FDA Takes New Look At Food, Drug Advertising Restrictions
July 7, 2008 - 8:29 PM
(CNSNews.com) - Should drug companies be limited in the way they advertise the health benefits of certain foods, dietary supplements and prescription drugs? After a string of adverse court decisions favoring free speech, the Food and Drug Administration (FDA) is re-considering those restrictions.
The outcome is likely to rile either those who favor free speech and consumer choice or proponents of strong government regulation designed to protect unwitting consumers.
Trying to salvage its credibility, the FDA in May took the unusual step of inviting public comment on whether its regulations, guidance policies and practices comply with First Amendment case law.
The comment period ended on Sept. 13, and responses to the comments are due Monday.
The agency has acknowledged that the Supreme Court, as well as lower courts, has become increasingly sympathetic to First Amendment concerns. Commercial speech is also constitutional, according to the Supreme Court, as long as it is truthful and not misleading.
In April 2002, the Supreme Court in Thompson v. Western States Medical Center, struck down FDA restrictions on the advertising of particular "compounded" drugs, which are FDA-approved drugs that are mixed together by pharmacists in order to meet the needs of a particular patient.
In that decision, the high court reasoned that even if the restriction on speech directly advanced government's interest in maintaining the integrity of FDA's new drug approval process, FDA could have found other means to that end such as mandated labels or disclosure requirements.
Pfizer, Inc. has argued that open access to information is "at the core of the First Amendment." Pfizer lawyer Arnold Friede, speaking at a Friday forum hosted by the Federalist Society, lamented the "enormous loss of agency credibility in the courts" and warned that the integrity of the FDA drug approval process is at stake.
It's not FDA's role in reviewing drug efficacy or manufacturer claims, Pfizer contends, but an "old, paternalistic tradition" that leads the agency to restrict "a vibrant flow of information" that could help patients and doctors make more informed health care decisions.
But Bruce Silverglade of the liberal Center for Science in the Public Interest (CSPI) said he is "very concerned" that the FDA's decision to re-think its regulatory zeal is politically motivated. Silverglade, as well as former FDA commissioner David Kessler, suggests that FDA is jeopardizing public health in response to efforts by conservative judges, academics and advocacy groups looking to use the courts to achieve deregulation.
It's a "license to practice quackery," Silverglade warned.
Consumer groups like CSPI have also warned that unrestricted direct-to-consumer advertising will drive up drug prices and unnecessarily boost consumer demand for prescription drugs.
Previous court decisions curtailing FDA speech restrictions include the 1999 D.C. Circuit decision in Pearson v. Shalala regarding dietary supplements and a series of cases brought by the Washington Legal Foundation regarding the dissemination of "off-label" drugs (later reversed by an appeals court solely on procedural grounds).
FDA spokesperson Laura Bradbard did not return calls seeking comment.
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