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
Webinar Recording: FDA in 2021: A Look Ahead
February 18, 2021 |Webinar
Looking Ahead: FDA in 2021
January 8, 2021 |Blog
FDA in 2020: What a Year!
December 15, 2020 |Blog
News & Press
Senior Director of ML Strategies Aaron Josephson was quoted in Inside Health Policy on the Biden administration’s plans to reverse several Trump administration regulatory-focused executive orders, including two last-minute executive orders from the Trump administration on accountability in agency rulemaking and criminal penalties for violating certain agency regulations.
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.
Events
The U.S. Food and Drug Administration (FDA) had an extraordinarily busy 2020, and things do not appear to be slowing down anytime soon. Join Mintz attorney Joanne Hawana and Aaron Josephson and Anthony DeMaio from ML Strategies for a fireside discussion to explore policy activities that will likely have the greatest impact on stakeholders in 2021, and how the new Administration may impact the FDA in the year ahead and beyond.
Join Mintz and ML Strategies for a webinar on a spectrum of legal issues companies in the life sciences industry are facing during this complicated period.
Viewpoints
Webinar Recording: FDA in 2021: A Look Ahead
February 18, 2021 | Webinar | By Joanne Hawana, Aaron Josephson, Anthony DeMaio
In this fireside discussion, Mintz attorney Joanne Hawana and Aaron Josephson and Anthony DeMaio from ML Strategies explored policy activities that will likely have the greatest impact on stakeholders in 2021, and how the new Administration may impact the FDA in the year ahead and beyond.
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Looking Ahead: FDA in 2021
January 8, 2021 | Blog | By Aaron Josephson
Politics will have an effect on FDA policies in 2021, including with respect to the ongoing COVID-19 response, manufacturing, compliance, digital health, laboratories, user fees, device servicing, and more.
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FDA in 2020: What a Year!
December 15, 2020 | Blog | By Aaron Josephson, Benjamin Zegarelli
What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.
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Post-Election 2020 - Health Care Preview
November 23, 2020 | Blog | By Alexander Hecht, Anthony DeMaio, Aaron Josephson, Brett Else, Tara E. Dwyer, Ellyn Sternfield
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.
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FDA Provides Update on Pre-Cert Program and Launches Digital Health Center of Excellence
October 19, 2020 | Blog | By Aaron Josephson
You’d be forgiven in the current climate of coronavirus and election season, to name just a couple hot issues of the day, for missing two recent announcements from the FDA about its digital health program. On September 14, 2020, FDA published “Developing the Software Precertification Program: Summary of Learnings and Ongoing Activities” and the following week, on September 22, launched the Digital Health Center of Excellence.
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Beyond COVID: House Committee Advances Several FDA-Related Bills
July 23, 2020 | Blog | By Aaron Josephson, Margaret Jewett
Despite the COVID-19 pandemic, the House Energy & Commerce Committee continues work on several health policy issues, including Orphan Drug Act reform and continuous manufacturing.
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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.
Read more
News & Press
Biden Admin Begins Massive Review, Reversal Of Trump Admin Regs, EOs
January 21, 2021
Senior Director of ML Strategies Aaron Josephson was quoted in Inside Health Policy on the Biden administration’s plans to reverse several Trump administration regulatory-focused executive orders, including two last-minute executive orders from the Trump administration on accountability in agency rulemaking and criminal penalties for violating certain agency regulations.
Experts: HHS Review Proposal May Free Industry From Regulatory Red Tape
November 25, 2020
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
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
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
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.
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.
What FDA Has Done So Far In Response To COVID-19
April 1, 2020
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
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.
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 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.
FDA Commissioner Sharpless Says Hiring Reform, New Tech, and Real-World Evidence Are Top Priorities
July 25, 2019
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
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.”
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.
Experts Disagree Over Whether FDA Has Authority For Pre-Cert
January 10, 2019
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 Clarifies Breakthrough Device Pathway, Safer Tech Program
December 18, 2018
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.
Device Expert: FDA De Novo Rule Provides Clarity For Industry
December 5, 2018
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.
Medical Device Expert: FDA Report Responds To Enforcement Criticism
November 29, 2018
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.
FDA’s Move To Publish Names Of Devices With Old Predicates As Part Of 510K Reform Shocks Industry
November 27, 2018
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.
FDA Floats Humane Dog Drug Study, Hopes Industry Will Follow Suit
November 20, 2018
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.
Drug Lawyers: FDA’s Complete Response Letters Are Anything But
November 8, 2018
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
Speaker
Speaker
Apr
7
2020
Everything Life Sciences Companies Need to Know to Navigate the COVID-19 Pandemic
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
Speaker
Apr
16
2019
American Telemedicine 2019 Annual Conference and Expo
FDA's New Approach to Digital Health
Arlington, VA
Speaker
Panelist
Nov
1
2018