Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -388

Accepted - Volume 6

Comment Record
Commentor Mr. Salvatore Russo Date/Time 2002-09-10 18:35:40
Organization Mr. Salvatore Russo
Category Individual

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 following article expresses my views more eloquently than I: An 1886 Supreme Court decision established that corporations in the United States are entitled to constitutional protections. Since then, the Court has progressively extended Bill of Rights protections, including First Amendment speech rights, and other constitutional guarantees to corporations. In 1978, the Court established a constitutional right to commercial speech -- speech intended to promote and advertise products for sale, as opposed to political or expressive speech. Since 1978, the courts have steadily expanded commercial speech rights, taking a potentially dramatic step in a decision issued earlier this year. In that decision, Thompson v. Western States Medical Center, the Supreme Court interpreted its commercial speech test, developed in a case called Central Hudson, to make it very difficult for the government to restrict commercial speech. Western States Medical Center involved a provision of a 1997 law that permits pharmacies to make compounded pharmaceuticals -- drugs manufactured on the premises, to serve the specific needs of particular patients. The 1997 law permits compounded drugs to be sold -- even though they have not passed FDA safety and efficacy tests -- but on condition that they not be advertised. The basic idea is to seek a balance: to permit manufacture for specifically prescribed needs, but to prevent pharmacies from circumventing the FDA's safety rules by advertising untested compounded drugs to the broad public. The Supreme Court struck down this provision, holding that it violated the commercial speech rights of the pharmacies. In conducting the Central Hudson test, the Court agreed that there is a substantial governmental interest in protecting public health and preserving the integrity of the FDA drug approval process, and conceded the advertising restrictions might directly advance these ends. But it held that the law failed to satisfy the final prong of the Central Hudson test, whether it is not more extensive than necessary to serve that interest. Justice O'Connor, writing for the majority, posited a series of alternatives to an ad ban, without citing any evidence, or even providing compelling arguments, that these alternatives would work as effectively as an ad ban. But they were enough for the majority to conclude that the advertising restrictions were more extensive than necessary. This holding seems to move the Central Hudson test away from ascertaining whether there is a reasonable fit between the government's commercial speech regulations and its legitimate goals, and towards a much higher level of scrutiny. The Court is beginning to break down the constitutional distinction between political and (nonmisleading) commercial speech -- even though commercial speech protections essentially apply uniquely to corporations, which do most commercial advertising. The Supreme Court justifies this rising level of protection for commercial speech on the grounds that the government cannot legitimately deny the public truthful commercial information to prevent the public from making bad decisions with the information. But why not? If the Court is going to justify commercial speech protections based on the public's right to know, as opposed to the speaker's right to speak, it makes sense for the government to make determinations about whether the commercial information actually will educate the public to advance public policy goals. It is hardly a revelation that advertising contains promotional elements that may drown out its educational benefits. The high level of protection afforded to commercial speech by the courts poses a difficult challenge for regulatory agencies that reasonably seek to restrict advertising, including and especially the FDA, which has good public health reasons to restrict advertising and promotional claims. For example, drug companies now spend billions of dollars a year on Direct-to-Consumer (DTC) prescription drug advertising, with more spent to advertise leading drug brands than Pepsi or Budweiser. These ads encourage consumers to demand, and doctors to prescribe, pharmaceuticals that people don't need. The ads fail to convey the comparative benefits of the marketed drugs to alternatives. They don't reveal price information. DTC ads should be prohibited. But as long as the Supreme Court holds that there are constitutional speech protections, they must be highly regulated. Now, the extent of FDA's authority to regulate DTC ads is somewhat uncertain. Or consider tobacco (not currently under the jurisdiction of the FDA, or any federal health agency). There is an abundance of studies conclusively showing that advertising increases smoking rates, especially among youth. Tobacco ads and promotions should be banned. Commercial speech protections make this impossible. The Court's new formulation may also make even more modest restrictions on tobacco promotion very difficult. There is no question that the Court has made things hard for the FDA, which must maneuver to give itself the greatest possible latitude to restrict advertising to protect public health. Unfortunately, the FDA seems quite happy to forfeit the powers it needs to do its job. In May, the agency put out a request for comments (with a comment period open until mid-September) on issues involving First Amendment protections for commercial speech and the scope of the agency's authority. It appears the agency is looking for excuses to throw up its hands -- Sure, we'd like to do our job, but there's not much we can do. The Supreme Court says corporations have a constitutional right to advertise, even if that will harm public health. The outcome, however, is not a foregone conclusion. Twenty-five years ago, there were no constitutional protections for commercial speech. The tide can be turned back, beginning with a public demand that the Food and Drug Administration -- the leading U.S. public health regulatory agency -- assert the supremacy of protecting the public health over a purported constitutional right for corporations to hawk their wares.

EC -388