Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -112

Accepted - Volume 2

Comment Record
Commentor Mr. Dean von Germeten Date/Time 2002-06-05 02:20:40
Organization Mr. Dean von Germeten
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? The FDA has no authority to regulate speech based upon the First Ammendment which prohibits such regulation. Misleading statements made by drug companies or anyone else are the perview of the claimants filing suit, and the courts. The FDA is perfectly free to express its opinions however, for education purposes, but should be subject to lawsuits in the event the FDA's position is found to be untruthful or biased to special interests.
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? No and no. The problem is you gentlemen have no possible means to be objective because your education acts as a filter only permitting certain concepts into your awareness, whereas reality isn't about filters. Promoting drugs doesn't encourage individual responsibility or self-education. Your agency should be about providing best information from ALL sources, not just those special interests who pay you money and whose interests you serve (AMA, pharmaceutical lobby, etc.)
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? No. Foods contain vitamins, minerals and enzymes and as components of food you have no legal right or jurisdiction to regulate them. Anyone should be permitted to quote scientific literature without limit to support health claims.
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? It would be helpful for the public to know that no product can guarantee results in any particular case, but that is a liability issue sellers are well aware of and don't need FDA high-handedness to cover.
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? Scientific literature supplies ample information what might be considered an overdose of a given substance. A seller of potentially harmful substances for liability reasons might include this voluntarily.
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? NONE and NO.
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? Nowhere in the Constitution is the government given power to regulate substances. Your agency has overstepped its Constitutional Authority but you are so comfortable that you don't see it as an encroachment and even need to ask the question.
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 it does not advance the public interest. FDA should become an educational body and stop regulating, because biased minds will always regulate unjustly.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Stop regulating, stop costing everyone money, stop restricting new discoveries, research and experimentation, STOP KILLING PEOPLE by restricting their access to substances and therapies you don't happen to like or approve! Even shamanism works in some cultures! The public is smart enough to deal with snake-oil salesmen if you let them. Discrimination is a skill that only develops with practice. You cannot protect a teenager forever from experiencing the world, and you shouldn't try to protect the human mind from discerning between good and evil. If you want to assist the public in discerning, that is a noble purpose and would earn your agency more respect than the current fascism.

EC -112