Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -224

Accepted - Volume 4

Comment Record
Commentor Mrs. Beth M. Davis Date/Time 2002-07-26 16:29:11
Organization Mrs. Beth M. Davis
Category Dietary Supplement Industry

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? It is imperative that the people retain the Constitutional right to freedom of choice and speech regarding personal health. We are guaranteed this right under the Constitution and no agency or commission can infringe on that right. The standard must be that we communicate accurate and documented information.
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 do not wish to sound cynical, nor do I desire to risk that the Food and Drug Administration (FDA) close its ears to my comments. Nevertheless, may I respectfully suggest that the FDA is hardly in a position to render a neutral judgment in any issue involving prescription drugs and natural food supplements or alternative health therapy. First, the FDA and all governmental representatives must “get out of bed” with the drug and insurance industries and open the avenue for researchers to freely communicate their findings with the public and compete for research funding. Subsequently, caveat emptor—let the buyer beware. Without the free communication of information, the buyer has no opportunity to “be aware.”
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? First, let the FDA inform the public about the truth regarding the difference between whole, natural food products and synthetic counterfeits such as ascorbic acid versus vitamin C. It doesn't take a molecular biologist or organic chemist to see the difference between these two compounds.
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 read labels and am a reasonably intelligent person. I have also read the fact sheets which accompany prescription drugs, many of which warn that the approved drug side-effects may be equal to or worse than the condition it is intended to treat.
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? Most people follow the advise of a friend or medical professional. Unfortunately, the latter is only allowed to study and prescribe drugs.
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? What is wrong with holding the advertisers and labelers legally responsible for the claims they make? Don't we already have a system of justice that should protect the public against false claims?
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? What is wrong with holding the advertisers and labelers legally responsible for the claims they make? Don't we already have a system of justice that should protect the public against false claims?
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? Will the FDA presume to tell the public what foods they must eat, the time of day to eat them, the amount and for what reason? Where is the reasonable man in this issue?
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The First Amendment, the first of ten amendments added to the Constitution in 1791, was intended to limit the power of the federal government. Note the word limit, not expand the government.

EC -224