Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -202

Accepted - Volume 4

Comment Record
Commentor Mr. Jim Turner Date/Time 2002-07-26 00:06:57
Organization Advanced Wellness Technology
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 implies the freedom to speak the truth about any subject without obtaining special permission or license to speak. If claims are based on documented evidece and research without intent to deceive or mislead factual information should be unlimited and uncontrolled.
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? If documented adverse effects of a product are valid enough to be included on the label and product literature, they are valid enough to receive equal time and space in product advertisements of any kind. Deception involves either false claims benefits or ommited warnings of harmful effects.
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? To limit what may be said about any safe nutritional or nurtaceutical product before the facts have been established by documented research is both restrictive and ineffective. Control need to be limited to misleading and false claims where fraud or incompetance exists. When prosecution of those who reveal the truth is pursued and licensed the Truth, the whole Truth, and nothing but the Trugh no longer exists.
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? If warnings and disclimers are valid and based on validated science they must be included on the packaging. If they are but vague claims or unproven acqusations they should be omited until documentation has been established.
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 should serve to accurately describe all possible harmful effects of product in clear factual terms. The purpose should be to accurately warn of actual harmful effects.
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? Actual harm of any product is limited to actual absence of known harmful effects or exageration or unproven claims as to proposed benefits. Factual and complete disclosure of any documented information is in no need of regulation.
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? Fraud whether mistaken or intentional should be subject to regulation and prosecution. The free interchange of factual and accurate information about the benefits of any product is free speech.
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 duty of the FDA should be limited to the advancement of health concerns and the elimination of fraud and false or dangerous remedies. When the FDA is used or controled by any one interest both the intent and effectiveness of the FDA invalidated. People's interest is the only proper reason for the existence of the FDA.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The lie advanced by the Pharmaceutical Drug Monopoly that pharmaceutical toxic drugs are the only available remedy for the existing health crisis in America must be stopped. Many safe and effective remedies have been proven to support the body's ability to heal and repair itself even in the case of diseases for which conventional medical offers absolutely no hope. Citizens must be give access to existing information that alternatives with safe proven benefits exists without fear of prosecution for simply tellng the truth.

EC -202