Nathan A. Brown is a partner in the health care and life sciences practice who focuses on food and drug law and health care reimbursement and regulatory issues.
Practice & Background
Mr. Brown advises health industry participants with regard to medical devices, drugs and biologics, as well as cosmetics and food products regulated by the U.S. Food and Drug Administration (FDA). He also advises providers, including academic medical centers and hospital systems, on Medicare and Medicaid reimbursement issues. His practice covers regulatory, compliance and policy advice.
Food and Drug Law
Prior to joining the firm, Mr. Brown served in several prominent roles with the FDA. As an FDA detailee, he served as health policy advisor to the Senate Health, Education, Labor and Pensions (HELP) Committee. On behalf of HELP Committee Chairman Tom Harkin (D-IA), Mr. Brown played a lead role in negotiating and drafting the Drug Quality and Security Act of 2013 (drug compounding and track and trace legislation), and in coordinating passage of the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) reauthorizations. He advised committee leadership on a broad range of FDA-related legislative and oversight matters, including device, drug and biologics issues, and met with stakeholders across the FDA-regulated industries.
Before going to the Senate, Mr. Brown served in two roles at the FDA. As special assistant to the chief counsel, he counseled FDA leadership on high-priority and cross-cutting matters, including emerging public health issues, high-profile enforcement cases and congressional investigations. During his time in the Office of the Chief Counsel, he advised the FDA’s Center for Devices and Radiological Health on a wide range of matters, including device review program reform, guidance development, software and health IT regulation, third-party review, laboratory-developed tests and administrative appeals. He served as counsel on the medical device user fee reauthorization (MDUFA III) negotiation team, and represented the FDA in providing assistance to Congress on device reform and MDUFA III provisions of the FDA Safety and Innovation Act of 2012 (FDASIA).
Mr. Brown also served as senior counselor to the associate commissioner for regulatory affairs (ACRA) in the FDA’s Office of Regulatory Affairs (ORA), where he advised the ACRA on compliance, enforcement and policy matters. He represented the ACRA in meetings with industry and in discussions with foreign governments regarding comparability and trade agreements. He also supervised priority matters for the ORA, including implementation of FDASIA supply chain and enforcement provisions, coordination with the Office of the Chief Counsel on enforcement matters and litigation, organization of ORA efforts around import policy and implementation of the Food Safety and Modernization Act, and advising the ACRA on enforcement cases and appeals decisions.
Health Care Law
Mr. Brown has provided regulatory, legislative and litigation counsel to academic medical centers and other hospitals and health care providers in a wide range of issues relating to Medicaid, Medicare and other health programs. He has represented clients before the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) Departmental Appeals Board and various state agencies, and in litigation in federal and state courts.
Mr. Brown was lead counsel in a successful federal law suit on behalf of the American Hospital Association (AHA), the Association of American Medical Colleges (AAMC) and America’s Essential Hospitals (formerly the National Association of Public Hospitals and Health Systems (NAPH)), challenging CMS payment rules (Alameda County Medical Center, et al. v. Michael O. Leavitt, et al., U.S. District Court for the District of Columbia, Case 1:08-cv-00422).
His work has also included representing clients on issues relating to disproportion share hospitals (DSH), graduate medical education (GME), Medicaid upper payment limits (UPL), supplemental payment programs, Children's Health Insurance Program (CHIP), State Plan Amendments, and coverage expansion and drug reimbursement. He has also advised nonprofit and academic hospitals on governance and restructuring matters.
- member, Montgomery County Board of Social Services (2008-2013)
- co-chair, Maryland Health Benefit Exchange Advisory Committee on Financial Sustainability (2011-2012)
- steering Committee Member, Maryland Women’s Coalition for Health Reform (2006-2011)
- staff Member, Gov. O’Malley’s Transition Work Group/Maryland Department of Health and Mental Hygiene (2006-2007)
- In 2001, Mr. Brown served for six months at Bread for the City Legal Clinic, where he handled a variety of Social Security disability appeal cases, family law matters, and landlord and tenant cases.
- speaker, “New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA and 21st Century Cures,” FDLI hosted webinar, February 9, 2018
- speaker, “Key Developments for Medical Device Inspections in the United States and Around the Globe: Are You Prepared?,” MDMA hosted webinar, January 24, 2018
- session co-chair and speaker, “Digital Health Combination Products: What’s Next?,” and “21st Century Cures Act and Beyond – Implications for Digital Health,” DIA Combination Products Conference, North Bethesda, MD October 26, 2017
- session chair, “Appropriate GMPs for Combination Products,” DIA Combination Products Conference, North Bethesda, MD, October 25, 2017
- co-chair, PLI’s Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, New York, October 5, 2017
- moderator, “Coming Changes to Device Inspections: Are You Ready?,” The MedTech Conference 2017, San Jose, CA, September 26, 2017
- panelist, “Digital Health Strategy and Regulation,” MedTech Innovator webinar, August 10, 2017
- panelist, “Medical Software Post-21st Century Cures: Fostering Innovation and Confusion,” at the AdvaMed Innovation Summit in Washington, D.C., April 12, 2017
- speaker, “Regulating at the Speed of Innovation – FDA Pre-Check for Software Development,” at The Digital MedTech Conference in San Francisco, CA, March 2, 2017
- speaker “Update on Recent FDA & Legislative Actions on Digital Health,” at The Digital MedTech Conference’s Start-up Sessions, March 1, 2017
- speaker, “Top International Trade Issues for Medical Devices,” Industry Webinar, November 2016
- co-chair, PLI’s Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries Conference, November 2, 2016
- session chair, FDA Oncology Center of Excellence: Implications for Intercenter Coordination, DIA Combination Products: Current, Evolving, and Future Pathways Conference, October 24, 2016
- speaker, “The Coming Convergence: Digital Health Reaching Its Promise,” AdvaMed 2016 MedTech Conference, October 17, 2016
- panelist, “Innovative Medical Devices and the New Frontier of FDA & FCC Oversight,” AdvaMed Innovation Summit: Diving Into the Ever-Changing Health Care Landscape and the New Digital Frontier, March 30, 2016
- panelist, “Emerging Issues: CyberSecurity, Digital Health,” MDMA 2016 FDA Forum, March 17, 2016
- panelist, “Preemption Issues,” Drug Quality and Security in 2016 Conference, The Food and Drug Law Institute, February 23, 2016
- speaker, “Could State Regulations Be the Next Wave of Preemption Jurisprudence? Drug Compounding as a Case Study,” FDLI Food and Drug Law Journal Symposium: Constitutional Challenges to FDA Law & Regulation, October 30, 2015
- speaker, “FDA Collaboration,” MedTech 2015, October 15, 2015
- speaker, “Integrating Wearable Technology into Medical Devices: Promise or Pipedream?” AdvaMed 2015 MedTech Conference, October 5, 2015
- speaker, “Cybersecurity: Risks and Best Practices for Medical Device Makers,” MDMA Executive Forum, September 25, 2015
- panelist, “Emerging Issues: Cybersecurity, Mobile Health & More,” MDMA Webcast, March 11, 2015
- speaker, “An Early Snapshot of the 114th Congress—Expectations for Health and Life Science Issues,” MedTech Association, February 12, 2015
- speaker, “Legislative Update on Major Policy Provisions and Funding Impacting FDA,” Southeast Wisconsin Biotech Networking Event, February 10, 2015
- speaker, “The Price of Reform: Models for Financing a Toxic Substance Control Act 2.0 Policy,” Roundtable Discussion hosted by Akin Gump, Washington, D.C., February 5, 2015
- speaker, “FDA Regulation of Medical Device Software and Mobile Apps: Recent Developments and What to Expect in 2015,” hosted by PLI, January 20, 2015
- speaker, “Regulatory Guidance for Connected Health Products,” MedTech’s Connected Care Exchange Conference, November 4, 2014
- speaker, “FDA Regulation: Hot Topics,” PLI Webcast, Health Care and Life Sciences Law, October 24, 2014
- panelist, “FDA Regulation of Mobile Medical Apps,” AdvaMed 2014 – The MedTech Conference, October 7, 2014
- speaker, “Looking Ahead: A Forum on 503B Compounding,” Akin Gump Webinar, October 1, 2014
- speaker, “What Hospitals Need to Know about the New Compounding Law,” American Health Lawyers Association Webcast, July 29, 2014.