Bryant Godfrey
Board of Directors
Bryant Godfrey is a partner in the Washington, D.C. office of Foley Hoag and is Co-Chair of the firm’s FDA Practice Group. He provides strategic regulatory advice to large pharmaceutical, medical device and biotech companies, startups, and trade associations, helping them to navigate challenges relating to the development, manufacturing, approval and promotion of drugs, biologics, medical devices, and combination products. Having spent nearly a decade at the US Food and Drug Administration (FDA) in senior regulatory and policy roles, Bryant advises FDA-regulated companies on a broad range of FDA regulatory, policy, compliance, enforcement and strategic matters.
Bryant's experience encompasses a wide range of issues relating to product jurisdiction, medical product development and approval/clearance, labeling, advertising and promotion, scientific exchange, investigations of off-label marketing, post-marketing commitments and requirements. His work also includes Current Good Manufacturing Practices (CGMPs), Clinical Laboratory Improvement Amendments (CLIA) compliance, drug supply chain, FDA inspections, recalls, cannabis-derived products, and foods/dietary supplements.
While at FDA, Bryant was the Senior Lead Regulatory Counsel in the Center for Drug Evaluation and Research, Office of Medical Policy, Office of Prescription Drug Promotion (OPDP), where he led the regulatory counsel team within OPDP and advised the office on a wide range of complex legal, regulatory, and policy matters relating to the promotion of prescription drug products. While in OPDP, he helped the office to respond to various First Amendment challenges brought by regulated industry. Bryant also participated on various Agency-wide First Amendment working groups to examine and assess current vulnerabilities as well as potential paths forward.