Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -193

Accepted - Volume 4

Comment Record
Commentor Mrs. Brenda Lowery Date/Time 2002-07-25 20:02:44
Organization MannaHealth Consultants International
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 don't understand the wordy question in 1 above. But I do want to voice my opinion that DSHEA should not be stopped.True there are some nutritional companies that have no credibility to their products but that is not true for all companies. Hundreds of thousands of people have been helped more because of certain nutritional supplments that have ever been helped by the use of drug therapies.
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? Everyone when totally honest will admit that drug companies are never concerned about whether that drug really does what it claims to do. Because they will just make another drug to fix the problems with that drug and people trust their medical professionals and will be abused by the drug companies' efforts to just make a sale. Nutritional companies work on prevention of illness. The proof of whether these supplements work is time and they are working. Drug companies are very fearful of losing a very large portion of sales because people want to be well not just to be treated ongoing until death.
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? If the science and I mean real proven science does show that something is helped by that supplement then the public has the right to know about it. False undocumented claims should not be allowed and that is certainly what should also follow with drugs but they do not follow that rule.
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 truth should be stated.
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? Companies of any kind drug or nutritional should never be permitted to false information. Certainly if a product is toxic that should be noted boldly so that the consumer is aware of the potential danger.
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? Drug companies have lots of money to spend of advertising and look what they tell the public. They pay people to play act that they are the ones getting results from a product. Paid sponsors should not be allowed ever. If someone has to be paid to say something that puts doubt in my mind as to whether that comment is true. People falsely believe that because an insurance companies pays for the prescription that that gives it companies should be looking at paying for science backed nutritional supplements. It is cheaper to keep someone healthy than it is to pay for someone who is sick.
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? If the comments are true there is nothing to be concerned about. They must be proven true with science not just testionials of paid product users.
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 understand the questions.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The statements must be proven true.

EC -193