About me

Address: Washington, D.C.: Robert S. Strauss Tower, 2001 K Street, N.W., Washington, DC 20006-1037

Areas of Focus: Food & Drug Law; Regulatory; Royalty Monetization; Sovereign & Government Investors; National Security

Biography:
Drawing upon his diverse health care industry and governmental experience, Nathan 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. Nathan also represents clients on due diligence and regulatory issues related to corporate transactions. 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 health care networks
- Medicaid, Medicare and health care access
- Medical products supply chain.

Representative Work:
- 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 he, while working for the Senate HELP Committee, helped negotiate and draft.
- 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.

Credentials:
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, 2000

Recognitions:
- Chambers USA, Healthcare: Pharmaceutical/Medical Products Regulatory, 2019-2026.
- The Legal 500 US , Healthcare: Life Sciences, 2024-2025, "Leading Partner," 2025-2026.

Affiliations:
- Associate Chief Counsel, FDA, 2010-2012
- Senior Counsel, Office of the Associate Commissioner for Regulatory Affairs, FDA, 2012-2013
- Counsel, Senate Committee on Health, Education, Labor and Pensions, 2013-2014
- Member, Food and Drug Law Journal Editorial Advisory Board, 2018-2025

Insights:
- New GRAS Notification is on the Menu in FDA Proposed Rule (Ultra-Processed Foods on the Side) (August 13, 2026): https://www.akingump.com/en/insights/alerts/new-gras-notification-is-on-the-menu-in-fda-proposed-rule-ultra-processed-foods-on-the-side
- FDA Seeks Feedback on Proposed Quantitative Medicine Innovation Network (August 11, 2026): https://www.akingump.com/en/insights/blogs/eye-on-fda/fda-seeks-feedback-on-proposed-quantitative-medicine-innovation-network
- Congress Takes Action on FDA Bills Ahead of August Recess (August 7, 2026): https://www.akingump.com/en/insights/alerts/congress-takes-action-on-fda-bills-ahead-of-august-recess
- Akin Advises Pharmakon Advisors on Debt Financing for ARCHIMED’s Up to $1.1 Billion Acquisition of Esperion Therapeutics (July 22, 2026): https://www.akingump.com/en/insights/press-releases/akin-advises-pharmakon-advisors-on-debt-financing-for-archimeds-up-to-dollar11-billion-acquisition-of-esperion-therapeutics
- CMS Rolls Out New ‘Make Hospital Food Healthier’ Pledge  (July 16, 2026): https://www.akingump.com/en/insights/alerts/cms-rolls-out-new-make-hospital-food-healthier-pledge
- Akin Advises Pharmakon Advisors in $200 Million Term Loan Facility for Kestra Medical Technologies (July 15, 2026): https://www.akingump.com/en/insights/press-releases/akin-advises-pharmakon-advisors-in-dollar200-million-term-loan-facility-for-kestra-medical-technologies
- FDA Explores Expediting Clinical Trials: Announces Ambitious New Drug Pilot Program (June 29, 2026): https://www.akingump.com/en/insights/blogs/eye-on-fda/fda-explores-expediting-clinical-trials-announces-ambitious-new-drug-pilot-program
- Akin Advises Pharmakon Advisors on CHF 250 Million Term Loan to Idorsia Ltd (June 26, 2026): https://www.akingump.com/en/insights/press-releases/akin-advises-pharmakon-advisors-on-chf-250-million-term-loan-to-idorsia-ltd
- Akin Advises Pharmakon Advisors in $500 Million Senior Secured Term Loan to Mineralys Therapeutics (June 11, 2026): https://www.akingump.com/en/insights/press-releases/akin-advises-pharmakon-advisors-in-dollar500-million-senior-secured-term-loan-to-mineralys-therapeutics
- Akin Secures Top Rankings in The Legal 500 US 2026  (June 10, 2026): https://www.akingump.com/en/insights/awards-and-accolades/akin-secures-top-rankings-in-the-legal-500-us-2026
- FDA Issues Draft Guidance on Payor Communications to Address Statutory Changes (June 10, 2026): https://www.akingump.com/en/insights/blogs/eye-on-fda/fda-issues-draft-guidance-on-payor-communications-to-address-statutory-changes
- Chambers USA 2026 Recognizes Akin Lawyers and Practices  (June 4, 2026): https://www.akingump.com/en/insights/awards-and-accolades/chambers-usa-2026-recognizes-akin-lawyers-and-practices