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

Kyle Faget, Clinical Compliance Counsel, Boston Scientific Corporation, USA

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.

Kyle Faget is a graduate of the University of Michigan Law School and currently Counsel at Boston Scientific Corporation, and worked as an associate in Government Enforcement at Ropes & Gray LLP prior to going in-house.

Boston Scientific Corporation (abbreviated BSC), is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a range of interventional medical specialties, including interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology.