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Fourth Circuit Weighs in on Public Disclosure Bar and Retroactivity

Client Alert | 1 min read | 12.13.13

The Fourth Circuit in U.S. ex rel. Radcliffe v. Purdue Pharma.(Dec. 12, 2013) became the first court of appeals to address whether the FCA's public disclosure bar is still jurisdictional after its 2010 amendment by the Affordable Care Act (a topic about which Crowell & Moring attorneys wrote articles in March and September) and held that it is not, reasoning that the word jurisdiction was excised from the statute and that the government was newly empowered to veto application of the bar. This decision came in the context of a broader analysis in which the court clarified that the date of the allegedly fraudulent conduct, not the date that the complaint was filed, governs potential retroactive effect.


Insights

Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....