Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -131

Accepted - Volume 2

Comment Record
Commentor Mr. Gayle Liliedahl Date/Time 2002-06-17 23:46:45
Organization Mr. Gayle Liliedahl
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 is not the mission of our government to protect those who wish to commit dangerous or risky actions, which include taking synthetic drugs prescribed by doctors who are in cahoots with our major multi-billion dollar drug companies, any more than it is to monitor and control dietary supplements. This issue compares to those states who have motorcycle helmet laws and those who don't. If an individual wants to risk their neck riding a cycle without a helmet, then I say let them do so. However, they should realize that insurance, hospitals, and other health agencies might not treat them if they flagrantly violate what is known to be common sense. Recent ads for prescription drugs have shown time and again that drug companies (along with doctor's assistance) have led, and are leading, a huge campaign of deception, with the intent of enhancing profits, not improving our nation's health. The term learned intermediaries is not adequately defined here to elaborate, other than to say that one of these learned intermediaries must be unbiased and free of any preconceived notions for their input to be worthy of note.
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 FDA appears to be politically correct more often than not, regardless of whether the drugs being touted have truly provided cure or simply been a temporary relief from symptoms. The current position does indeed lend to over-prescription of drugs, and over-medication of patients. There are countless thousands of people taking 6 or more high potency synthetic drugs for numerous ailments, and in many cases their quality of life is less than if they took their chances w/o the medicine. Many senior people do in fact trust their doctor to make decisions for them regarding their health, rather than take an active part in determining options. Sadly, the majority of our doctors in this country see on average 10 patients per hour and the 5 minutes or so provide little interaction with the patient in truly attempting to cure them, rather than just treat the symptoms. The FDA approach does in fact limit the ability of doctors to treat patients with alternative methods since any such concepts place an M.D. in danger of being ostracized by his peers as well as government agencies such as the FDA.
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 do not believe there is any basis for looking at conventional foods and dietary supplments differently...I analyze everything I ingest and make my own decisions based on research, not on whether a label says something is untested or not double blind tested.
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? None required as the consumer should be allowed to make their own mind most cases, they will, anyway...
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? A glaring example seems the current warnings on tobacco products which has done little to prevent or reduce consumption in this country. We have never been able to legislate morality or anything like it, even since the days of the Boston Tea Party. So, how can we expect that some form of label, marking, or warning will preclude a consumer from using the item?
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? Where has it become the mission of our government, i.e., the FDA, to protect the consumer? I liken this issue to those regarding the reporting of news each evening...most of the major networks report the news with their own viewpoints and learned opinions...few, if any, simply report the news, while allowing the viewers to make up their own minds & draw their own conclusions.
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? I do not believe that the FDA is truly advancing the public health truly do so would require a total overhaul of our medical society, drug company structure, R&D laboratory support, and a host of other entities that money, power, & influence will not allow to happen in the immediate future.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Lean more toward simply providing untainted facts, without learned intermediaries opinions, or clinical studies slanted by major cash influxes from drug companies, or other such biased inputs. Then, the consumer might have a better chance of making the right choices in maintaining their health & well-being.

EC -131