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Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries

Author(s): Nathan A. Brown, Scott D. Danzis
Practice Area: Health Care
Published: Nov 2016
ISBN: 9781402427794
PLI Item #: 150167
CHB Spine #: M10

Nathan A. Brown is a partner in the health care and life sciences practice who focuses on food and drug law, particularly as it relates to medical devices, drugs and biologics.

Practice & Background

Nathan A. 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). His practice covers regulatory, compliance and policy advice.

Prior to joining the firm, Mr. Brow n served in several prominent roles with the FDA. Most recently, he was detailed by the FDA to serve as health policy advisor to the Senate Health, Education, Labor and Pensions (HELP) Committee to cover FDA issues. On behalf of HELP Committee Chairman Tom Harkin (D-IA), Mr. Brow n played a lead role negotiating and drafting the Drug Quality and Security Act of 2013 (drug compounding and track and trace legislation), and 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 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 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 FDA in providing assistance to Congress on device reform and MDUFA III provisions of the FDA Safety and Innovation Act of 2012 (FDASIA).

While at FDA, Mr. Brown also served as senior counselor to the associate commissioner for regulatory affairs (ACRA) in the Office of Regulatory Affairs (ORA), w here 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 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.

Prior to his work at FDA, Mr. Brown was a lawyer in private practice, w here he focused on providing regulatory, legislative and litigation counsel to national associations, public and non-profit hospitals and other health care providers in a wide range of issues relating to Medicaid, Medicare and other health programs. He represented clients before the Centers for Medicare & Medicaid Services, the Department of Health and Human Services Departmental Appeals Board, various state agencies and in litigation in federal and state courts. He also advised clients on election law and lobbying law requirements. 

Public Service

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)

Community Involvement

In 2001, Mr. Brow n served for six months at Bread for the City Legal Clinic, w here he handled a variety of Social Security disability appeal cases, family law matters and landlord and tenant cases.

Speaking Engagements

“What Hospitals Need to Know about the New Compounding Law ,” July 29, 2014.

Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.

From 2006 to 2008, Mr. Danzis served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration. While at FDA, he was broadly involved in a wide range of legal and regulatory matters related to medical devices and drugs. He also worked on implementing key provisions of the Food and Drug Administration Amendments Act of 2007.