The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label promotions).
FDA has broad authority to proscribe the content of product labeling and impose restrictions on the off-label promotion of drugs, medical devices and other regulated products. However, the First Amendment to the US Constitution and other laws restrict the extent to which FDA can prohibit truthful and non-misleading statements about unapproved or off-label uses of such products. Despite well-established constitutional protections on the dissemination of scientific speech and truthful and non-misleading commercial speech, the number of prosecutions, indictments and settlements arising from off-label promotion of drugs and medical devices has increased significantly in the past ten years. The number of warning letters related to unapproved use of medical devices and off-label claims for drugs has also increased in the same timeframe. Manufacturers and other stakeholders have called for additional guidance and greater limits on FDA’s application of speech-related enforcement principles, such as the “intended use” doctrine, to hold companies liable for the dissemination of truthful and non-misleading claims regarding off-label uses or unapproved uses of medical devices and other products.
In response to recent speech-related court decisions such as United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) (holding that the government may not prohibit or criminalize truthful off-label promotional speech); Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015) (holding that the government may not pursue misbranding provisions under the Federal Food, Drug and Cosmetic Act for statements that were truthful and non-misleading); and United States v. Vascular Solutions, Inc., Cr. No. 14-926 (W.D. Tex. 2016) (jury finding that speech that is “solely truthful and not misleading” cannot be basis for misbranding charge), FDA is requesting public comment on the regulation of manufacturer communications regarding off-label or unapproved uses of approved medical products. FDA intends to address and prioritize “Manufacturer Communications Regarding Unapproved, Unlicensed, or Uncleared Uses of Approved, Licensed, or Cleared Human Drugs, Biologics, Animal Drugs and Medical Devices” in a guidance document.
The agency is requesting comments from stakeholders on the following broad questions:
(1) How increased off-label promotions could impact public health, and whether the impact would differ across different categories of medical products
(2) The extent to which increased off-label promotion would affect incentives for firms to seek FDA approval or clearance for new uses
(3) The effect of increased availability of information regarding unapproved uses on firms’ incentives to seek FDA approval or clearance for new uses
(4) Standards the agency should apply to off-label communications to minimize the potential that they are misleading or harmful
(5) Factors the agency should consider in evaluating whether off-label promotions are truthful and non-misleading
(6) Whether firms should disclose data from human studies to ensure quality and integrity of communications and scientific information, and how transparency of this information should be monitored
(7) How the agency should monitor off-label promotions and what actions it should take with respect to those that are false or misleading or otherwise raise public health issues
(8) Changes FDA should consider to 21 C.F.R. §§ 201.128 and 801.4 pursuant to its notice of proposed rulemaking
The hearing is an important step in what will undoubtedly be a longer-term process of reconciling FDA’s product approval process and speech restrictions with evolving First Amendment precedent. The hearing is a meaningful opportunity for manufacturers, marketers and other stakeholders to provide information, data and feedback to FDA on critical issues that will shape future policies on marketing communications. Comments may be submitted online.
Important Dates and Information
Registration Deadline: October 19, 2016
Public Hearing Dates: November 9 and 10, 2016
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Great Room (Rm. 1503)
Silver Spring, MD 20993