| Comment Record|
Mr. Brian Berger ||
2002-09-11 11:38:43 |
Mr. Brian Berger |
| 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 position should be that public health takes priority over commercial speech considerations, and the agency should do everything it can to defend its authority to restrict commercial speech in the effort to protect public health.
* The FDA should emphasize that commercial speech serves promotional purposes much more than educational ones. These promotional purposes do not deserve constitutional protection and -- even when not technically untruthful 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.
* If there are going to be 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 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.
* Overly 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.
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 it is vital that consumers be empowered with information about pharmaceuticals, DTC ads are about promotion, not education.
* Many 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 generally fail to provide key information to consumers: success rate for the drug, alternative treatments, how long the drug must be used.
* Evidence shows that physicians are influenced by advertising to make poor prescription decisions; consumers are similarly affected.
* DTC ads encourage consumers to demand brand-name products from doctors. Evidence suggests doctors are influenced by these demands, and sometimes prescribe requested medicines despite ambivalence about the choice of treatment.
* DTC ads encourage to consumers to buy needlessly expensive products instead of cheaper generics, burdening the overall health care system.
* Given the proliferation 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.
* 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.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority?
* While the FDA does not currently have jurisdiction over tobacco, there are numerous initiatives to give the agency such jurisdiction -- including some legislative proposals favored by the tobacco industry -- and good reason to expect Congress will confer jurisdiction in the near future. FDA should consider the issue of tobacco advertising in determining its posture on commercial speech issues.
* There is an abundance of evidence that tobacco advertising has extremely harmful consequences, leading to increased smoking rates, especially among youth.
* Studies have found that:
- advertising campaigns using universal themes -- not just those obviously directed at youth -- are effective at luring youth into smoking;
- the same advertising that encourages or discourages brand switching is also effective at convincing new smokers to start;
- even very young children have enormous recall of cigarette brands and advertising, thanks to industry marketing efforts;
- internal industry documents show Big Tobacco acutely aware of the importance of advertising and marketing in seducing new smokers.
* Appropriate public health policy would involve a complete prohibition on tobacco advertising and marketing. Lesser measures might include various bans on restrictions on particular types of advertising most likely to reach kids. There are significant public health benefits to be obtained from restrictions on advertising that could probably not be justified on the grounds that they are untruthful or misleading.
* Moreover, there is a wide array of desirable tobacco control measures (such as cigarette tax increases). If every advertising restriction must show it is the least-speech-restrictive means to lessen smoking, a court could argue that one or another of these alternatives should be used in place of restrictions on advertising. It is thus crucial that FDA work to advance a constitutional jurisprudence that is less protective of marketing.
* There is wide international support for advertising bans -- or at least severe advertising restrictions -- based on overwhelming evidence of the public health benefits from outlawing tobacco advertising.