Skip to main content

Aaron L. Josephson

Senior Director

ALJosephson@mlstrategies.com

+1.202.434.7454

Follow:
Share:

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 and pharmaceuticals.

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, and other policy directives (such as guidance documents). His portfolio includes work related to FDA’s user fee programs, FDA’s approach to 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 pricing, among other subjects.

Prior to joining ML Strategies, Aaron spent more than 10 years with the US 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 also apprised members of Congress and their staffs about FDA policies and programs and advised multiple FDA Commissioners and other senior officials on strategy and content for meetings with Congress, industry representatives, patient advocates, and other stakeholders. 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 center’s annual budget and provided information to Members of Congress about the agency's regulation and oversight of drugs. He began his FDA career in the Center for Biologics Evaluation and Research (CBER) where he performed analyses of scientific and regulatory data for use in reports to senior agency officials and 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 a 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)

Recent Insights

News & Press

Viewpoints

Viewpoint Thumbnail

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.
Viewpoint Thumbnail

FDA User Fees: How Do They Work?

January 28, 2020| Blog

Viewpoint Thumbnail

2020 Congressional Highlights

January 15, 2020| Advisory

Viewpoint Thumbnail
In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory developed tests (LDTs) and other in vitro diagnostics (IVDs). The proposed approach would create an entirely new category of medical product separate from medical devices known as in vitro clinical tests (IVCTs).
Viewpoint Thumbnail
On March 5, 2019, FDA Commissioner Scott Gottlieb announced his resignation. The physician and venture capitalist, ​for whom this was ​a second stint at the FDA, intends to leave the agency in about a month to spend more time with his family. In this post, Aaron Josephson reflects on Dr. Gottlieb's time leading the FDA and its future after his departure.
Viewpoint Thumbnail
In our first Device Modernization series post, we discussed how FDA is proposing to modernize the 510(k) review program. FDA also recently issued a proposed regulation for the De Novo program and linked that proposed regulation to 510(k) modernization efforts as part of a broader strategy to improve device safety.
In our “FDA 2018 Year in Review (and a Few Thoughts on 2019)” post and recent webinar, we observed that we may look back at 2018 as the beginning of the end for the 510(k) program as it has existed since the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. The 510(k) pathway has been scrutinized for years and among the most damning criticisms leveled against it is that it is a loophole that lets unsafe products on the market by allowing manufacturers to, in most cases, avoid clinical testing.

News & Press

News Thumbnail MLS

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.
News Thumbnail MLS
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.

News Thumbnail MLS
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.
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.
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.
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.”

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.

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.
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.
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).
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.
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.
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
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

16th Annual Medical Device Quality Congress

Servicing & Remanufacturing

Bethesda, MD