Jeremiah J. Kelly
Jeremiah’s practice includes overall regulatory strategy, support to investigational new drug applications (INDs) or investigational device exemptions (IDEs), and support to pre-market applications (505(b)(1) and (b)(2) NDAs, BLAs, EUAs for drugs and biologics, as well as 510(k)s, PMAs, and De Novo Requests for medical devices) and GxPs. He advises on expedited approval mechanisms, Hatch-Waxman and BPCIA regulatory frameworks, regulatory incentives (e.g., marketing exclusivity and priority review vouchers), product labeling, risk evaluation and mitigation strategies (REMS), advertising and promotion, response to FDA compliance actions (e.g., negative 482 or Warning Letters), and input and challenges to FDA rulemaking under the Administrative Procedures Act (APA). He helps companies shape legislative changes to the Federal Food, Drug, and Cosmetic (FD&C) Act and the Public Health Service Act (PHSA).
Jeremiah’s practice also includes unique expertise in agreements with the research and development (R&D) elements of the federal government. He has drafted and negotiated cooperative research and development agreements (CRADAs), Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation (DFAR) contracts, grants and cooperative agreements, other transaction agreements (OTAs), experimental supply agreements, and patent license agreements to create “win-win” collaborations between industry and the government.
As the chief of the FDA Regulatory Law Division, JAG, USAMRDC, Jeremiah advised USAMRDC and the Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Nuclear and Radiological Defense (JPEO-CBRND) on the development and regulation of medical countermeasures to treat the unique needs of the U.S. soldier. During the COVID-19 pandemic, he served as the chief coordinating counsel of the DoD JPEO-CBRND Joint Assisted Acquisition (JA2) Legal Cell, managing, staffing, and negotiating over $83 billion in COVID vaccine, therapeutic, and diagnostic capabilities for the federal government’s COVID-19 response. Prior to his DOD service, Jeremiah spent over seven years in the FDA Commissioner’s Office in the Office of the Chief Counsel (OCC) and the Office of Legislation (OL) and three years as a litigator at a large private sector law firm.
Related Practices
Experience
Government Experience
- Chief, FDA Regulatory Law Division, Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Development Command (USAMRDC)
- Chief Coordinating Counsel, JPEO-CBRND Joint Assisted Acquisition COVID-19 Legal Cell
- Attorney, Medical Product Development & Regulation, JAG, USAMRDC
- Office of the Chief Counsel, Office of the Commissioner, U.S. Food and Drug Administration
- Office of Legislation, Office of the Commissioner, U.S. Food and Drug Administration
Insights
Credentials
Education
- J.D. University of Maryland School of Law 2008
- Master of Public Policy George Washington University 2003
- B.A. Political Science McDaniel College 2001
Bar Admissions
- District of Columbia
- Maryland
Court Admissions
- U.S. Court of Appeals for the Fourth Circuit
- U.S. District Court for the District of Maryland
Professional Memberships and Activities
- Food and Drug Law Institute
- Member, Medical Products Committee
- Former member, Editorial Advisory Board, Food and Drug Law Journal
- Lecturer, Therapeutic Product Development/Generics & Biosimilars/ Medical Device Development, Northeastern University Master’s Program in Regulatory Affairs, College of Professional Studies
- Adjunct Professor, Biotechnology & FDA Regulations/Drug and Biologics Compliance/International Regulations, Master of Science in Biotechnology and Management Program, Mount St. Mary’s University
- Phase III Project Management Certification, U.S. Naval Postgraduate School
- Regulatory Affairs Certification (RAC), Regulatory Affairs Professional Society (RAPS)
Recognition
- Food and Drug Law Institute (FDLI), Distinguished Service and Leadership Award, 2019
- The Judge Advocate General (TJAG), U.S. Army, Legal Service Award for Excellence, 2021 (only one of three awarded annually, earned for outstanding legal support of Operation Warp Speed (OWS) and the COVID-19 response)
- United States Army General Gustave F. Perna, Four-Star Note of Commendation, 2020 (Awarded for exceptional contribution to Operation Warp Speed (OWS) the response to COVID-19)
- U.S. Army Medical Research & Development Command (USAMRDC)
- Meritorious Civilian Service Medal, 2021, 2022 (Awarded in 2021 for legal support during the COVID-19 pandemic and in 2022 for support to obtain FDA approval of Intravenous Artesunate and Award of a Priority Review Voucher)
- Wolfpack Award, 2021 (Earned for contributions to the Additive Manufacturing Working Group in response to the COVID-19 pandemic)
- U.S. Army Superior Civilian Service Award (awarded at FDA approval of tafenoquine for severe malaria)
- Department of the Army Commander’s Award for Civilian Service, 2015, for contributions to FDA Clearance of Leishmania Rapid Diagnostic Device
- Federal Laboratory Consortium, Excellence in Technology Transfer Award, 2019 (Awarded for legal counsel in support of New Drug Application (NDA) approval for tafenoquine antimalarial)
- Office of the Commissioner, U.S. Food and Drug Administration
- Special Citation from the Director of the Center for Drug Evaluation and Research (2005)
- FDA Commissioner’s Group Recognition Award: Office of Legislation Drugs Team (2003)
Community
Volunteerism
- Coach, Mountain Valley Little League and Babe Ruth Baseball, 2015 – present
- Coach, Upward Basketball, 2010 – present
- Frederick Church of the Brethren (Member 1996 – present; Chair and Vice Chair of Leadership Team, 2021-Present)
- Co-chairman, Band of Brothers Men’s Ministry, 2012 – present
- Mission of Mercy Mobile Medical Facilities, 2018 – 2021
- Mentor, Maryland Freestate Challenge Program for at-Risk Youth, 2012 – 2014