Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -278

Accepted - Volume 4

Comment Record
Commentor Ms. evvie moravec Date/Time 2002-07-30 00:29:58
Organization Mannatech
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? Dietary supplements should not be regulated in any way. We as consumers should have the freedom to make choices about our health. Not everything needs to be standardized. Preserve the DSHEA Act of 1994. I have personally been freed of anti asthmatic drugs and symptoms, menopause symptoms and my energy and moods have improved tremendously. I do not want to lose my ability to be healthy through someone's need to control the world. Preserve the DSHEA ACt.
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? Tke a look at the statistics. When drug companies spend more on advertising than on research, something is wrong. Not only does the adverising lead people down a path that is inherently unhealthy, the drug companies are also in the pockets of the medical profession. Dietary supplements should not be regulated in any way. We as consumers should have the freedom to make choices about our health. Not everything needs to be standardized. Preserve the DSHEA Act of 1994. I have personally been freed of anti asthmatic drugs and symptoms, menopause symptoms and my energy and moods have improved tremendously. I do not want to lose my ability to be healthy through someone's need to control the world. Preserve the DSHEA ACt.
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? Dietary supplements should not be regulated in any way. We as consumers should have the freedom to make choices about our health. Not everything needs to be standardized. Preserve the DSHEA Act of 1994. I have personally been freed of anti asthmatic drugs and symptoms, menopause symptoms and my energy and moods have improved tremendously. I do not want to lose my ability to be healthy through someone's need to control the world. Preserve the DSHEA ACt.
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? This conversation is a waste of my and other taxpayers money. Dietary supplements should not be regulated in any way. We as consumers should have the freedom to make choices about our health. Not everything needs to be standardized. Preserve the DSHEA Act of 1994. I have personally been freed of anti asthmatic drugs and symptoms, menopause symptoms and my energy and moods have improved tremendously. I do not want to lose my ability to be healthy through someone's need to control the world. Preserve the DSHEA ACt.
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? Most consumers of supplements do research on what they are taking. I read and then choose and do not really heed warnings. Dietary supplements should not be regulated in any way. We as consumers should have the freedom to make choices about our health. Not everything needs to be standardized. Preserve the DSHEA Act of 1994. I have personally been freed of anti asthmatic drugs and symptoms, menopause symptoms and my energy and moods have improved tremendously. I do not want to lose my ability to be healthy through someone's need to control the world. Preserve the DSHEA ACt.
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? Dietary supplements should not be regulated in any way. We as consumers should have the freedom to make choices about our health. Not everything needs to be standardized. Preserve the DSHEA Act of 1994. I have personally been freed of anti asthmatic drugs and symptoms, menopause symptoms and my energy and moods have improved tremendously. I do not want to lose my ability to be healthy through someone's need to control the world. Preserve the DSHEA ACt.
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? Way too much control here. Dietary supplements should not be regulated in any way. We as consumers should have the freedom to make choices about our health. Not everything needs to be standardized. Preserve the DSHEA Act of 1994. I have personally been freed of anti asthmatic drugs and symptoms, menopause symptoms and my energy and moods have improved tremendously. I do not want to lose my ability to be healthy through someone's need to control the world. Preserve the DSHEA ACt.
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? Dietary supplements should not be regulated in any way. We as consumers should have the freedom to make choices about our health. Not everything needs to be standardized. Preserve the DSHEA Act of 1994. I have personally been freed of anti asthmatic drugs and symptoms, menopause symptoms and my energy and moods have improved tremendously. I do not want to lose my ability to be healthy through someone's need to control the world. Preserve the DSHEA ACt.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Dietary supplements should not be regulated in any way. We as consumers should have the freedom to make choices about our health. Not everything needs to be standardized. Preserve the DSHEA Act of 1994. I have personally been freed of anti asthmatic drugs and symptoms, menopause symptoms and my energy and moods have improved tremendously. I do not want to lose my ability to be healthy through someone's need to control the world. Preserve the DSHEA ACt.




EC -278