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Aaron L. Josephson

Senior Director

[email protected]

+1.202.434.7454

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Aaron is based in our Washington, DC office and is a Senior Director of ML Strategies. He advises clients on health care policy issues related to medical devices and pharmaceuticals. 

Prior to joining ML Strategies, Aaron spent 10 years with the US Food and Drug Administration, most recently as a senior policy advisor in the Center for Devices and Radiological Health 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, and other stakeholders. In addition to negotiating the reauthorization of the medical device user fee program (MDUFA), Aaron led FDA’s implementation of key provisions of the 21st Century Cures Act and the FDA Reauthorization Act.

Earlier, Aaron was a budget analyst in the FDA’s Center for Drug Evaluation and Research, where he developed the center’s annual budget and provided information to the Congressional Budget Office (CBO) and congressional authorizers. He began his FDA career in the Center for Biologics Evaluation and Research as an information management specialist responsible for data analyses to support FDA policies and programs.

During his tenure with the FDA, Aaron won numerous agency awards, including the Lireka P. Joseph Award for Excellence in Public Health Communication or Education. 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 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
On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be churning out over the next year. The list includes nearly 200 rules, 23 of which are already posted on the Office of Information and Regulatory Affairs (OIRA) dashboard. The bulk of the rules on the Agency Rule List for Fall are under the purview of CMS or the FDA (63 and 77 rules, respectively). Also, earlier in October, FDA’s device center released a list of draft and final guidance documents it plans to publish in FY 2019. Many of these rules or guidance documents touch on issues top of mind and we expect that the administration will be moving forward with many of these priorities in the coming months. 
Viewpoint
Artificial intelligence—AI—is the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of patients or their health care providers? This post, the second in our blog series about AI in health care, explores FDA’s proposed regulatory model that is supposed to be better suited for AI (and similar technologies) while still protecting patients.

News & Press

This article notes that drug industry lawyers are encouraging the Food & Drug Administration (FDA) to provide specific feedback during new product reviews to drug applicants. The objection to the current process is that it does not address crucial details and makes the process more frustrating and contentious than it should be. Aaron Josephson, Senior Director of ML Strategies who spent 10 years at FDA, is among the industry sources quoted in the article. 
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

Panelist
Nov
1
2018

2018 Technology in Psychiatry Summit: Closing Gaps in Translation

De-Risking Digital Development: Unpacking the Innovation Pipeline in Substance Use Disorder Treatment

Boston, MA