Having spent nearly a decade at the US Food and Drug Administration (FDA) in senior regulatory and policy roles, Bryant M. Godfrey advises FDA-regulated companies on a broad range of FDA regulatory, policy, compliance, enforcement, and strategic matters. Mr. Godfrey has a deep understanding of the issues that are of utmost importance to his clients, and he helps his clients to foster positive relationships with the agency. 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, post-marketing commitments and requirements, 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, tobacco 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, Mr. 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. While in OPDP, Mr. Godfrey also authored and co-authored several guidance documents relating to prescription drug promotion, off-label communications, and social media, and he helped the office to respond to various First Amendment challenges brought by regulated industry. Mr. Godfrey also participated on various Agency-wide First Amendment working groups to examine and assess current vulnerabilities as well as potential paths forward.

Mr. 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. 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.

During his time at FDA, Mr. Godfrey received an FDA Commissioner's Group Recognition Award for his involvement with the Bad Ad program and an FDA/CTP Collaboration Award for his efforts in working with and coordinating multiple agency components during the development of the tobacco product jurisdiction rule.

Prior to FDA, Mr. Godfrey practiced as an attorney in the health regulatory group of a national law firm in its Washington, DC office. While in law school, he was a dean's scholar, and served for two years as a Lead Articles Editor of the Journal of Health Law (now, the Journal of Health & Life Sciences Law), a publication of the American Health Lawyers Association.

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.

Perspectives

Understanding the Biden Administration's Potential Impact on Consumer Products
Federal Regulatory Trends in Consumer Health
Understanding the Scope of FDA Enforcement Authority and Actions
Speaker, FDA Boot Camp, The American Conference Institute
Preparing for 2021: Food and Drug Administration and Related Regulatory Challenges
Arnold & Porter Webinar
The Implications of the Biden Administration's Plan to Reschedule
Presenter, Marijuana Policy Project and the National Cannabis Industry Association, Virtual Public Policy Summit
More

Credentials

Education
  • JD, Saint Louis University School of Law
  • Health Law Certificate, Saint Louis University School of Law
  • MHA, Saint Louis University College for Public Health and Social Justice, with distinction
  • BA, Washington University in St. Louis
Admissions
  • District of Columbia
Government & Military Service
  • 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
Activities
  • Member, Food and Drug Law Institute (FDLI)
  • Member, National Cannabis Industry Association (NCIA), Policy Council
  • Lifetime Member, FDA Alumni Association
  • Fellow, Leadership Council on Legal Diversity (LCLD)
  • Co-Chair, FDLI Advertising & Promotion Conference Planning Committee (2021)
Overview

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