring would be in a consumer's best interest. Current advertising to consumers downplays the actual risks. FDA approval of OTC availability of several groups of drugs (steroids, NSAIDs, gastric acidity reducers) most certainly leads to unintentional overuse and deliberate misuse by consumers, greatly risking their safety.
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 FDA should stay OUT of regulating claims whereever possible, requiring simply this warning on EVERY nutritional supplement and food making any claim: This claim has NOT been evaluated and approved by the Food and Drug Administration. Caveat emptor.
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? Disclaimers have the same weight as claims and 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? I don't have evidence, but I'd argue for having potentially harmful items labelled as The Food and Drug Administration has NOT evaluated this product with regard to safety or effectiveness when used in any dosage or program. Caveat emptor.
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? The government should exercise MINIMAL control over claims made -- the key is to let the consumer know whether claims have been evaluated and whether safety or effectiveness has been evaluated and let the marketplace produce sufficient evidence without arbitrary controls.
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? Once again: The Food and Drug Administration has NOT evaluated this product with regard to safety or effectiveness when used in any dosage or program outside the scope of approved labelled indications.
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? Once again: The Food and Drug Administration has NOT evaluated this product with regard to safety or effectiveness when used in any dosage or program outside the scope of approved labelled indications. AND This claim has NOT been evaluated and approved by the Food and Drug Administration.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Absolutely. Get OUT of the business of trying to regulate every nit-picky -- especially in light of FDA approval for OTC use of very dangerous drugs (I killed a patient with Naprosyn in 1980 -- now Aleve is available OTC with NO limitations) -- and simply place consumer warnings that the FDA has not evaluated or not approved the claims or recommended use. Otherwise, eventually we're going to have the FDA requiring a choking hazard warning on bread crumbs and croutons packages ..... and eventually a choking hazard on bread labels, if this product is toasted and cut into small squares.




EC -147