Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -219

Accepted - Volume 4

Comment Record
Commentor Dr. David Wilkins Date/Time 2002-07-26 13:01:02
Organization Dr. David Wilkins
Category Health Professional

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? Pharmaceuticals need rigid oversight. There are issues of toxicity, safey, LD 50, and the difference between Lethal, toxic and therapeutic doses. Not so with nutraceuticals. Supplements known to have health benefits with little or no side effects should not require the rigor of a toxic drug. The DSHEA act of 1994 provides the language needed for natural product oversight, and the responsibility for proof of toxicity for a natural product should lie with the FDA. Nearly all the countries in the world who provide for wide use of natural products show up much higher on meeting accepted health goals that the US. See JAMA July 2000. It is the drug companies in large measure for economic reasons that are largely responsible for our poor showing. They need to get out of the public's way to good health. They are interested is profit not the health of the public. They need tighter oversight, and the food supplement industry needs to be provided more latitude to serve the public need.
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 appproach of the FDA should stop the marketing medications directly to the public on TV and Radio. In addition all drug testing funded by drug companies should be stopped. The facts are that when clinical trials are funded by drug companies 90% of the time they are found to be effective and safe, but when the same medication are tested by independent researchers only 50% show the same result. The message is clear. The FDA should regulate how clinical trials are conducted taking the drug companies out of the picture.
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? The is clear evidence that good nutrition translates into good health. There is no good evidence that drugs lead to good health without significant risk. Labeling of dietary supplements should be regulated to be sure the product contains what it claims to contain. The food supplement industry should have greater freedom to address the specific health benefits addressed by their products.
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? Discalimers should be the same as claims
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 warnings should not create unnecessary caution or fear of using the product, and the claims should should not be exaggerated. The public, contrary to pubic opinion is not stupid and easily dupped. They need to be a partner in their health care, and not dictated to by drug company or Dr.
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? At the present it seems to me that the FDA has a reasonable balance and is within its authority to act. I think that the focus of regulation needs to be on the public interest and not the economic interest of the drug companies who always complain for econmic reasons. This country is way behind most others in meeting health goals and the FDA should study why and seek authority to change these facts. Current regulation and practice methods are failing us. The other nations spend far less to get it done and rank much higher in meeting their health goals (See the World health report 2000, World Health Organization.)
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? I don't think current regulation needs to be changed in this regard.
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? In the case of drugs yes? In the case of quality food supplements, no.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? There should be more openess to letting food and natural supplement companies address the health benefits of their products when there is clear truthful, nonmisleading evidence to support the claim.




EC -219