Regulating drug promotion to promote the public health: a response to Bennett et al.

Abstract

In Back to First Principles: A New Model for the Regulation of Drug Promotion, Alan Bennett and co-authors rightly argue that it is time for the U.S. Food and Drug Administration (FDA) to reconsider its scheme for regulating prescription drug promotion.1 Bennett and his co-authors assert that the FDA’s framework for overseeing prescriptiondrug promotion is outdated because itwas developedover 50 years ago when communication techniques and technologies, and First Amendment jurisprudence regarding protections for commercial speech, were appreciably different.2 Indeed, as Bennett and colleagues note, the FDA itself appears to agree that change, or at least clarification, may be warranted. For example, in recent years, the FDA has held or announced public meetings to solicit stakeholder input, announced a number of studies of drug promotion, and has issued several draft guidance documents intended to clarify certain aspects of its regulation of prescription drug promotion.3 Bennett and colleagues propose a ‘New Model’ to modernize the FDA’s regulatory scheme. The New Model would create three categories of drug manufacturer