Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -287

Accepted - Volume 4

Comment Record
Commentor Dr. Tim Jaeger Date/Time 2002-07-30 12:53:39
Organization Dr. Tim Jaeger
Category Health Professional

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, speech about drugs should be regulated more comprehensively because of the relative risk differentiation between drugs and dietary supplements. In 1998, it was noted in the JAMA that correctly prescribed pharmaceuticals are the fourth leading cause of death. Dietary supplements are basically non-toxic, and rarely are implicated in the death of a user.
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? Current regulatory approach and its implementation by industry definitely leads to an over-prescription of drugs. Disease is not a sign of a deficiency of drugs, but rather a sign of systemic dysfunction that needs to be looked at from the perspective of the whole, not its parts. As long as it is advocated that the answers to what we call health are to be found in the form of a prescription drug, there will be an over-reliance on drugs. In the Dorland’s Medical Dictionary, health is defined as a state of optimal physical, mental, and social well-being; not merely the absence of disease and infirmity. I believe healthcare should be called sickness care. It should also be noted that North America has the best sickness care in the world, but not the best healthcare. According to the WHO in the World Health Report 2000, America ranked 24th. Healthcare costs for the US in 1999 were over $1.2 trillion, the most of any nation and the highest in terms of expenditure per person--$5000 per person. By 2011, that will increase to $2.8 trillion. (Health Care Financing Administration – March 2002) Paracelsus himself knew that all drugs were poisons, however, mainstream medicine has imbibed ‘drugs’ with the magic bullet cure mentality. One cannot expect an answer to the atrocious disease statistics prevalent in industrialized countries, if one looks in all the wrong places. It is my opinion that imposing stringent labelling laws on dietary supplements and removing the DSHEA is a move saturated in moving backwards as opposed to forwards. We must become proactive and envision a future of prosperity and health, not one full of sickness and death. Hippocrates stated, “Let your food be your medicine and your medicine your food.” Dietary supplements are more closely connected to food than any drug ever will be, and that is acknowledging the fact that many drugs come from many herbs found in nature.
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? I believe that disclaimers should be smaller to underscore the relative risk issue that I spoke about earlier.
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? No, the First Amendment does not and should not afford the Government greater latitude over labels.
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 speech related regulations do not advance the public health concerns they are designed to address. Rather, they are interpreted as warnings without competent knowledge about relative risk.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The DSHEA act should be allowed to continue as is.

EC -287