Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -252

Accepted - Volume 4

Comment Record
Commentor Mrs. Helen James Date/Time 2002-07-29 10:26:42
Organization Mrs. Helen James
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? Free speech about drugs must be regulated more comprehensively than about dietary supplements given the far greater potency of drugs and the enormously greater harm done by drugs vs. supplements. One need only look at the statistics about deaths caused by properly used prescription drugs to see that they are far more dangerous than vitamins, for example. You cannot rely on data provided solely by pharmaceutical companies to support their claims. Independent studies must be conducted and the public advised of the results. Certain promotional speech about drugs is unquestionably misleading and the consuming public must be told the entire story. Europe seems to be far ahead of the US in that regard. Even learned intermediaries must be given all the information- many physicians are easily led by pharmaceutical company representatives into prescribing the drug of the week without having any idea about safety issues.
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? Your current position on direct-to-consumer advertising is not consistent with empirical research when it comes to dietary supplements. In the US, this research is not being done as there isn't any money to be made by doing it. Europe, on the other hand, has extensively researched many dietary supplements and the FDA must open its eyes and look at studies generated outside of this country! Since pharmaceutical companies are permitted to advertise their drugs at will, dietary supplement manufacturers must be allowed to do the same thing and make claims about their products as well. If studies conducted out of the US can support the claims of the supplement manufacturers, then FDA must consider them. The argument that patients may delay getting needed medical treatment by trying supplements first, is ridiculous. Many people have improved their health and have actually been able to discontinue their use of toxic pharmaceuticals by utilizing supplements.
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? Since most dietary supplements can be traced to foods, there should be little regulatory differentiation. To claim, for instance, that an orange contains Vitamin C and to add that Vitamin C may boost the immune system, the health of blood vessels, and help the eye to remain healthy is not misleading at all. People need to know this and should be made aware of it. To make a similar claim for Vitamin C tablets should be fine as well. The best way for FDA to deal with this is to review studies from around the world, and not just in the US, about the effects on the body of various foods and supplements. There is no shame in directing a consumer to a non-US information source.
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? Claims and disclaimers should be specified in the same size type.
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? Regarding pharmaceutical drugs, patients must be told ALL the possible consequences and then be allowed to make an educated decision. They should also be told that for a specific condition there may be dietary supplement or food alternatives that will help. An example is using glucosamine and chondroitin sulfates as an alternative to Vioxx for arthritic inflammation. I know many people who have achieved great improvement in that fashion, and doctors should be able to tell this to patients while explaining that using Vioxx can be far more dangerous.
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? Advertising and labelling claims should be consistent with each other.
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? Discussion of off-label uses should be permitted if supporting studies are available. As mentioned before, FDA must look to studies originating out of the US for this to be viable. Consumers need to be given the whole story and be allowed to make an educated decision based on that.
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? The current speech related regulations are ridiculous. Supplement manufacturers make claims and then state that FDA hasn't put their blessing on the claims. Let supplement manufacturers state the full truth, such as: this product has not been evaluated in the US, but studies in Germany have shown that.... Manufacturers should provide consumers with copies of the studies, if requested.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? All the regulations, etc. should be changed to allow consumers to evaluate the issues by considering all currently available information. Example: Linus Pauling advocated high dose Vitamin C as being beneficial for many conditions. Consumers should be told about his work so they can evaluate it and make their own decision as to how much to take.

EC -252