Tuesday, February 9, 2010
Margaret Gilhooley, Seton Hall University School of Law, has published "Drug Safety and Commercial Speech: Television Advertisements and Reprints on Off-Label Uses." Here is the abstract.
This paper examines how the constitutional protections for commercial speech have limited the ability of Congress and FDA to regulate prescription drugs in ways that can affect safety. In Thompson v. Western States, the Supreme Court struck down a Congressional restriction on advertisements for unapproved “compound” drugs because a disclosure that FDA had not approved the compound was considered a constitutionally adequate alternative. While drug compounds are a relatively obscure category, the decision influenced Congress in deciding not to require a moratorium on television advertisements for newly approved drugs until the risks were better known.
The paper also provides an overview of the intense dispute about the legal and constitutional protections for manufacturers who distribute reprints to doctors of studies they fund about off-label uses of a drug with a disclosure about the lack of agency approval. At the end of the Bush Administration, FDA issued a Guidance Document that the agency did not intend to consider the non-promotional distribution of reprints about an off-label use by a company with disclosures about the lack of FDA approval as establishing an "intent" that the product be used for an unapproved use. While the agency position is ambiguous on whether it rests on statutory or constitutional grounds, or is an enforcement policy, if the new Administration were to revoke the Guidance, a constitutional challenge could ensue. That litigation could also test the difference between commercial speech and expressive speech that receives the highest First Amendment protections.
Justice Breyer, in his dissent in Western States, maintained that a "more lenient application" of the Constitution is needed and warned against "an overly rigid commercial speech doctrine" for Governmental decisions that affect "health and safety." Transforming these decisions into a constitutional decision "would involve a tragic constitutional misunderstanding" as shown by history with respect to the Due Process clause. Instead, for drugs and products that affect health, the test needs to be a "flexible" one that examines the restrictions "proportionality, the relation between restriction and objective, the fit between ends and means." This paper explores how a safety-aware proportionality test would apply to the areas where the commercial speech doctrine has limited FDA's ability to restrict drug promotion.
Download the paper from SSRN at the link.