title: Back to first principles: a new model for the regulation of drug promotion.
abstract: The US Food and Drug Administration's ('FDA' or the 'Agency') current regulatory framework for drug promotion, by significantly restricting the ability of drug manufacturers to communicate important, accurate, up-to-date scientific information about their products that is truthful and non-misleading, runs afoul of the First Amendment and actually runs counter to the Agency's public health mission. Our article proposes a New Model that represents an initial proposal for a modern, sustainable regulatory framework that comprehensively addresses drug promotion while protecting the public health, protecting manufacturers' First Amendment rights, establishing clear and understandable rules, and maintaining the integrity of the FDA approval process. The New Model would create three categories of manufacturer communications-(1) Scientific Exchange and Other Exempt Communications, (2) Non-Core Communications, and (3) Core Communications-that would be regulated consistent with the First Amendment and according to the strength of the government's interest in regulating the specific communications included within each category. The New Model should address the FDA's concerns related to off-label speech while protecting drug manufacturers' freedom to engage in truthful and non-misleading communications about their products.
authors: Alan Bennett is a Life Sciences senior counsel in Ropes & Gray's Washington office.
authors: Alan
authors: A
authors: Bennett
authors: Freddy Jiménez is an Assistant General Counsel at Johnson & Johnson in New Brunswick, New Jersey.
authors: Freddy
authors: F
authors: Jiménez
authors: Larry Fields is Senior Director, Clinical Development, Janssen Pharmaceuticals, Inc.
authors: Larry Eugene
authors: LE
authors: Fields
authors: Joshua Oyster is a Life Sciences associate in Ropes & Gray's Washington office. The views expressed are solely those of the authors and may not necessarily represent those of their employers or clients. The authors wish to acknowledge Kristen Klesh and Julie Dorais for their drafting support on earlier versions of this manuscript.
authors: Joshua
authors: J
authors: Oyster
keywords: FDA regulation; First Amendment; drugs and devices; off-label enforcement; promotion; regulatory framework; scientific exchange