The First Amendment And The Emerging Tort Of Off-Label 'Promotion'

INTRODUCTION

In the wake of U.S. Supreme Court rulings finding personal injury failure to warn claims preempted by the Food and Drug Cosmetic Act (FDCA), new state law tort theories are emerging. None may be more potently poised to alter the medical product litigation landscape than purported state law tort claims for "off-label promotion." As the courts reexamine the power granted to the Food and Drug Administration (FDA) and limit the scope of its enforcement in light of Due Process and First Amendment considerations, state tort claims may find a new footing in the emerging void.

The FDA places restrictions on what, when, where, why, and who may disseminate information concerning regulated products. Over decades, the statutory and regulatory framework has expanded, placing more restrictions on information that may be disseminated. This expanding regulatory framework continually inches closer to infringing on constitutional protections. As enforcement and market competition increase, the tension among regulated industry, the regulators, the medical profession, and the consuming public has likewise increased.

Increasingly aggressive enforcement of marketing claims under the FDCA has ushered in a new era and a fresh look at how the FDA enforces rules governing labeling and the dissemination of truthful scientific and medical information concerning FDA-regulated products. Nowhere is the impact of this enforcement effort more profoundly focused than in connection with criminal and civil penalties for communicating reliable scientific and medical information, prosecuted and punished under the law as "unapproved" drugs and devices (i.e., "off-label promotion").

Off-label use presents a conundrum: Physicians, consumers, and even academia are unrestrained in recommending any product for any use, irrespective of whether there is scientific or medical support for the use. Manufacturers with reliable scientific and medical information regarding a use not in the FDA-approved labeling are throttled under the rubric of off-label promotion, and silenced or prosecuted. From this conundrum, an urgent moral and ethical imperative exists to provide more - not less - reliable scientific and medical information.

The provision of medical care implicates a number of stakeholders - manufacturers, health care providers, consumers, and government.1 The interplay among the stakeholders creates a discernible matrix. Manufacturers have varying degrees of knowledge concerning post-market experience and methods of disseminating information. Physicians' sophistication with regards to off-label uses and their motivation for doing so varies significantly as well. Consumers' understanding ranges from highly educated concerning the products they use to existing at the mercy of their doctors. The FDA sits in judgment of how the manufacturer informs health care providers and, increasingly, the public, through a set of rules, guidances, draft guidances, and policies that permit the exercise of discretion by the government to determine whether truthful medical and scientific information constitutes "false" information and evidence of criminal conduct. This complex matrix is on a collision course with fundamental Due Process and First Amendment principles. These constitutional underpinnings are increasingly poised to serve a vital role in furthering the public health and restricting the scope of government control and power, but with the right and financial incentive to speak, new obligations, duties and claims may arise.

1. FDA'S MISSION

   In establishing the FDA, Congress set the "mission" of the FDA to:

   promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;2

   protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled... drugs are safe and effective... there is reasonable assurance of the safety and effectiveness of devices... cosmetics are safe and properly labeled....;3

   ...reduce the burden of regulation, harmonize the regulatory requirements, and achieve reciprocal arrangements [with other nations];4 and

   ...carry out [its mission] in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.5

   In defending the increasing regulatory landscape of the FDA, the commissioner has stated:

   Now I know that in...