News & Analysis as of

Enforcement Priorities Life Sciences

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Blank Rome LLP

[Webinar] 180 Days of the Trump Administration—Quick Hits on Executive Orders, Actions, and Policies - July 17th - August 13th,...

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Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more

Latham & Watkins LLP

100 Days In: FDA Updates and Trends to Watch

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Recent developments include leadership changes, workforce reductions, and policy shifts at HHS and FDA, reshaping agency operations under President Trump’s administration....more

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

Fenwick & West LLP

CLE Takeaways: 2025 Life Sciences M&A Trends

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While life sciences M&A activity surges in today’s markets, the shift in regulatory enforcement priorities, constant innovation in technology, and strategic growth opportunities are changing the way dealmakers are approaching...more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Goodwin

DOJ Renews Focus on Private Equity Amid Record False Claims Act Enforcement

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2023 was another record year for False Claims Act enforcement. On February 22, 2024, the U.S. Department of Justice (DOJ) announced that the federal government and whistleblowers were party to a record number of FCA...more

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q1 2023

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Our prior updates covered how FTC enforcement activity largely proceeded “as usual” during 2022 in the life sciences industry, with large pharmaceutical players buying or licensing promising, but still risky, assets from...more

Epstein Becker & Green

DOJ’s FY 2022 False Claims Act Recoveries: A Mixed Bag

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On February 7, 2023, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2022, which ended on September 30, 2022. While total recoveries exceeded $2.2...more

Hogan Lovells

Unapproved stem cell therapies remains a top FDA enforcement priority

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Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Chief Counsel, discussed the investigations priorities for FDA’s Office of the Chief Counsel (OCC), including its focus on stopping...more

Skadden, Arps, Slate, Meagher & Flom LLP

Will FDA and DOJ Reassert Their Enforcement Muscle With Life Sciences in 2022?

Takeaways - Despite predictions that the Biden administration would devote increased enforcement resources to the life sciences industry broadly, so far, the FDA and DOJ have focused their efforts on COVID-related conduct. ...more

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