The Misuse of the FCA to Enforce cGMP (Current Good Manufacturing Practice) Violations

Abstract

Since the civil False Claims Act (“FCA”) was amended in 1986, the statute has evolved into a seemingly limitless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Whether or not using one statute to enforce another is sound jurisprudence is another issue, however. In the field of health care, for example, the safety and effectiveness of drugs and devices is typically regulated by the Food Drug and Cosmetic Act (“FDCA”). Nonetheless, the FCA has been used recently in actions where the allegations include off-label promotion of drugs, kick-backs, and violations of good manufacturing practices (“cGMP”) by linking the alleged violation with the government reimbursement under Medicare and Medicaid. In particular, using the FCA to allege violations of cGMP is fraught with problems.