Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -343

Accepted - Volume 4

Comment Record
Commentor Mr. Thomas Hansen Date/Time 2002-09-05 22:56:21
Organization Mr. Thomas Hansen
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 strongly feel that the advertisements for prescription drugs is not in the public interest because it encourages uninformed patients to pressure their doctors to prescribe medications that may not be suitable, while doctors are already under pressure from drug manufacturers to prescribe those same drugs. In addition, allowing such advertisements encourages irresponsible behavior among drug manufacturers. I call such advertising irresponsible because drug manufacturers biggest point they always raise when faced with potential price controls is that the money is needed for research. Yet, they spend millions upon millions of dollars advertising prescription drugs that, assuming they are effective, would be prescribed by doctors anyway, thus also funneling money away from needed research, and putting more upward pressure on the price of drugs. Such upward pressures are very much not in the public interest, hence such advertising is irresponsible.
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 have addressed most of these points in my response #1 above. As far as under-diagnosed diseases go, public service and other types of public education programs would be far more economical, and by their very nature much more in the public interest than advertising for drugs.
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 the FDA should judge claims based on facts. No seller of conventional foods OR supplements should be allowed to make false statements regarding their products.
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? I feel that any arrangement of claims and disclaimers on a package which has the effect to mislead consumers should be considered the same as making 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? Warnings should be a simple and straightforward as possible, with no legalese involved.
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? Lies are lies, whether in an advertisement or on a label.
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? I believe that commercial speech which is untrue or misleading should be treated as fraud, and not be subject to First Amendement protections.
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? See my answer to #9 below for some perspective on this.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I believe that the FDA must act at all times in the greater public interest, and not in the interests of drug companies, politicians, or other special interest groups. The FDA must at all times aggressively pursue all avenues available to it to these ends. If certain actions are deemed in violation of the First Amendement by the Supreme Court, then the FDA must aggressively pursue whatever other avenues are available. For example, if the FDA pulls a drug off the market because the manufacturer was going to make false claims about it in advertisements, does this constitute prior restraint? I would argue no, because the FDA did not act directly against the advertisements; rather it only acted within its regulatory authority over the drug itself.




EC -343