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), drug supply chain issues, 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).

While at FDA, Mr. Godfrey most recently was a Senior Regulatory Counsel in the Center for Tobacco Products, Office of Regulations, and also served as the Special Assistant/Senior Counsel to the Deputy Commissioner for Medical Products and Tobacco in the Office of the Commissioner. 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 Deputy Commissioner for Medical Products and Tobacco.

Prior to these roles, 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.

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.
  • 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.
  • 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

Recent Congressional Efforts to Address the Cannabis Policy Gap
Advisory
Questions & Answers Guide to FDA’s Prescription Drug Importation Proposals
Advisory
Ready or Not, Here It Comes! The Drug Supply Chain Security Act Requirements Are Almost Fully Upon Us. Are You Prepared?
Food and Drug Law Institute
Effective and Meaningful Fair Balance/Risk Disclosure
Speaker, Food and Drug Law Institute, Advertising and Promotion for Medical Products Conference, Washington, DC
The Road Ahead: Public Policy Priorities Post-SAFE Banking & Public Safety Issues
Speaker, NCIA's California Cannabis Business Conference, Long Beach, CA
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 Regulatory Counsel, Center for Tobacco Products (CTP), US Food and Drug Administration
  • Senior Counsel/Special Assistant to the Deputy Commissioner for Medical Products and Tobacco, US Food and Drug Administration
Activities
  • Editor, Journal of Health Law
Overview

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