
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.
Education
- 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)
Viewpoints
Webinar Recording: FDA in 2021: A Look Ahead
February 18, 2021 | Webinar | By Joanne Hawana, Aaron Josephson, Anthony DeMaio
Looking Ahead: FDA in 2021
January 8, 2021 | Blog | By Aaron Josephson
FDA in 2020: What a Year!
December 15, 2020 | Blog | By Aaron Josephson, Benjamin Zegarelli
Post-Election 2020 - Health Care Preview
November 23, 2020 | Blog | By Alexander Hecht, Anthony DeMaio, Aaron Josephson, Brett Else, Tara E. Dwyer, Ellyn Sternfield
FDA Provides Update on Pre-Cert Program and Launches Digital Health Center of Excellence
October 19, 2020 | Blog | By Aaron Josephson
Beyond COVID: House Committee Advances Several FDA-Related Bills
July 23, 2020 | Blog | By Aaron Josephson, Margaret Jewett
Next Steps for 21st Century Cures 2.0
May 8, 2020 | Blog | By Aaron Josephson
Rough Seas for COVID-19 Serology Tests Lead to Course Correction by FDA
May 5, 2020 | Blog | By Joanne Hawana, Hope Foster, Aaron Josephson
CARES Act Creates and Updates Drug and Medical Device Shortage Requirements
April 9, 2020 | Blog | By Elizabeth Conti, Aaron Josephson
Tackling False Claims Being Made for COVID-19 Treatments and Products
March 24, 2020 | Blog | By Christian Tamotsu Fjeld, Joanne Hawana, Karen Lovitch, Joseph Miller, Aaron Josephson
News & Press
Biden Admin Begins Massive Review, Reversal Of Trump Admin Regs, EOs
January 21, 2021
Experts: HHS Review Proposal May Free Industry From Regulatory Red Tape
November 25, 2020
McClellan: Biden Admin Should Make FDA An Independent Agency
November 23, 2020
Pharmaceutical Industry Wins in Divided Election
November 9, 2020
User Fees Will Be A Focus For Senate HELP, No Matter Who’s In Charge
November 5, 2020
What FDA Has Done So Far In Response To COVID-19
April 1, 2020
Op-Ed: A 2020 Call To Action On Medical Devices
February 6, 2020
To Pitch Pre-Cert to Congress, FDA Builds a Case First
September 26, 2019
FDA Commissioner Sharpless Says Hiring Reform, New Tech, and Real-World Evidence Are Top Priorities
July 25, 2019
Senior Director of ML Strategies Authors Article Published by MedCityNews on FDA’s Pre-Cert Program
June 12, 2019
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.”
Experts Disagree Over Whether FDA Has Authority For Pre-Cert
January 10, 2019
FDA Clarifies Breakthrough Device Pathway, Safer Tech Program
December 18, 2018
Device Expert: FDA De Novo Rule Provides Clarity For Industry
December 5, 2018
Medical Device Expert: FDA Report Responds To Enforcement Criticism
November 29, 2018
FDA’s Move To Publish Names Of Devices With Old Predicates As Part Of 510K Reform Shocks Industry
November 27, 2018
FDA Floats Humane Dog Drug Study, Hopes Industry Will Follow Suit
November 20, 2018
Drug Lawyers: FDA’s Complete Response Letters Are Anything But
November 8, 2018
Events
Everything Life Sciences Companies Need to Know to Navigate the COVID-19 Pandemic
View the Webinar Recording
