Bryant Godfrey is a partner in Foley Hoag’s Washington, D.C. office, where he provides strategic regulatory advice to large pharmaceutical, medical device and biotech companies, start-ups, 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. He has a deep understanding of the issues that are of utmost importance to his clients, and he helps them to foster positive relationships with the Agency.
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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, medical device reporting, FDA warning letters and responses, dispute resolution, FDA inspections, recalls, administrative detention, import alerts and refusals, combination products, cannabis-derived products, foods/dietary supplements, cosmetics, digital health (including artificial intelligence and machine-based learning technologies) and gene and cellular therapies.
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.
Bryant also served as the Special Assistant/Senior Counsel to the Principal Deputy Commissioner in the Office of the Commissioner, and spent time as a Senior Regulatory Counsel in the Center for Tobacco Products, Office of Regulations. In these roles, he, among other things, established regulation policy for both medical products and tobacco products and wrote and contributed to the writing of various regulations, guidance documents, and other regulatory documents; managed Agency clearance of the same; and directed special projects, studies, or activities of concern to the Commissioner and/or Principal Deputy Commissioner.
