Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -209

Accepted - Volume 4

Comment Record
Commentor Ms. Janet Gilles Date/Time 2002-07-26 09:45:15
Organization Texas Realty
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? Food products are inherently safer than drugs which must prove toxicity to be approved for the public. The government cannot guarantee safety of everything, but only the standards which it measures. At present, there is no guarantee that the products even contain what is claimed. It is to our advantage that knowledge be advanced by the public. An all knowing government will come to resemble the inquisition.
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? AS time passes, some biologics will prove to be widely helpful thoughout the population. It is valid for claims to be made on the bottle. The government cannot know everything that is true and should not attempt to restrict claims about new discoveries, except to require that ingredients listed on the label be present.
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? Nutrients proven to cure disease cannot make that claim. Here is the nub of the matter. Only toxic substances can claim to be cures, per FDA. THis is a serious failing of the agency. Even if a nutrient tries to go through the process, they are stopped, because there is no toxic level. Proof of toxicity is necessary to legally use the word cure. So free speech is dangerously restricted. We know that 25% of patients who use a new class of nutrient have all symptoms of MS go away. They are able to get out of their wheel chairs and dance. But because the nutrients have no toxicity they cannot be labeled a drug, and now the FDA is considering a restriction to not allow even a claim to improve or help the condition. THis will eliminate all advances in health outside of toxic or other invasive remedies. Possibly a very foolish choice. Science historically advances in directions outside the purview of the established experts.
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? Disclaimers are misleading in themselves. The government should require that products listed on the label be present, but it does not. A disclaimer makes it appear that some regulation is occurring which is not true for herbs and supplements.
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? Known toxicity should be disclosed. Nutritional supplements historically are not widely accepted until thirty years after the original research has been done. See folic acid, now recommended by physicians to prevent birth defects.
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? I would like to see labels reflect the true ingredients listed on them. This would be a valid effort by government. Warnings that the ingredients have not been approved by the government are misleading in themselves.
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? How would this affect Ritalin? WAs it ever studied for long term use by children? Is it now?
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? History shows that scientific knowledge changes over time. To forbid claims that the government is still unaware are true does not help the progress of science. The government is not our parents and we have to make our own choices.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I would like to see the government require that ingredients listed on the label actually be present in the bottle.

EC -209