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Monday, May 4, 2026

Policy and Medicine March 2022 Issue Features FDA Exclusivity, Baby Powder, and FCA Case Dismissal - Policy & Medicine

Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth in issues and stay up to date on the latest trends. We encourage you to subscribe to our monthly publication Policy and Medicine Compliance Update.

March 2022 issue focus is on the financials. We begin by analyzing the DOJ’s FY 2022 False Claim Act (“FCA”) Statistics. Although the money recovered declined when compared to FY 2021, that only tells part of the story.

Next, we shift gears to explore the latest developments with J&J’s baby powder. Recently the Third Circuit rejected J&J’s attempt to place its litigation liability in a single entity and put it into bankruptcy (the so-called Texas Two-Step). Although the case involves consumer products, it has significant implications for pharmaceutical companies attempting to contain their product liability exposure.

We also explore Sandoz’s attempts to overturn an FDA decision granting new chemical entity (“NCE”) exclusivity. According to the complaint, Sandoz estimated that FDA’s decision would cost the company well over $100 million.

In our final article, we return to the FCA. In this article, we explore the government’s recent opposition to attempts to dismiss a whistleblower’s lawsuit utilizing the public disclosure bar. The case is unusual because the government is typically pushing for dismissal.

FALSE CLAIM ACT STATISTICS FOR FISCAL YEAR 2022

SIGNIFICANT RECOVERIES FROM A LARGER...



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