Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -97

Accepted - Volume 2

Comment Record
Commentor Dr. Anthony Herbst Date/Time 2002-06-01 16:28:05
Organization University of Texas
Category Academic

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? Under our constitution there should be no a priori censorship. Open discussion is healthy for finding the TRUTH, which is what everyone should seek. I am very troubled by the notion that there are different categories of free speech and that speech about drugs or health issues should be regulated/censored. The very idea is appalling.
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? Direct to consumer advertising should be no problem as long as the statements made are truthful and disclose fully both the positive and the negative characteristics. Instead of censoring I would like to see the FDA embark on an educational program to make consumers aware of drug/health matters and teach them how to be informed citizens and health professional clients.
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 only assure the purity of the goods sold, not make judgements and censor claims backed by scientific research and published papers. We do not need Big Brother looking after every aspect of our lives. And if consumer safety is the real issue, how about FDA taking a more proactive interest in conventional foods contaminated by pesticide residues and other chemicals?
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 see a need for disclaimers. Aggrieved consumers have remedies in the courts that should ensure vendors reveal as much as prudence dictates they should.
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? Warnings per se are virtually worthless except possibly in cases of products that pose immediate and drastic health hazards, such as pesticides,
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? There should be absolutely no restriction of truthful claims. This means there should be no arbitrary and capricious distinction. The First Amendment is pretty clear.
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? The FDA far exceeds what most Americans want of it. We want to know only that the purity of what we purchase is as advertised. We do not want arbitrary controls and censorship. The glacial pace of FDA approval for off-label uses, and the monumental screw-ups with drugs approved for use that later prove to have serious, life-threatening side effects, suggests that the FDA should return to its original mandate.
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! They promote the interests of the major drug companies. Educate the public on how to be intelligent consumers. And don't be the handmaiden of the drug industry.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes. Stop ignoring the First Amendment! Follow court orders to desist from violating citizen rights.

EC -97