Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -107

Accepted - Volume 2

Comment Record
Commentor Mr. Robin Alexander Date/Time 2002-06-03 12:09:26
Organization Mr. Robin Alexander
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? Durgs and dietary supplements should be held to different standards. The FDA should regulate drugs but should not regulate dietary supplements. The rules for food are adequate to regulate supplements. It is not necessary for the FDA to require beef, pork, and potatoes to have a lable that says The FDA has not evaluated the safety or effacy of this food. The evidentiary basis for the distinction is common knowledge.
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 believe that the direct-to-comsumer advertisments by drug manufacturers are counter-productive. They should be stopped.
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 of the dietary supplements are backed by research of some type. Research is usually more limited in scope due to the lower revenue generated by dietary supplements. But the research is being done and the results show that some, if not most, of the supplements are effective. They are not drugs and mostly do not replace drugs. There are some suppliments that are more effective than drugs. But they are not a direct replacement for drugs and are not in direct competition with 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? Disclaimers are unnecessary and should not be required. Social science research is very expensive and cannot be funded by the supplement industry. (Don't bother to be nice to the supplement industry, you won't be able to get a high paying job in the supplement insustry after your tour of duty at the FDA.) It is likely that the effect of a warning on the label of a supplement that says The FDA has not evaluated the truth of claims concerning this product will not make the public safer or more informed. It probably will prevent some people from using the supplement when there is no scientific reason to not use the product. Some people suspect that the FDA does not adequately regulate the drug manufactorers and spends more time promoting their best interest.
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? The question should be, Are warnings required? I think not in the case of supplements.
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? No one should have a right to be untruthful. But freedom should not be restricted in one segment of the economy to benefit another segment of the economy. It is true that there is not enough room on drug and supplement labels to fully disclose the revalent reaearch and possible side effects, and FDA approval or non-evluation, but to apply a blanket disclaimer is the same as restricting comercial speach.
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? Supplements are not drugs. Do not apply the same standards to both. You don't apply the same standards to foods and to drugs. Supplements are as natural as foods (with some 80 percent of the supermarket full of manuactured food products that are not found anywhere in nature--corn flakes do not grow on corn plants, its hard to remeber that there are some natural foods in the supermarket) and do not requre the same high standards that drugs must be held to.
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? I do not believe it should be the FDA's purpose to clasify supplements as drugs when it is obvious to all that they are more like foods.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should stop requiring dietary supplement manufacturers to put the FDA disclaimer on their labels. Also, the FDA should allow dietary supplement manufacturers to cite clenical and scientific studies that have been done on the herb or extract that is within the labeled container.

EC -107