Former Senior Lead Regulatory Counsel at the U.S. Food and Drug Administration (FDA), Bryant Godfrey, has joined Foley Hoag LLP as a partner in the Healthcare and Life Sciences practice groups. He is resident in the firm’s Washington D.C. office where he will advise FDA-regulated companies on a broad range of FDA regulatory, policy, compliance, enforcement and strategic matters.
“With the addition of Bryant Godfrey, Foley Hoag continues to enhance its regulatory capabilities and its healthcare and life sciences practices,” said Areta Kupchyk, partner and co-chair of Foley Hoag’s Administrative Law Department and FDA Practice. “Bryant has a deep understanding of the regulations and policies that are of utmost importance to clients, and he helps them to foster positive relationships with the FDA. We welcome him to the firm.”
Godfrey spent nearly a decade at the FDA in senior regulatory and policy roles. His 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, and post-marketing commitments. His work also includes counseling clients on matters related to Current Good Manufacturing Practice (CGMP) regulations, Clinical Laboratory Improvement Amendments (CLIA), drug supply chain requirements, and medical device reporting. Godfrey is also well versed in assisting clients with FDA enforcement and compliance matters, including warning letters, dispute resolution, recalls, administrative detention, and import alerts and refusals. In addition, his practice extends to combination products, cannabis-derived products, foods, dietary supplements, cosmetics, and digital health.
While at the FDA, Godfrey 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.
Godfrey 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.
Before joining Foley Hoag, Godfrey served as counsel at Arnold & Porter LLP. He earned a Bachelor of Arts from Washington University in St. Louis, a Master of Health Administration with distinction from the Saint Louis University College for Public Health and Social Justice, and a Juris Doctorate from Saint Louis University School of Law.