Bryant Godfrey

Partner - Washington, D.C.

Bryant Godfrey

Contact Information

202.261.7393

202.467.9675

bgodfrey@foleyhoag.com Download vCard

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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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

Languages:

English

Representative 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

  • 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

  • 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)
     
 
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Bar Admissions

  • District of Columbia