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DOJ Position on Off-Label Promotion: What’s Changed and What’s the Same

It is well known that the U.S. Food and Drug Administration (FDA) has long taken the position that a medical device or drug manufacturer who promotes any unapproved uses of FDA-approved devices/drugs is in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA has asserted that off-label promotion leads to misbranding of the product and circumvention of the regulatory approval process that is taken to ensure product safety and efficacy. On the other hand, recently, the courts have sided with the manufacturers where it was ruled that the FDA may not bring action based on truthful promotional speech. See, Amarin Pharma, Inc. v. U.S. Food & Drug Admin., 119 F.Supp.3d 196 (S.D.N.Y. 2015). 

In this vein, the Department of Justice (DOJ) has shown some degree of reluctance to bring cases, including qui tam actions, stemming from off-label promotion despite their wide discretion in investigating and prosecuting cases at will. Furthermore, the DOJ has recently submitted jury instructions in a medical device case, part of which indicates that it is not a crime to give doctors wholly truthfuland non-misleading information. See, United States v. Vascular Solutions, Inc., No. SA-14-CR-926, 2016 WL 5475999 (W.D. Tex. Jan. 27, 2016)

However, the DOJ, in presenting its recent prosecution trends during a conference in December 2018, indicted that it will likely exercise its power to prosecute off-label promotion cases when there exist “false and misleading” information and/or a “public health concern.”  It also indicated that it would investigate and likely prosecute such cases if off-label promotion is in fact driving kickbacks in any shape or form.  It should be noted that the aforementioned cases are limited to each jurisdiction in which the case was decided. In other words, government agencies including FDA are not barred from bringing a misbranding case in different federal courts throughout the states and in doing so, may ultimately lead to different rulings. Ironically, but understandably, FDA permits physicians to prescribe and use medications outside of the label:

The legislative history of the FD&C Act indicates that the Congress did not intend FDA to interfere with the practice of medicine. Thus, once a drug is approved for marketing, FDA does not generally regulate how, and for what uses, physicians prescribe that drug. A physician may prescribe a drug for uses or in treatment regimens or patient populations that are not listed on the FDA-approved labeling.  See Statement by William B. Schultz, Deputy Commissioner for Policy, FDA, before the Committee on Labor and Human Resources, United States Senate, February 22, 1996.

This comports with physicians’ prescribing practice. Historically, physicians are allowed to use their clinical discretion and professional judgment as part of their regular course of practice. In doing so, they are permitted to use and prescribe medications “off-label” to establish proper patient care, provided it is consistent with the appropriate standard of medical care. 

Drug manufacturers and distributors must continue to take a cautious approach with respect to any activity that could be construed as off-label promotion and labeling, regardless of the material’s veracity. Contact Frier Levitt today to speak to an attorney about issues with off-label promotion and current FDA policy and regulations.