Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -294

Accepted - Volume 4

Comment Record
Commentor Ms. Melinda Delisle Date/Time 2002-07-30 23:08:52
Organization Ms. Melinda Delisle
Category Individual

Comments for FDA General
Questions
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? Since a drug, by its very nature, is toxic at some level of administration and has known side effects, the claims made about drugs needs to be more highly regulated. This can help prevent negative effects - even mortalities - associated with incorrect and off-label use of drugs. On the contrary, dietary supplements have few side effects, even in amounts far exceeding the recommended dosage. Thus, dietary supplements need fewer regulations regarding the discussion surrounding them. Claims made about both dietary supplements and drugs should be permitted when there are third-party scientific studies to ubstantiate the claim. Of course, because of their higher risks, pharmaceutical studies should be more closely regulated.
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 am actually rather pleased about the current regulations regarding pharmaceutical advertisements. I do not like the number of advertisements, but the requirement to list known side effects in the advertisement helps keep consumers informed. This may balance out any over-requesting from patients due to the advertisements.
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? Yes, the FDA may distinguish claims concerning foods from dietary supplements. Whole foods in their natural state are the best way to get nutrients, and consumers should be made aware that some supplements may be lacking key nutrients that work synergistically with those contained in the supplement, while whole foods most often contain a variety of nutrients necessary to proper functioning of the body. Food labels should identify the active ingredient (if a single or few specific substances are known) that supports the health claims made. The label should specify potential benefits (where third-party research suggests them), and also potential side effects when evidence exists. Claims should only be permitted when the state in which the food is sold matches the state in which there are studies supporting the claimed benefits (can't make a claim for fresh tomatoes when the study used tomato sauce, or vice versa; can't claim enefits for refined oats when study used whole oats, etc). For example, with soy products, a label might read: Consuming 25g of soy protein a day in place of some animal proteins may lower cholesterol and reduce the risk of heart attack. The phytoestrogens in soy may reduce menopausal symptoms or ____ (list other potential benefits), though too many phytoestrogens can cause ____ (list potential problems). A wide variety of whole foods helps ensure good nutrition and gives the greatest chance for good health. Consumers must be reminded that no single supplement or food contains everything needed to sustain good health and that a wide variety of whole foods is needed daily.
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? Personally, I do not believe the font size of a disclaimer makes much impact. Most people I know who are even minimally knowledgeable about natural health or nutrition do their own research in addition to what is listed on the product.
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 on lables should be specific and concise, and be supported by medical records or third-party scientific studies (though these need not be listed). Manufacturers should be required to list the rate at which certain side effects occur if it is greater than a 20% increase over the risk the general population (control group) has. Manufacturers should be given the option to list statistics for side effects as long as studies or clinical records exist to support the said rate. Some consumers seem to disregard the warning This statement has not been evaluated by the FDA on dietary 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? Claims made on product labels are known to be regulated, and thus are considered more reliable by consumers. If a claim is made in an advertisement and not on the label, many people will question it.
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? Speech regarding off-label uses of both dietary supplements and pharmaceuticals among health professionals and the general public should NOT be regulated because of the First Amendment. However, actual off-label use of any pharmaceutical should be regulated because of the high risk of side effects and unforseen problems. As an example, Cytotec (misprositol) is commonly used by some obstetricians and midwives to induce labor in spite of repeated warnings that such off-label usage is not condoned. The use of misprositol to induce labor has caused, among other problems, a number of uterine ruptures, emergency hysterectomies, and even maternal and fetal deaths that should have been prevented. Dietary supplements, on the other hand, do not have the same risk. Thus, consumers should be permitted (and encouraged) to do their own research regarding off-label claims and possible side effects. All consumers should be encouraged to do their research about any substance they take into their body, including drugs, supplements, and foods.
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 believe the requirements of pharmaceutical advertisements to disclose potential side effects as well as health claims comes closest to protecting public health. Free speech about drugs and dietary supplements should be permitted, but only if both sides are mentioned. Anytime a health claim is made, any known or theorized detrimental effects (with access to actual statistics) must also be disclosed.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Health benefit claims should be permitted on labels of nutraceuticals (and other dietary supplements) when third-party scientific studies validate said benefits.




EC -294