Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -167

Accepted - Volume 4

Comment Record
Commentor Mrs. Ruth Oystol Date/Time 2002-07-25 14:16:04
Organization Mrs. Ruth Oystol
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? It seems to me that there is certain promotional speech about drugs that is inherently misleading. Drugs don't cure anything. The BODY cures itself. Drugs can help kill some disease, but Drugs have a LD-50 and so are all poison & have side effects. It seems that TRUTH about Drugs needs to be required. And TRUTH about Dietary Supplements also needs to be allowed to be spoken and written. The Dietary Supplement Health and Education Act of 1994 needs to be protected and even improved upon. Both drug companies and dietary supplement companies need to be held accountable. Dietary supplement companies need to be allowed to speak out about their research without being accused of making drug claims. Dietary supplements are their own category, and most do not have a LD-50 and many have no toxicity at all and so are much safer than drugs in the support of health.
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? Advertisements of prescription drugs seem misleading, and people who are desparate for health then self-diagnose and pressure their doctor to over-prescribe. However, education (with TRUTH) of the consumer is important. People are not stupid, and doctors and pharmaceutical companies are not gods. Most patients do not have an adequate understanding of the potential risks associated with the use of drugs. The FDA is needed to keep a balance. The first amendment is after TRUTH being allowed to be spoken. It is important that the FDA not have power to gag the TRUTH. However, the FDA should be able to determine when TRUTH is not spoken, and to bring that to light to the public and the food, supplement, and drug industries.
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? Not all foods contain the nutrients they should have because of poor soil or green harvest, etc. Dietary supplements that are manufactured by good companies who use the latest in scientific developments to produce their supplements, have the real nutrients in them. Therefore, foods and dietary supplements should have different regulations. DSHEA gave dietary supplement manufacturers the ability to educate consumers about scientific research that showed how various nutrients can effect a person's health. That ability is VERY IMPORTANT TO PROTECT! TRUTH about nutrients is essential, and does not need the same protection as drugs do. Drugs are much more dangerous. There is MUCH scientific research on dietary supplements and how they support health. The FDA needs to require standardization and stabilization of supplements -- and qualify control -- to assure that the end product of a dietary supplement has the nutrients it says it has in the final product. To say that a statement has not been evaluated by the FDA seems to be misleading when the FDA's role is not to evaluate but rather to regulate standards and to hold companies to be TRUTHFUL. The FDA is not a scientific research company and does not determine what treatments or nutrients help what diseases.
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 should be required to be in the same size or type along side the claims -- if the disclaimers are based on scientific research and are not just legal jargon. If the disclaimer is a warning and is serious, it should be in LARGER size. Disclaimers should be different for the various categories of Foods, Drugs, or Dietary Supplements.
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 warnings need to be based on science -- not on legislation that says what you can or can't say. If something has been shown to have certain side-effects, it is important to say so. Consumers disregard confusing warnings & warnings that are too technical.
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? Both advertisements and labels need to have claims that are TRUE, and the Government needs to require such truth in both.
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? There are hundreds of scientific studies on dietary supplements that are too numerous to get all the information on a small label. Manufacturers, Distributors, and Marketers need freedom to speak about what they know. It is up to the consumer to validate information which is possible on the web. Permitting speech by manufacturer, distributor, and marketer about off-label uses does not undermine the act's requirement that new uses must be approved by the FDA. It is too large a task for the FDA to keep up with all new uses that people discover work for them. When it is not in writing, people need to be empowered to get educated and to come to their own conclusions about dietary supplements. If it is drugs that are being talked about, then a presription should be required anyway, and people are protected from mis-use. Drugs have more need of protection because of their higher toxicity.
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? Not always. With dietary supplements, the FDA actually keeps truth from being spoken at times. The public is actually caused to think that drugs are much safer than dietary supplements because they seem more approved of by the FDA. Manufacturers need to be able to support their claims. Put the burden of proof back on the manufacturer without it being a crushing weight of red-tape to do so. Companies who are manufacturing pure dietary supplements will be able to support their claims. Others will have to face that they are manufacturing inferior products that do not meet standards.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Manufacturers, Marketers and Distributors need to be able to speak TRUTH without fear of being gagged. The FDA needs to remember why it exists -- which I understand to be that the FDA makes sure that food, drugs, and dietary supplements are safe for consumption, and if there are warnings, that these be made known.

EC -167