Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -272

Accepted - Volume 4

Comment Record
Commentor Ms. Peggy Kralik Date/Time 2002-07-29 17:37:37
Organization Ms. Peggy Kralik
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? I believe that drugs need to be held to a higher standard than dietary supplements - drugs kill people, dietary supplements do not (with rare exception). Also, a legal definition of cure needs to be implimented by the industry and FDA. And natural. Doctors are people, too, and although they understand drug use better than non-medical general public, they are suseptible to hype. It should be clearly conveyed to the doctor what the negative side effects are of the drug - and the number of deaths and/or serious complications in the drug trials.
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? Drugs should not be advertised on television and in print and other media, and should not be allowed in JAMA and other magazines intended to educate medical personnel. It is a conflict of interest in JAMA and other periodicals. The easily-influenced general public will ask their doctor about a drug they saw on tv even if they don't know what it's for. I actually saw an ad on tv that just said to ask their doctor if the drug was right for them without even mentioning what it was perscribed for. This puts pressure on the doctor to try it out on the patient, fearing the patient will go down the street to the next doctor who will prescribe it. Drug advertisements are taking the decision of what is best for the patient out of the doctors' hands. These advertisements also increase the price of the drug being advertised to cover the additional cost. It's also time that the wining and dining of doctors was stopped! The drug companies are buying the doctors. It has been stopped in other industries - no palm greasing - no large gifts - no financial or other incentive (take con ed in Hawaii - free of charge). Con ed for complimentary and/or integrative treatments should become mandatory - so many hours (say 3) per con ed time period. Many doctors know less about what's out there than their patients do, and that's dangerous, if for no other reason than drug interaction. Many patients won't tell their doctors what they are taking because the doctor belittles the patient or demands the patient stop taking the supplement.
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 believe that supplements and fortified foods are looked at differently by the general public because of the form (food versus pills, generally). Again, the definition of natural is so important, because, not only do I believe that the vitamin, mineral, herb, nutraceutical, etc. should be disclosed on the label, but I also believe it should be noted whether it is a manufactured sythetic, isloted from a natural source, or is a whole-food complex. Most people do not know there is a difference in vitamin C, for instance, or vitamin E, etc. - and that it can affect the body differently. If the added ingredient is stated such as: Fortified with vitamin E in a natural, mixed tocopheral Visit our website at ..... for information, or write to..... - or, call 800-..... At least this would give people the opportunity to do research on something if they want to.
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 small print is rarely read by people - they mentally think - oh, that's just the mandatory disclaimer. The small print is also generally harder to read than the balance of the label. I believe the disclaimer should be the same size and start out as Disclaimer...
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 believe that people read Warning disclaimers, especially if they are larger type, and/or in the color red - I know I certainly do, and know a lot of people that do.
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? In my opinion, there should be no difference in the claim being made no matter the medium. Labels are advertisements, too.
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? Why doesn't FDA approve off-label uses if they are proven to be effective (and don't kill the patient)? In lieu of that, off-label uses should not be advertised. Again, it should be up to the professional - the doctor - to recommend which drugs for which use. There is no way that the FDA can be everywhere all the time, and thus no way that FDA can effectively regulate speech. They can regulate print and recordings, etc., however.
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 should not attempt to regulate free speech.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? We will always have the right to free speech. When that free speech comes from a person holding themself up to be an authority, such as a doctor, to a patient, there is the burden of responsibility. I believe we already have that one covered - that's what malpractice insurance is for.




EC -272