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)
Recent Insights
Viewpoints
Looking Ahead: FDA in 2021
January 8, 2021|Blog
Post-Election 2020 - Health Care Preview
November 23, 2020|Blog
FDA Provides Update on Pre-Cert Program and Launches Digital Health Center of Excellence
October 19, 2020|Blog
News & Press
In an article published by Medtech Insight, Senior Director of ML Strategies Aaron Josephson provided commentary on a recent proposal from the U.S. Department of Health and Human Services (HHS) to review regulations every 10 years and its potential impact on the medical device industry.
In an article published by Inside Health Policy, Mintz Member Joanne Hawana and Senior Director of ML Strategies Aaron Josephson commented on calls from industry leaders for the Biden administration to consider making the U.S. Food and Drug Administration (FDA) an independent agency, separate from the U.S. Department of Health and Human Services (HHS), which they assert would be unlikely to move very far in Congress.
Senior Director of ML Strategies Aaron Josephson was quoted in POLITICO on the U.S. Department of Health and Human Services’ proposed rule that would require its agencies, including the U.S. Food and Drug Administration, to review all regulations within two years and determine if any can be cut.
Viewpoints
Looking Ahead: FDA in 2021
January 8, 2021| Blog
The U.S. Food and Drug Administration had a busy 2020, as detailed in earlier blog posts. This blog post explores politics and a few policy activities we’ll be keeping an eye on in 2021 and how they might impact medical product manufacturers, particularly now that we know the U.S. Senate will be controlled, like the U.S. House of Representatives and the White House, by Democrats.
Post-Election 2020 - Health Care Preview
November 23, 2020| Blog
With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy.
FDA Provides Update on Pre-Cert Program and Launches Digital Health Center of Excellence
October 19, 2020| Blog
Next Steps for 21st Century Cures 2.0
May 7, 2020| Blog
Rough Seas for COVID-19 Serology Tests Lead to Course Correction by FDA
May 5, 2020| Blog
CARES Act Creates and Updates Drug and Medical Device Shortage Requirements
April 9, 2020| Blog
Tackling False Claims Being Made for COVID-19 Treatments and Products
March 24, 2020| Blog
Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to treat Coronavirus Disease 2019 (COVID-19).
Federal Response to COVID-19
March 16, 2020| Alert
Read about the federal government’s response to COVID-19, including $8B in emergency funding and the Families First Coronavirus Response Act pending in the House.
Collaborative Communities
February 27, 2020| Video
Aaron Josephson explains why FDA is looking to Collaborative Communities to help solve challenges in 2020 and the potential benefit to companies who participate in the development of public policy.
FDA User Fee Agreements
February 14, 2020| Video
In this video, Aaron Josephson discusses FDA user fee agreements, the timeline for the reauthorization process, and why it is important for companies with FDA-regulated products to be paying attention now.
News & Press
Experts: HHS Review Proposal May Free Industry From Regulatory Red Tape
November 25, 2020 | Medtech Insight
In an article published by Medtech Insight, Senior Director of ML Strategies Aaron Josephson provided commentary on a recent proposal from the U.S. Department of Health and Human Services (HHS) to review regulations every 10 years and its potential impact on the medical device industry.
McClellan: Biden Admin Should Make FDA An Independent Agency
November 23, 2020 | Inside Health Policy
In an article published by Inside Health Policy, Mintz Member Joanne Hawana and Senior Director of ML Strategies Aaron Josephson commented on calls from industry leaders for the Biden administration to consider making the U.S. Food and Drug Administration (FDA) an independent agency, separate from the U.S. Department of Health and Human Services (HHS), which they assert would be unlikely to move very far in Congress.
Pharmaceutical Industry Wins in Divided Election
November 9, 2020 | POLITICO
Senior Director of ML Strategies Aaron Josephson was quoted in POLITICO on the U.S. Department of Health and Human Services’ proposed rule that would require its agencies, including the U.S. Food and Drug Administration, to review all regulations within two years and determine if any can be cut.
User Fees Will Be A Focus For Senate HELP, No Matter Who’s In Charge
November 5, 2020 | Inside Health Policy
An article published by Inside Health Policy featured extensive commentary from Senior Director of ML Strategies Aaron Josephson on priorities for the Senate Health, Education, Labor and Pensions (HELP) Committee following the 2020 Presidential election. Mintz Member Joanne Hawana was also quoted in the article.
Hahn Signals COVID-19 Could Affect User Fee Goals, Device Talks Put Off
April 20, 2020 | Inside Health Policy
An article published by Inside Health Policy quoted remarks made by Senior Director of ML Strategies Aaron Josephson during a recent Mintz and ML Strategies webinar focused on the U.S. Food and Drug Administration (FDA)’s response to the COVID-19 pandemic.
What FDA Has Done So Far In Response To COVID-19
April 1, 2020 | Law360
Mintz Member Joanne Hawana, Senior Director of ML Strategies Aaron Josephson, and Mintz Associate Benjamin Zegarelli co-authored an article published in Law360 discussing the latest actions from the U.S. Food and Drug Administration (FDA) in response to COVID-19.
Op-Ed: A 2020 Call To Action On Medical Devices
February 6, 2020 | Boston Business Journal
Senior Director of ML Strategies Aaron L. Josephson authored an op-ed published by the Boston Business Journal about opportunities to shape medical device public policy in 2020, including user fees, user fee riders, and Collaborative Communities.
Warren, Cassidy To FDA: How Will You Identify Device Remanufacturers?
October 23, 2019 | Inside Health Policy
An article published by Inside Health Policy quoted Aaron Josephson, Senior Director at ML Strategies, on Senators Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) letter to U.S. Food and Drug Administration (FDA), requesting information about the FDA's upcoming guidance clarifying the distinction between remanufacturers and servicers.
To Pitch Pre-Cert to Congress, FDA Builds a Case First
September 26, 2019 | MedTechDive
MedTechDive reported that the U.S. Food and Drug Administration is not yet ready to go to Congress to seek new powers for its evolving precertification pilot for software, but it will need new authorities to determine how the experimental path fits into the current regulatory scheme. The article included commentary from Senior Director of ML Strategies Aaron Josephson and Mintz Associate Benjamin Zegarelli.
Former FDAer Defends FDA Decision to Withdraw Data Falsification Rule
August 20, 2019 | Inside Health Policy
An article published by Inside Health Policy quoted Aaron Josephson, Senior Director at ML Strategies, extensively in response to recent debate surrounding the U.S. Food and Drug Administration’s proposed rule “Reporting Information Regarding Falsification of Data,” which was previously withdrawn.
FDA Commissioner Sharpless Says Hiring Reform, New Tech, and Real-World Evidence Are Top Priorities
July 25, 2019 | Inside Health Policy
Acting U.S. Food and Drug Administration Commissioner Ned Sharpless told agency staff in an email on July 23 that his top priorities are to develop frameworks for regulating new technologies; invest in the agency's workforce; help to lower drug prices by encouraging drug competition; and improve postmarket surveillance of regulated products. In an article published by Inside Health Policy, ML Strategies Senior Director Aaron Josephson commented extensively on Sharpless’ priority list.
Senior Director of ML Strategies Authors Article Published by MedCityNews on FDA’s Pre-Cert Program
June 12, 2019 | MedCityNews
On June 12, MedCityNews published an article authored by Senior Director of ML Strategies Aaron Josephson addressing challenges faced by the U.S. Food and Drug Administration (FDA)’s Pre-Certification (“Pre-Cert”) program. The Pre-Cert program would revolutionize regulation and oversight of certain medical devices.
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.”
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.”
Regulatory Experts: OMB Memo Could Drastically Slow FDA Guidances
April 15, 2019 | InsideHealthPolicy.com
ML Strategies Senior Director Aaron Josephson is featured in this article, which discusses a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress – that could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.
FDA Accepts Feedback On VALID, Clinical Lab Test Lobby Encouraged
March 28, 2019 | Inside Healthy Policy
This article explores American Clinical Laboratory Association (ACLA) president and CEO Julie Khani’s desire to start a dialogue with FDA to refine aspects of a draft bill that would redefine the agency’s regulatory authority over diagnostics. Specifically, she hopes to work with the agency on revisions to the bill's provision involving precertification and modification of existing tests in order to make those concepts less burdensome for test makers. Aaron Josephson, a senior director at ML Strategies and former senior policy advisor at FDA’s device center, is among the industry sources quoted within the piece.
Device Experts: Pre-Cert, 510(k) Reforms Unaffected By Gottlieb Departure
March 9, 2019 | Inside Health Policy
FDA Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are quoted in this article discussing how the FDA’s big-ticket medical device reform initiatives, such as medical software precertification, 510(k) predicate reform and changes to the de novo process likely will continue to develop as planned even as FDA Commissioner Scott Gottlieb, who has drawn attention to such efforts throughout his two-year tenure as agency chief, is due to resign in one month.
Former FDA Advisor: Abernethy Could Be Next In Line To Lead FDA
March 7, 2019 | Inside Health Policy
FDA Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are quoted in this article discussing the possibility of FDA Principal Deputy Commissioner Amy Abernethy filling in as acting FDA commissioner, or possibly even succeed FDA Commissioner Scott Gottlieb when the current commissioner leaves the agency in a month.
FDA Clarifies Breakthrough Device Pathway, Safer Tech Program
December 18, 2018 | Inside Health Policy
FDA Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are featured in this article discussing two recently-announced actions by the Food & Drug Administration (FDA) to encourage industry adoption of two accelerated review and development pathways for new devices. The FDA’s announcement centered upon a final guidance on the breakthrough devices pathway and recommendations for a new Safer Technologies Program (STeP).
'Reined-In' US Diagnostics Legislation Adds Pre-Certification, Other Updates
December 12, 2018 | Medtech Insight
This feature story looks at a new revised bill focused on the Food & Drug Administration’s (FDA) regulation of diagnostics. The piece notes that the bill, currently being reviewed by members of Congress, would provide a great number of updates including the ability for FDA to leverage a pre-certification process to validate test developers. ML Strategies Senior Director Aaron Josephson is among the industry sources providing commentary in the piece.
FDA Floats Humane Dog Drug Study, Hopes Industry Will Follow Suit
November 20, 2018 | Inside Health Policy
ML Strategies Senior Director Aaron Josephson is among the industry sources providing commentary in this article on the FDA's proposal to test a minimally invasive dog drug study.
Device Experts: Expanded Special 510(k) Good For Software, Review Times
October 2, 2018 | Inside Health Policy
This feature article notes the medical device industry’s reaction to a draft guidance released by FDA aimed at expanding the use of a faster premarket review program could, if finalized, be particularly useful for software companies. The piece further notes that this could help the FDA achieve its goal of reducing its average 510(k) review times. FDA Practice Chair Bethany Hills and ML Strategies Senior Director Aaron Josephson are among the industry sources providing commentary.
Events
Speaker
Sep
30
2020
Speaker
Dec
4
2019
FDA Update – In Conjunction with ASQ – New England Biomedical Discussion Group & RAPS
MassMEDIC
860 Winter St, Waltham, MA 02451
Panelist
May
21
2019
The Digital Core in Pharma and Personalized Medicine Development
Mintz 3580 Carmel Mountain Road | Suite 300 San Diego, CA 92130
Panelist
May
3
2019
Food and Drug Law Institute Annual Conference
Current Proposals for Diagnostics Reform
Washington, DC
Speaker
Apr
24
2019
Speaker