DOJ Uses False Claims Act to Enforce FDA Manufacturing Rules

On January 12, 2017, the US Department of Justice announced it had reached a global settlement with Baxter Healthcare Corporation. The civil component of the settlement was atypical of other False Claims Act (FCA) matters. It was small by comparison -$2.158 million – and it was not based on off-label promotion or kickback activities. Instead, the Baxter settlement was based on an allegation that Baxter violated current good manufacturing practices (cGMP), a prohibited act under the Federal Food, Drug, and Cosmetic Act (FDCA). At any given time, a company is violating cGMP; by their very nature, “current-practices are constantly evolving. FDA has the statutory authority to enforce cGMP requirements, or to exercise its enforcement discretion” not DOJ.