Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -114

Accepted - Volume 2

Comment Record
Commentor Mr. Mark Bowker Date/Time 2002-06-05 09:39:38
Organization Trigon Blue Cross Blue Shield
Category Health Professional

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? This is not about free speach, this is about lies and misinformation from Pharma. The FDA needs to regulate and confirm that the free speach being provided by Pharma to thousands of doctors and millions of americans is accurate and will err on the side of safety.
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? Pharma should be allowed to market their products to consumers like any other manufacturer markets their products to potential clients. I have no doubt that this has increase the use of presription drugs in the appropriate individuals, however, it has also increase the use of expensive brand name drugs in place of more economical equivalent generic alternatives (NSAIDs vs. CoxIIs). Once again, the marketing must be accurate and err on the side of safety. Once the patient reaches the doctor's office, we hope, at this point, the most appropriate drug will be selected for the patient by the physician.
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 it's going to make a health claim, whatever the product might be, there must be scientific data to support the claim and approved by the FDA.
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? Pateints must know the risks. I'm for them signing a statment that confirms their understanding of risks associated with a new prescription. The warnings and risks should be given priority. That being done, the pateint can participate, as better informed consumer, in the selection of a drug product along with the physician.
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? This is not going to be easy but need to be done none the less.
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? No comment
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? Once again, there must be scientific, peer reviewed data, and FDA approval over any claim of effectiveness. Any off label comments or claims will be taken, by many, as being gospal. This will taken advantage of by those marketing products looking to increase profits.
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? The restrictions are necessary to protect the health and safety of the American public.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? No

EC -114