Godfrey

Bryant M. Godfrey

Partner
Co-Chair, FDA Practice
Washington, DC

My collaborative approach to helping clients navigate the FDA regulatory landscape provides results-oriented solutions to their most pressing problems.

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. 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.

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. 

Education

  • Saint Louis University School of Law, J.D., 2007
  • Saint Louis University College for Public Health and Social Justice, M.H.A., with distinction, 2007
  • Washington University in St. Louis, B.A., 2002

Bar and Court Admissions

BAR ADMISSIONS
  • District of Columbia

Experience

  • Represents trade associations and individual member companies in rulemaking and guidance development proceedings before FDA.
  • Represents prescription drug manufacturers in addressing OPDP regulatory letters, inquiries, and advisory comments and advising on promotional issues for brands across therapeutic areas.
  • Serves as the legal representative on promotional review committees for pharmaceutical and medical device manufacturers.
  • Regularly prepares (as well as provides defensive responses to) competitor demand letters, and drafts letters to OPDP on behalf of companies desiring to challenge misleading promotional claims made for competitor products.
  • Counsels academic research institutions on various FDA and CLIA requirements pertaining to the design and use of and testing with institution-developed in vitro diagnostics for treatment purposes.
  • Counsels academic research institutions on the development of medical devices and associated FDA regulatory requirements.
  • Counsels companies on FDA regulatory strategies and considerations for digital health products.
  • Counsels drug, biologic, and medical device manufacturers on various FDA import and export regulatory requirements, including reimportation and import detentions.
  • Provides FDA regulatory and policy advice and strategic counsel to stakeholders within the legal cannabis industry in the areas of clinical research, foods/dietary supplements, and cosmetics.
  • Counsels drug manufacturers on PDMA regulatory and compliance issues (including reporting obligations).
  • Assists manufacturers in responding to Warning Letters and Form FDA-483s.
  • Assists drug and medical device manufacturers with all phases of product recalls.
  • Performs regulatory due diligence in connection with various transactions involving pharmaceutical, biotechnology, and medical device companies.
  • Assists FDA-regulated companies in requesting and strategically preparing for meetings with FDA.

PROFESSIONAL EXPERIENCE
  • Senior Lead Regulatory Counsel, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration
  • Senior Counsel/Special Assistant to the Principal Deputy Commissioner, US Food and Drug Administration
  • Senior Regulatory Counsel, Center for Tobacco Products (CTP), US Food and Drug Administration

Honors & Involvement

HONORS
  • The Best Lawyers in America: Ones to Watch, Health Care Law
  • FDA Commissioner's Group Recognition Award
  • FDA/CTP Collaboration Award
  • Saint Louis University School of Law Journal of Health Law (a former publication of the American Health Lawyers' Association), Lead Articles Editor
INVOLVEMENT
  • Member, National Bar Association 
  • Member, Washington Bar Association
  • Co-Chair, FDLI Advertising & Promotion Conference Planning Committee (2021)
  • Fellow, Leadership Council on Legal Diversity (LCLD)
  • Lifetime Member, FDA Alumni Association
  • Member, National Cannabis Industry Association (NCIA), Policy Council
  • Member, NCIA, Scientific Advisory Committee
  • Member, Food and Drug Law Institute (FDLI)

Speaking Engagements

  • “Promoting Diversity and Inclusion Through Advertising and Promotion,” 2022 FDLI Advertising and Promotion for Medical Products Conference (October 2022)
  • Moderator, "Best Practices to Ensure Compliance with FDA Guidance on Label-Consistent Drug Promotion," Promotional Review Committee Compliance & Best Practices event (September 2022)
  • The ABCs of Prescription Drug Promotion,” Foley Hoag Webinar (March 2022)
  • "Committee Insights: Cannabis and COVID-19 - What We Know and What We Don’t," National Cannabis Industry Association (March 2022)
  • "Planning for Launch: Navigating the Office of Prescription Drug Promotion's Core Launch Review Process," 2021 FDLI Advertising and Promotion for Medical Products Conference (October 2021)