Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -438

Accepted - Volume 6

Comment Record
Commentor Dr. Dion Dennis Date/Time 2002-09-18 18:00:10
Organization Dr. Dion Dennis
Category Academic

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? The FDA's should take into active consideration the fact that its domain is a mass domain, public health and welfare. On balance, this concern should take precedent over any assertion, grounded in individual rights argument, that equates corporatist commercial speech/free speech on an equal footing. This agency would be most effectively fulfilling its mandate by restricting corporatist/commercial speech, which is aimed not at the public good, but at the maximization of private profit. Such commercial speech uses a vocabulary of motive (education) as a means to their desired end -- increased profitability. The right to maximize profit at public expense does not deserve constitutional protection and -- even when not technically untruthful, euphemistic or misleading -- may by omission, emphasis or emotional appeal spur consumer purchasing patterns that are contrary to public health goals. The courts rationalize commercial speech protections on the grounds that commercial speech provides information to the public. If this is the goal -- rather than protecting an inherent right to advertise -- it makes sense for the government to make determinations about whether the commercial information actually will educate the public to advance public policy goals. In many instances, this will not be the case. And regulatory agencies are in better position to make such determinations than the courts, since the courts have systematically and unwisely granted the rights of personhood to bureaucratic and corporatist entities while allow them to externalize their responsibilities onto the public commons. Given that we have to live with the reality of commercial speech protections, it should be enough for the FDA or other federal agencies to show that regulations reasonably work to directly advance legitimate governmental goals. The goals of public health must be actively weighted against the aggressive advertising practices of pharmaceutical oligopolies. Therefore,the FDA and other agencies should not be subject to a least restrictive test, where they are forced to show that there was no less speech restrictive means to achieve their goal. One can always imagine less speech restrictive means -- even if they are politically unachievable or would fail to work in practice. The weight of the test should not be slanted to favor (as they are in the least restrictive alternative test) the rich and powerful, over public health interests. Broad commercial speech protections will inappropriately transform legislative or regulatory decisions about public health issues into constitutional issues. (This is an argument Justice Breyer made in dissent in Western States Medical Center.) Because corporations should not have any constitutional protections, and because commercial speech should not receive constitutional protection, the FDA should press as hard as possible against existing limitations in these areas. It's time for the FDA to work toward testing the body of law that began with the Santa Clara case that granted corporations personhood in the last quarter of the 19th Century.
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? While consumers should be empowered with information about pharmaceuticals, DTC ads are about promotion, NOT education. True education requires those who weigh the full body of information, not selective disclosure for purpose of profit or public relations. Often, DTC ads understate safety risks, which is likely to lead to inappropriately increased consumer demand. Much of the public mistakenly believes DTC ads receive special clearance from the FDA -- and that only the safest drugs can be advertised on television -- leaving consumers vulnerable to and overly trusting of DTC promotions. DTC ads rountinely fail to provide key information to consumers: independent longitudinal study results that include how the success rate for the drug is defined, the efficacy of alternative treatments, how long the drug must be used, and at what dosage. Evidence shows that physicians are influenced by advertising (and time constraints) to make poor prescription decisions; consumers are similarly affected. DTC ads explicit encourage consumers to demand brand-name products from doctors. Evidence suggests doctors are influenced by these demands for specific drugs, and sometimes prescribe requested medicines despite ambivalence about the choice of treatment. Like the current Clarinex campaign, many DTC ads encourage to consumers to buy needlessly expensive products instead of cheaper generics, burdening the overall health care system. Given the ubitquitious nature of DTC advertising, the widespread abuses, and the paucity of evidence suggesting DTC ads contain significant educational information or improve patient well-being, the FDA should be moving the in direction of more rather than less regulation of DTC ads, in the context of intelligently managing a burgeoning health care delivery system. * The FDA should issue regulations specifically for DTC advertising, to establish clear rules for what is and is not permitted. * One important step would be pre-review by the FDA of ads; the current system relies on self-restraint by drug manufacturers and a very inadequate and underfunded system of FDA warning letters sent after offending advertisements are aired or published. * DTC advertisers should be required to run corrective ads after receiving FDA warning letters Consumers should be empowered with useful information. This should be provided by FDA on the Internet, in inserts included with pharmaceuticals, and elsewhere. The information should be written in easy-to-understand language, and include information on success rates, and comparative efficacy and pricing data. This is how consumers' right to know should be satisfied, not through promotional advertisements that are inevitably slanted toward profitability beyond all other considerations.

EC -438