Aaron is based in our Washington, DC office and is a Senior Director of ML Strategies. He advises clients on health care policy issues with a focus on medical devices, pharmaceuticals, and vaccines.
Aaron helps companies understand and participate in federal and state policymaking activities. His experience includes creating coalitions of people and organizations who are aligned on how best to solve a policy challenge, helping people and organizations develop policy positions, and advocating for changes to statutes, regulations, standards, and other policy directives (such as guidance documents). He has written parts of the Federal Food, Drug, and Cosmetic Act (the law giving FDA authority to regulate food, drugs, vaccines, devices, etc.) and he has successfully crafted, negotiated, advocated for, and implemented policies and programs relating to FDA user fees, digital health and software regulation, new oversight models for clinical lab tests (including LDTs), medical device servicing (also known as Right to Repair), continuous manufacturing, and drug competition and access, among other subjects.
Aaron's successes include:
- Securing federal funding for a client developing novel therapeutic manufacturing technologies
- Securing FDA authorization and funding for a client developing a low-cost, portable ventilator
- Preventing the issuance of a CDC policy that would have distorted the market for certain medical devices
- Creating a coalition of medical device manufacturers to advocate for changes related to improving the safety of serviced and remanufactured devices
- Developing a strategic action plan and a fundraising plan for a nonprofit focused on improving vaccine education
- Helping COVID-19 therapeutic, vaccine, and device developers understand FDA regulations and other requirements related to obtaining emergency use authorization, approval, clearance, and licensure; and, assisting those companies in accessing federal funding to support medical countermeasure development
Prior to joining ML Strategies, Aaron spent more than 10 years with the U.S. Food and Drug Administration, most recently as a senior policy advisor in the Center for Devices and Radiological Health (CDRH) where he led legislative policy development activities related to all aspects of medical device regulation and oversight. He was a key conduit between FDA and the Department of Health and Human Services (HHS), other federal agencies and departments, and Congress, a role in which he educated those organizations about FDA policies and programs. He also advised multiple FDA Commissioners and other senior officials on strategy and content for meetings with industry representatives, patient advocates, and Congress, including preparing two FDA Commissioners for their Senate confirmation hearings. In addition to negotiating the reauthorization of the medical device user fee program (MDUFA), Aaron led FDA’s interactions with Congress during the development of the 21st Century Cures Act and the FDA Reauthorization Act; he oversaw the implementation of those laws following their enactment.
Earlier, Aaron was a budget analyst in the FDA’s Center for Drug Evaluation and Research (CDER), where he developed the agency’s annual budget for drug regulation and oversight and justified it to Members of Congress. He began his FDA career in the Center for Biologics Evaluation and Research (CBER) where he performed analyses of scientific and regulatory data and prepared reports for Congress about FDA's policies, programs, and user fee performance.
During his tenure with the FDA, Aaron won numerous agency awards, including the Lireka P. Joseph Award for Excellence in Public Health Communication. He also received special recognition from multiple FDA Commissioners, including a June 2017 special citation for outstanding and sustained performance in the negotiation and reauthorization of MDUFA IV and an August 2016 award for contributions to the 21st Century Cures Act.
Aaron’s prior work experience includes analyzing laws and regulations applicable to small businesses and the automotive industry. He was also an intern for the Member of Congress representing his home district in Maryland.
Aaron earned a master’s certificate in project management from the George Washington University School of Business and is certified by the American Society for Quality as a quality improvement associate.
- Johns Hopkins University (MS)
- University of Virginia (BA)
Recognition & Awards
- Lireka P. Joseph Award for Excellence in Public Health Communication (2018)
- Commissioner’s Special Citation for Outstanding and Sustained Performance in the Successful Negotiation and Reauthorization of MDUFA IV (2017)
- CDRH Director’s Citation for Managing MDUFA IV Negotiation (2016)
- Commissioner’s Citation for contributions to the 21st Century Cures Act (2016)
- CDRH Director’s Award for excellence in managing high-priority legislation (2015)
- FDA Technical Excellence Award for developing a solution to track adjuvants in vaccine products (2013)
News & Press
January 8, 2021| Blog
November 23, 2020| Blog
October 19, 2020| Blog
March 24, 2020| Blog
March 16, 2020| Alert
February 27, 2020| Video
February 14, 2020| Video
News & Press
November 25, 2020 | Medtech Insight
November 23, 2020 | Inside Health Policy
November 9, 2020 | POLITICO
November 5, 2020 | Inside Health Policy
April 20, 2020 | Inside Health Policy
April 1, 2020 | Law360
February 6, 2020 | Boston Business Journal
October 23, 2019 | Inside Health Policy
September 26, 2019 | MedTechDive
August 20, 2019 | Inside Health Policy
July 25, 2019 | Inside Health Policy
June 12, 2019 | MedCityNews
In the article, Mr. Josephson remarks that, “establishing a new regulatory paradigm for complex medical technologies is no easy task.” The pilot program has already raised a number of concerns among smaller companies, including the high cost and value related to the number of products developed. Despite the preliminary issues and uncertainty from Congress, Mr. Josephson maintains that, “the FDA should be applauded for taking proactive steps to create a regulatory climate that balances innovation and safety.”