DOJ: Device Manufacturers Can Relay ‘Truthful’ Info on Unapproved Uses

Regulatory NewsRegulatory News | 19 January 2016 |  By 

A US Department of Justice attorney for the first time explained in a set of jury instructions that it is legal for a device company or its sales representatives to provide doctors with “wholly truthful and non-misleading information” about off-label medical device uses.

The jury instructions, filed earlier this month by Richard Durbin, Jr., the US Attorney for the Western District of Texas, explain what speech is illegal under the Food, Drug, and Cosmetic Act (FDCA) in the medical device case of US v. Vascular Solutions, Inc.

In making this declaration for jurors on off-label marketing, Durbin points to both the Amarin and Caronia cases – landmarks in off-label trials -- noting 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.”

Insiders say this could be the first time the DOJ has abandoned the idea that truthful off-label promotion can be criminal.

The heart of the battle deals with whether the US Food and Drug Administration (FDA) can regulate what companies can say about approved products and their uses off-label, and whether companies under the First Amendment have the right to discuss the use of such products not authorized by FDA if those uses are considered truthful.

In the case of Amarin, which FDA lost, the agency was barred from preventing the company from conducting "truthful and non-misleading speech promoting the off-label use of Vascepa." Similarly, in the case of Caronia, the US 2nd Circuit Court of Appeals found that the government cannot stifle free speech to advance a questionable public good.

In this particular case, however, Vascular Solutions is charged with introducing misbranded devices into interstate commerce as it’s alleged that Vascular’s off-label use claims were misleading and false. The indictment alleges that Vascular Solutions encouraged salespeople to market its Vari-Lase laser treatment as targeting perforator veins, even though FDA refused to approve it for that use.

Durbin writes that in order for the jury to find that Vascular CEO Howard Root “caused a misbranding violation, you 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.”

The US Chamber of Commerce has already said it does not believe the charges will trump Vascular's First Amendment rights.

Proposed Jury Instructions

Reed Smith


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy