cGMP Violations Should Not Be Used as a Basis for FCA Actions Absent Fraud

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the alleged violation with the government reimbursement under Medicare and Medicaid. cGMP violations, however, are historically enforced by the Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic Act (FDCA), which regulates the safety and effectiveness of drugs and devices. Whether alleged cGMP violations are subject to enforcement by the FDA under the FDCA or by the DOJ and private citizens on behalf of the United States government under the FCA, or both, has been heavily debated recently. This Article examines the statutory background of cGMPs and quality system regulations, considers enforcement of cGMP violations by both the FDA under the FDCA and the DOJ under the FCA, and proposes that fraudulent and felonious violations of cGMPs should be enforced by the DOJ under the FCA because DOJ has the resources and the expertise to investigate and prosecute such violations. Non-fraudulent cGMP violations, on the other hand, should be enforced by the FDA under the FDCA because the FDA has both the subject matter expertise and the statutory mandate to regulate drugs and medical devices