Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -306

Accepted - Volume 4

Comment Record
Commentor Mr. Paul Manning Date/Time 2002-09-04 19:50:09
Organization Mr. Paul Manning
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? Interesting example, as speech concerning dietary supplements is almost as inadequate as drugs.
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? I believe the advertisements have gotten too far ahead of the FDA's ability to monitor them. Prescribable drugs should not be advertised. This guise of information sharing is ridiculous. I am of the belief that such advertisement causes an artificial inflation in the price and the prescription rate of the advertised products. The Fed needs to lead in the protection of the health of the citizenry. Any policy that has the industry leading will lead to abuses in the interest of bettering profits. Allowing advertisements, and the boom of pharmacutical stocks in the last few years (relative to the rest of the market) can not be written off as coincidence.
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? Radiated food, truly organic food and imported food should all be clearly marked and defined. The definition of organically grown food has recently been described in such a liberal fashion that the large coprorate food generators that make no alterations to current practices can consider their products organic. That is preposterous. So far as suppliments are concerned, those herbal suppliments should be labelled, defining what part of the plant was used so real potency can be considered. Use of the leaf, when the medicinal value is derived from the root is of no value, and labelling should be improved to provide the consumer an opportunity to learn how medicinal their supplimental choice may be.
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? I am of the belief that warning labels have been handled very well by the FDA. It is the responsibility of the consumer to read the product labels prior to purchase and use. Larger labels, or a different font won't make any difference. The black letters on the white label is as clear as you can make it.
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? Advertisements and labels must correlate. If there is no truth in advertisement regarding the food or suppliment advertised, the advertisement needs to be pulled and corrected. The advertisement serves as a type of warning label in terms of food or suppliments. If the ad says something contrary to the label, the label is no longer effective, for the consumer has already had that decision point made for them (via the ad) with erroneous data.
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? When corporations enjoy First Amendment protections it essentially nullifies the speech rights of individuals, since individuals cannot afford the massive advertising campaigns that corporations wage, and so cannot talk back. The FDA needs to extend the consumer protection to include advertisements, and any other food and drug related speech from corporate entities. The First Amendment does not apply to corporations, nor should it.
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 don't know what the FDA is trying to accomplish by granting fewer restrictions on speech made by producers of food or drug products. Such an idea runs counter to the maion purpose of the FDA: protecting the consumer.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Advertisements, proper food labelling regarding locality, organics and radiation.

EC -306