Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -210

Accepted - Volume 4

Comment Record
Commentor Ms. Denise McDermott Date/Time 2002-07-26 10:08:44
Organization Ms. Denise McDermott
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? Yes, regulating speech about drugs should be more comprehensive than dietary supplements since the chemicals in drugs are more likely to do harm than supplements; current focus on side effects on drugs is adequate and is educating people about the danger
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 don't believe there is enough research done on prescription drugs before they are marketed to the public; every other commercial on TV is for a drug and people are on at least 2-3 drugs at a time with problematic side effects; too many drugs are recalled after deaths - why?
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? I believe that consumers approach conventional foods and dietary supplements in the same category since most supplements are vitamins and/or herbs that are contained in food
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? How about listing the VALID scientific research behind the claims in the same size type - then there's no need for a disclaimer.
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 only harm in eating food and/or supplments is if the consumer is taking prescription drugs and mixing them with certain herbs. A warning about checking with a qualified person about possible drug interactions would be appropriate.
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 should be consistent in advertisements and on labels.
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? Don't people have freedom of speech guaranteed by the first amendment. Perhaps the FDA should explore educating consumers about studies that prove or disprove food or supplement benefits or harms.
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 FDA is losing credibility over their aversion to supplements. It appears the FDA only supports the pharmaceutical companies. Encouraging consumers to become educated about all aspects of drugs, food, and supplementation in regard to personal health would help your agency appear to be open-minded. Many people enjoy improved health because of good nutrition, exercise and supplementation with vitamins, minerals, and herbs.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Stop apparent 100% supporting of the pharmaceutical companies - OKing drugs that later get recalled after harming people - and stop trying to keep people from enjoying good health with proper nutrition and supplementation - and without drugs. Leave DSHEA alone!




EC -210