Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -295

Accepted - Volume 4

Comment Record
Commentor Ms. Patricia Onsager Date/Time 2002-07-30 23:17:24
Organization Ms. Patricia Onsager
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? Yes, by definition, drugs are toxic substances that alter natural bodily functions. Dietary supplements, on the hand, are food substances that simply supply nutrients the body needs to function properly. Therefore, regulating speech about drugs more strictly than speech about dietary supplements is reasonable when you factor in that drugs are likely to have more serious side effects and treat symptoms rather than the underlying cause. The problem with marketing drugs directly to consumers is that it takes a professional to properly evaluate the need for the substance, and to properly explain the risks, namely contraindications and side effects.
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? The drug industry's promotion of prescription drugs leads to over-prescriptions. Such advertising fosters the often mistaken belief that drugs cure the disease when, in reality, most drugs attack the symptoms and not the underlying cause. The current approach therefore leads to inadquate understanding by the patient of the steps that need to be taken to actually address the underlying cause of disease. Doctors, who are rarely adequately trained in nutrition, very often unable to advise the consumer on how to restore or maintain the natural health biochemistry of the human cell and body.
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? For a claim to be made that a nutrient, whether it is a conventional food or a dietary supplement, has a particular beneficial effect, it must be supported by some credible scientific research. For example, research has shown that tomatoes supply a substance that other reseach shows maybe helpful in preventing cancer. That research is sufficient to support the claim that tomatoes supply this particular nutrient even though there is double blind study testing the rate of cancer in tomatoe eaters verses non-tomatoe eaters. The DSHEA, the Dietary Supplement Health & Education Act, does a very adequate job in setting the appropriate standard for 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? We would like to see three categories of regulated product: drugs, food labels, dietary supplements, and a new classification called Nutraceuticals. Nutraceutical can be defined as any non-toxic food component that has scientifically proven health benefits, including disease treatment or prevention. Consumers should be empowered to access Nutraceutical scientific data.
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? If the substance is a drug, then a claim for off-label use should meet the same requirements for an on-label use, because the same information is essential for consumer understanding of a toxic substance.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Once there is credible scientific evidence that over-consumption of certain food substances may be harmful, the FDA must consider how to better educate the consumer and to avoid the targeting of particularly susceptable segments of the population. For example, soft drink and sugared cereals manufacturers target children when the scientific evidence demonstrates that these substances lead to obesity, diabetes, and other nutritionally based maladies.

EC -295