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OMB's Newly Proposed Acquisition Pilot Program Could Be a Game-Changer

Client Alert | 1 min read | 06.13.19

In late April, the Office of Management and Budget (OMB) sent a letter to Congress, which contained a number of legislative proposals to streamline and improve the agility and efficiency of the federal acquisition process, one of which would establish an “Acquisition Modernization Test Board.” According to the letter, this Board would authorize the Administrator of the Office of Federal Procurement Policy (OFPP) “to exercise a waiver of one or more acquisition or procurement laws as part of a pilot program to evaluate how changing the statutory requirement(s) might facilitate more efficient achievement of the purpose underlying the law.” Importantly, this proposal would give OFPP enormous discretion and flexibility to pilot innovative and new approaches to streamlining and deregulating acquisitions. OMB seeks enactment of this and other proposals as part of Title 8 (the acquisition title) of the Fiscal Year 2020 National Defense Authorization Act, and, assuming that Congress approves this expanded authority for OFPP (either as part of an NDAA or otherwise), industry should take this opportunity to recommend innovative acquisition pilots. 

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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....