Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -395

Accepted - Volume 6

Comment Record
Commentor Mr. Josh Smith Date/Time 2002-09-11 07:34:40
Organization Mr. Josh Smith
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? I believe that the FDA should be given the power to decide whether certain speeches are misleading, and/or incorrect, and that the companies should be able to provide documented proof of anything that they claim.
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 way the current advertising is set up, patients only hear usually about one particular drug for thier ailment, and even then may not know many of the bad sideaffects of such a drug may have. The FDA's approach in enforcing commercial advertising laws more strictly would allow patients to know thier choices, and realize that they have a choice mainly, as it is most drug commercials are marketted directly to them as a person.
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? I'm not so familiar on how the FDA works for dietary things, but in my opinion they should keep the current approach, and if a querie is made about a certain food or dietary supplement, then step in and require all the documented evidence of thier claims, and the fda should then give thier own thorough testing of the products to make sure it lives up to it's statements.
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? All claims should be made the same size, or a very similar size, whether good or bad, consumers should be able to spot everything about the said product without having to look for it, otherwise most of them simply won't.
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? Depending on the warning itself, most warnings could be considerably effective if they were in a readable size font on whatever is advertising the product, they should be the same size as the benefits, otherwise they would most likely be overlooked by the modern day consumer.
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? The first admendment should apply more limitedly to corporations because corporations have more power, they should be checked for false advertising, or inaccurate information and even fined if need be. Freedom of speech is a must, for a singular human being, but for a company to mislead an individual on basis of freedom of speech it is a laugh in the face of our founding fathers.
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? Permitting speech of the off-label uses would limit the FDA's power over being able to commercial advertisement. Anyn off-label uses claimed should also be investigated by the FDA, and if found to be untrue, some penalty should be put upon the marketter.
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? FDA's speech-related regulations are a must in a current society of consumerism, these current ads read off like candy ads. If there were more restrictions lifted on the speech it would just get worse and worse, and probably drift back to the old fountain drink days where everything was a tonic that could cure all ailments and nobody was there to say otherwise.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? No, the first amendment applies to the individual, corporations should not be treated as individuals, because they are not individuals they are a group of greedy people with a lot of power, and as such should have to follow a different set of laws made specifically for them, and not specifically for the individual.

EC -395