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Contractor's Report to OIG Insufficient to Trigger Public Disclosure Bar

Client Alert | less than 1 min read | 03.27.14

In U.S. ex rel Saunders v. Unisys Corp. (E.D. Va.), the court found that the relator's FCA claim was not precluded by the public disclosure bar despite the defendant providing its internal investigation report to OIG because (1) the report failed to reveal allegations or transactions creating an inference of fraud (its conclusion that the alleged fraudulent billing practices were "unacceptable" was not enough) and (2) it was made available only to the DOD IG and the government agency overseeing the contract and not the general public.


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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....