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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 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)

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

News & Press

Events

Viewpoints

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Next Steps for 21st Century Cures 2.0

May 8, 2020 | Blog | By Aaron Josephson

On Monday, April 27, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) announced the next steps for 21st Century Cures 2.0 (Cures 2.0), legislation that will build on the original 21st Century Cures Act enacted in December 2016 (Cures 1.0). While Cures 1.0 aimed to speed up the process of bringing new treatments to market, Cures 2.0 is generally envisioned to emphasize public health and streamlined care delivery, particularly in light of the COVID-19 pandemic. Elements envisioned to be in Cures 2.0 were outlined in a recently published concept paper that we discuss in this post.
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Rough Seas for COVID-19 Serology Tests Lead to Course Correction by FDA

May 5, 2020 | Blog | By Joanne Hawana, Hope Foster, Aaron Josephson

Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020 the Food and Drug Administration (FDA) announced a revised policy aimed at reducing the risks associated with such tests.
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CARES Act Creates and Updates Drug and Medical Device Shortage Requirements

April 9, 2020 | Blog | By Elizabeth Conti, Aaron Josephson

In response to the COVID-19 pandemic, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law on March 25, 2020. In addition to the $2 trillion made available for medical countermeasure development, business relief, and other measures, the CARES Act amends the drug shortage reporting requirements and creates new requirements related to medical device shortages. With increased demand for products used to diagnose and treat COVID-19 patients and the stress placed on the manufacturing and delivery of vital products, having more information about drug, drug ingredient, and device shortages is becoming more critical.
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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

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).  The agencies warned the companies that their health claims lacked credible supporting evidence and emphasized the FDA does not recognize a vaccine, drug, or treatment for the disease.  
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FDA’s Ongoing Response to the COVID-19 (Coronavirus) Outbreak

March 18, 2020 | Blog | By Joanne Hawana, Aaron Josephson, Benjamin Zegarelli

As we write this update on the actions of the Food and Drug Administration (FDA), more state and local governments (along with private businesses and employers) are taking sweeping actions to protect the public from the continued spread of COVID-19. The federal response to what is now a pandemic of COVID-19 started off slowly, but we are now seeing frequent and promising announcements from FDA and other agencies within the Department of Health and Human Services.

We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.
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Federal Response to COVID-19

March 16, 2020 | Alert | By Alexander Hecht, Frank C. Guinta, Christian Tamotsu Fjeld, Aaron Josephson, R. Neal Martin, Anthony DeMaio

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.
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Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act in both chambers of Congress. The bipartisan legislation closely tracks existing medical device laws, with some notable exceptions, discussed below and in a prior post. If enacted, many regulatory elements familiar to in vitro diagnostic (IVD) and other medical device manufacturers would be applied to clinical laboratories that develop their own tests, commonly known as laboratory developed tests (LDTs). The bill also includes elements that are priorities for the Food and Drug Administration (FDA), including a program conceptually similar to pre-certification, third-party review, and Collaborative Communities. Unlike previously-circulated discussion drafts, the introduced bills include specific language designed to address public health emergencies, including COVID-19.
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FDA’s Evolving Response to the COVID-19 (Coronavirus) Outbreak

March 4, 2020 | Blog | By Aaron Josephson, Joanne Hawana

Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at the forefront of the COVID-19 (coronavirus) outbreak as the government seeks to control and prevent the spread of the virus in the United States. The National Institutes of Health (NIH), particularly the National Institute of Allergy and Infectious Diseases, are also involved, primarily conducting research into the sources, cause, and means of transmission of the new virus and coordinating vaccine development efforts. The Food and Drug Administration (FDA) is responsible for assuring the safety and effectiveness of medical products and therefore has oversight over any clinical trials for promising coronavirus treatments (drugs, vaccines, devices), as well as authority to authorize the marketing of any such product. The agency oversees the drug supply chain and monitors drug and device shortages. This blog post covers steps that FDA has taken to mitigate potential drug and device shortages related to coronavirus and to otherwise respond to the coronavirus situation.
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Collaborative Communities

February 27, 2020 | Video | By Aaron Josephson

ML Strategies’ 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.
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Closing the Orphan Drug Act Loophole

February 18, 2020 | Blog | By Aaron Josephson

On Tuesday, February 11, 2020, Senators Bill Cassidy (R-LA), Jeanne Shaheen (D-NH), and Tammy Baldwin (D-WI) introduced legislation to eliminate the “orphan drug loophole.” Current law allows the Food and Drug Administration (FDA) to grant seven years of market exclusivity to a drug manufacturer if the drug is intended to treat a disease or condition affecting fewer than 200,000 patients in the U.S., or less commonly, if the manufacturer cannot expect to recover the costs of developing and marketing a drug. In some cases, even if the drug developer meets the orphan drug criterion of having no hope of recovering the costs, the drug does actually become profitable—some significantly so—but competitors are still barred from entering the market with a lower-cost alternative during the 7-year exclusivity period that exists by operation of law. To combat this issue, the recently introduced Senate bill (as well as a nearly-identical House bill introduced in October 2019) targets a loophole that allows market exclusivity under the Orphan Drug Act to be extended for future versions of the same drug without the drug's manufacturer having to show that the drug remains unprofitable.
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News & Press

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A recent 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.
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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.
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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.
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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.
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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.
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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.”
Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests. The groups have different views on FDA’s purview, but they generally agree that diagnostic tests should be regulated differently than traditional medical devices. ML Strategies Senior Director Aaron Josephson talks about this latest draft of the bill.
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.
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

Apr
14
2020

FDA in the Time of COVID-19

View the Webinar Recording

Panelist
Sep
24
2019

Six-Month Assessment: The Impact of Gottlieb’s Departure on FDA Priorities

Mintz, 3580 Carmel Mountain Road | Suite 300, San Diego, CA

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

Speaker
Apr
16
2019

American Telemedicine 2019 Annual Conference and Expo

FDA's New Approach to Digital Health

Arlington, VA

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