Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful and often the standard of care in fields such as oncology and pediatrics. Indeed, Congress requires federal health care programs like Medicare and Medicaid to cover and reimburse "medically accepted" off-label uses. On the other hand, FDA regulations bar drug makers from promoting their products for off-label use, and the Justice Department has aggressively used the False Claims Act (FCA) to punish off-label promotion indirectly.
A federal district court in California is now considering an FCA action that could have implications for the First Amendment protection accorded to truthful off-label promotion. In U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc., the relator alleges that defendants Millennium Pharmaceuticals and Schering-Plough Corporation (now part of Merck & Co.) promoted a heart-disease drug for off-label use and thereby caused the submission of false claims. In its motion to dismiss, Merck argued that the FCA cannot, consistent with the First Amendment, be interpreted to impose liability for disseminating truthful, non-misleading scientific information about drugs.(1) Merck noted that the Supreme Court previously struck down restrictions on drug manufacturer's promotional activities in Sorrell v. IMS Health, Inc.,(2) and that the Second Circuit held inUnited States v. Caronia(3) that the Food, Drug, and Cosmetic Act cannot, in light of the First Amendment, be construed to ban a manufacturer's truthful, non-misleading speech about off-label uses. Building on these precedents, Merck argued that the FCA should be interpreted to avoid constitutional difficulties that the relator's theory of liability raises.
In response to Merck's pending motion to dismiss, the U.S. Department of Justice submitted a statement of interest arguing that truthful promotion can be used as a basis for FCA liability.(4) PhRMA submitted an amicus brief forcefully responding to that argument.(5) With the First Amendment issues fully briefed, it is possible that the district court could dismiss the relator's complaint in whole or in part based on constitutional considerations. Millennium Pharmaceuticals is clearly a case to watch.