Drawing upon Nathan A. Brown diverse health care industry and governmental experience, Nathan Brown provides his clients with strategic, practical advice on cutting-edge regulatory, compliance and policy matters. He has worked extensively in the FDA regulatory field and also on coverage and reimbursement matters. His varied knowledge allows him to make connections across disciplines and take a multifaceted, creative approach to advising clients.Innovative health care technology and delivery systems are rapidly transforming the sector, giving rise to new payment, regulatory and enforcement approaches.
Nathan helps sophisticated clients prepare for these developments and, when necessary, influence them. He is sought after for his understanding and insights into the regulation of and payment for innovative approaches to health care, such as medical software, advanced diagnostics and pharmaceutical supply chain solutions. Nathan speaks and writes frequently about FDA policy developments and regulatory issues surrounding digital health and other topics.
Nathan works with clients in a broad range of highly regulated areas and issues, including:
- Medical devices and diagnostics
- Medical software and digital health
- Pharmaceuticals
- Hospitals, health systems and healthcare networks
- Medicaid, Medicare and health care access
- Medical products supply chain.
Experience:
- Served in prominent roles at the Food and Drug Administration (FDA) and on the Senate Health, Education, Labor and Pensions (HELP) Committee.
- Advises manufacturers and developers of medical devices and diagnostics, drugs and biologics, and other industry participants regulated by the FDA, as well as hospitals and other providers.
- Focuses on food and drug law and health care reimbursement and regulatory issues.
Representative Work:
- Represented a leading medical technology trade association in user fee negotiations with the FDA and in developing policy reforms for medical devices in the 21st Century Cures Act of 2016 and the FDA Reauthorization Act of 2017.
- Advised a premier academic medical center in relation to the first de novo clearance obtained by a provider for a next-generation sequencing (NGS) oncology test.
- For multiple companies, assisted in obtaining favorable regulatory treatment of novel software-based interventions, including de novo clearances and developing marketing and compliance strategies to support product commercialization.
- Assisted a client in developing a comprehensive global compliance policy relating to product quality and manufacturing, advertising and marketing, price reporting and supply chain considerations.
- Represented outsourcing facilities in regulatory and compliance issues relating to implementation of the Drug Quality and Security Act of 2013, which, while working for the Senate HELP Committee, helped negotiate and draft.
Affiliations:
- Member, Food and Drug Law Journal Editorial Advisory Board, 2018 – present.
Education:
- J.D., Harvard Law School, 1999
- B.S., University of Maryland, College Park, 1996
- B.A., University of Maryland, College Park, 1995
Bar Admissions:
- District of Columbia
Cost
Rate : $$$
