Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -11

Accepted - Volume 1

Comment Record
Commentor Mr. Thomas Kniest Date/Time 2002-05-28 19:10:26
Organization Mr. Thomas Kniest
Category Individual

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? a - Yes, since the FDA is in the position of actually deciding whether or not a drug can go to market, they can limit what the manufacturer can claim for the product, based on the available test data. b - answered above c - The FDA should not interfere with marketing EXCEPT to review and disallow inherently untrue statements. d - No; there is a lot of consumer protection already available in the US through the media. The basis for founding our country was common sense. Consumers have protect themselves, ultimately. To subjugate my personal opinion to learned intermediaries is an insult to me, and probably anyone else who is an adult and can read.
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'm a lay person, and can't comment on relevant legal authority. This is a huge, multipart question. My opinion is this: Current drug company practice of advertising drugs, with all the multipage fine print, ending with a suggestion to ask your doctor if this drug would be beneficial to you, is beyond the consumer to understand. What would be more useful to the consumer would be generalized ads that (for example) Smith-Kline produces products that physicians have found useful in the treatments of the following medical problems - and then tell the consumer to consult his physician. Of course, the more detailed ads are suitable for publications directly applicable to medical personnel. I don't think consumers, in general, have any idea of the potential problems of taking prescription drugs. They just trust their physicians. I think our culture expects some type of fix when visiting a physician, and many physicians cooperate with this mindset, rather than saying that the patient will eventually get better on his own. The detailed ads now in vogue do nothing to protect the patient. I don't know anyone who reads the details (except for me) of the medications they take. I think the current environment makes it difficult for a physician to suggest treatment involving supplements rather than prescription drugs. The FDA may share some of the fault here with the medical societies. Physicians need more freedom here to apply their knowledge.
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 think all true statements are protected speech. Rather than having a statement that the FDA does or does not concur with some claim, the seller should be able to make a true statement, and, perhaps, quote ONE recent scientific journal article where statistics support the claim. In today's internet world, accessing that article would result in a lot of hits on similar studies. Thus, the consumer would be educating himself, if he cares to, which is the best of all worlds, in my opinion. There is so much boiler plate in advertising today that is required by the government or suggested by company attorneys that virtually all people ignore it. Thus, its very purpose is thwarted by its preponderance.
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? We don't need disclaimers for true statements. A disclaimer should not bestow any protection for a false statement.
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 public would be well served by being warned about known levels of overdose for supplements. My suggestion for consumer disclosure would be the availablity of a single flyer produced by a supplement company which includes all of its products, along with references to scientific articles, suggested minimum and maximum dosages, and a brief description of what health benefit is supported by the available data.
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 actual product container should contain the most information. In the absence of my flyer idea, above, the media advertising should urge the consumer to read the label(s) before purchase and use.
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? A supplement can have different uses and different results, based on dosage. The FDA cannot anticipate every situation. Unless they can show inherent harm in a normal dosage, the use should be protected. Once again, all true statements, whether by the manufacturere, distributor, or marketer, should be protected speech.
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? Current FDA speech related regs do NOT advance public health. The FDA should never get in the way of true statements made in promoting a product.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Once again, I am a lay person. I think my other answers address this to my maximum potential.




EC -11