FDA Drug Enforcement Actions

Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) monitoring of generic drug manufacturers, focusing on whether: (1) policies and procedures exist to ensure that manufacturers produce safe and effective products; (2) FDA is pursuing enforcement actions against manufacturers; and (3) manufacturing companies are aware of FDA standards for assessing their compliance with good manufacturing practices (GMP). GAO noted that: (1) FDA districts have discretion in dealing with manufacturers and training their investigators; (2) FDA lacks assurance that districts select and inspect manufacturers fairly and that districts forward recommendations for enforcement action to FDA headquarters; (3) FDA is developing certification criteria for drug investigators, since decentralized training does not ensure consistent inspections; (4) despite the potential for inconsistent inspections, there have been no inappropriate FDA inspection and enforcement actions; and (5) manufacturers are generally aware of the standards that FDA uses to determine GMP compliance.