As we know all too well, the U.S. Food and Drug Administration (FDA) has long taken the position that a medical device or drug manufacturer who promotes an FDA-approved device or drug for any unapproved uses violates the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA has claimed that such off-label promotion misbrands the product and circumvents the regulatory approval process that is in place to ensure that medical devices and drugs are safe and effective. Such circumvention, they have opined, risks putting the public in danger.
Drug and device manufacturers, on the other hand, have long believed that informing physicians about possible off-label uses helps doctors to make informed medical decisions that directly benefit patients. Manufacturers also believe that the FDA's ban on truthful and nonmisleading off-label promotion inhibits their First Amendment commercial free speech rights.
Courts have not always been kind to the FDA's view on the topic, however. Amarin, for example, held that the court's "considered and firm view is that ... the FDA may not bring [a misbranding] action based on truthful promotional speech alone, consistent with the First Amendment."
New Jury Instructions
Now, for the first time, the federal government is actively warming up to the idea that the law, specifically the FDCA, does not criminalize truthful off-label promotion. The Department of Justice has recently submitted jury instructions in a medical device case, part of which states, "[i]t is also not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device."
In making the decision to include such phrasing in the jury instructions, Richard Durbin, Jr., the United States Attorney for the Western District of Texas, points to both Amarin and Caronia cases, noting that the decisions "held that the misbranding provisions of the FDCA did not prohibit off-label promotion of FDA-approved prescription drugs that is solely truthful."
The particular case at hand, U.S.A. v. Vascular Solutions, Inc. & Howard C. Root, involves a medical device company and its CEO who were each charged with four counts of adulteration, four counts of misbranding, and felony conspiracy to: introduce adulterated medical devices into interstate commerce, introduce misbranded medical devices into interstate commerce, and defraud the United States by concerning the sale of the allegedly adulterated and misbranded medical devices.
In his proposed jury instructions, Mr. Durbin states that in order for the jury to find that Howard Root – the Vascular CEO – caused a "misbranding violation, [they] must find beyond a reasonable doubt that, by reason of his position in the corporation, he had the responsibility and authority either to prevent or promptly correct the violation, and that he failed to do so."
What Does This Mean?
While this may seem to be a promising change, medical device and drug manufacturers should continue approaching off-label promotion with caution for several reasons.
First, cases such as Amarin have limited geographic reach. Amarin is a decision handed down by the Southern District of New York, which means that should the FDA or other government agency bring a misbranding case in a different United States federal court, that other district court could come to a different conclusion, one that states that truthful and non-misleading off-label promotion is not protected by the First Amendment.
Second, there is no First Amendment safe harbor for false and misleading off-label promotion. Third, the idea that off-label promotion of a particular product is truthful and non-misleading will be decided on a case-by-case basis, dependent on the individual facts of the cases.
Companies should continue to take a cautious and measured approach to off-label promotion that will minimize the risk of the FDA and the DOJ concluding that their off-label promotion is false, misleading, or both. We continue to advocate for employee training in sales and marketing, implementing standard operating procedures that require formal review and approval of any and all promotional materials, and adhering to published FDA guidance.