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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
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs point to yes” that everything on the list below will continue to be major areas of focus for both FDA and the U.S. Congress next year and into the foreseeable future.
Viewpoint
On December 10-11, 2018, FDA hosted a public workshop, Medical Device Servicing and Remanufacturing Activities, as part of its effort to develop a draft guidance that will distinguish servicing activities from remanufacturing. FDA expressed intent to develop a draft guidance on this topic as part of its May 15, 2018 report to Congress on the quality, safety, and effectiveness of medical device servicing. This post provides some observations about areas of agreement among stakeholders and FDA’s perspective on servicing versus remanufacturing.
Viewpoint
The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety and effectiveness. SaMD is software used for a medical purpose that is not part of a hardware medical device. The new approach is known familiarly as Pre-Cert and relies on a company being certified by FDA as having a culture of quality and organizational excellence.
Viewpoint
Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar spent on products ranging from heart valves to insulin to breakfast cereal, so there’s always something Congress can do in the realm of FDA’s statutory authorities. Many FDA-related bills are often bipartisan, too, which suggests action regardless of which party is in power. Here are a few key medical product issues we’ll be tracking in 2019.
Viewpoint
On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety. The 510(k) program relies on a device being compared to a legally marketed predicate device; i.e., a similar device that was already determined to be legally marketable.
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 feature article discusses the industry’s reaction to the Food & Drug Administration’s (FDA) newly-released information on their medical software precertification program. The article notes that initial reactions are split regarding an important question – If the FDA has statutory authority to implement pre-certification. 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 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.
Aaron Josephson, ML Strategies Senior Director who previously worked for the Food & Drug Administration (FDA), discusses the FDA's proposed rule on the de novo pathway. Aaron notes that this could provide necessary clarity for device manufacturers, modernize the 510(k) premarket notification process and help the FDA achieve the performance goals laid out by Congress.
ML Strategies Senior Director Aaron Josephson, a former FDA senior policy advisor, is quoted in this feature story that looks at claims made that the FDA's Medical Device Enforcement and Quality Report was released in an effort to silence criticism that the FDA does not take sufficient enforcement action when appropriate.
In an effort to modernize and tighten its medical device clearance process, the Food & Drug Administration (FDA) announced plans to publish the names of devices cleared using predicate devices that are 10 years and older. ML Strategies Senior Director Aaron Josephson, a former FDA Senior Policy Advisor, is among the industry sources quoted in the article providing commentary.
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 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