Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -231

Accepted - Volume 4

Comment Record
Commentor Mr. George DeCarlo Date/Time 2002-07-27 14:45:20
Organization Mr. George DeCarlo
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? Your question of comparing drugs and dietary supplements is not proper. You should first start with Freedom of Speech as a discussion. This freedom was placed in the U.S. Constitution for good reasons and it is not up to an agency of government to decide if this freedom is appropriate for Americans.
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 ads may encourage some people to consult their medical doctors about a drug. But, it is up to the medical doctor who writes the prescription to evaluate whether or not it is appropriate for the patient. And, as many people do not know, pressure and sales tactics such as pharmaceutical companies sending people to distribute their drugs is a place that needs attention. After this please look into the other unholy ties that bind medical doctors with the franchise of diagnosis with drug companies.
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? Again, Freedom of Speech is being neglected by these well crafted FDA questions.
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? The disclaimer inhibits Freedom of Speech since the consumer is not made aware of who required the label and what pressure that agency of government had from entities such as drug companies and medical doctors that support prohibition of all 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? Please start with full and complete labeling of pharmaceutical drugs in normal type being handed out with every prescription. Also, make sure that all negative reactions as listed even though they may be in the PDR. Remember drugs and not supplements kill thousands in the U.S. every year. Start with the place that harms the most people and fix that problem before exploring supplements with their incredible record of safety.
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? Again, Freedom of Speech is not to be reduced by an agency of government.
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? Let us uphold the U.S. Constitution first and then discuss whether or not an act is appropriate.
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 FDA would do the public less harm by leaving the U.S. Constitution and its amendments alone.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should concern itself with the revolving door its employees have with the companies and products it regulates.

EC -231