This post continues our ongoing coverage of the FY 2024 NDAA. 

The FY 2024 NDAA includes numerous supply chain and stockpile management provisions aimed at addressing a host of perceived vulnerabilities and weaknesses in Department of Defense (“DoD”) supply chain networks used to secure goods and services for our national defense.  Of particular note, this year’s NDAA seeks to address China’s and Russia’s continued dominance in the global supply chain for many critical materials and rare earth elements.  Supply chain- and stockpile-related measures in the NDAA could present significant opportunities for contractors poised to support the U.S. Government’s efforts to on-shore and friend-shore U.S. and DoD sourcing and manufacturing, but Congress’s focus on increasing supply chain visibility could also herald new rounds of compliance and reporting requirements attached to federal procurements.Continue Reading Key Supply Chain Provisions of the National Defense Authorization Act (“NDAA”) for Fiscal Year (“FY”) 2024

Last week, the White House Office of Science and Technology Policy (“OSTP”) issued a request for information (“RFI”) to learn how the Government can more effectively “support scientific discovery, the development of technological advances, and increase the impact of a vibrant bioeconomy on the Nation’s vitality and our citizens’ lives.” 84 Fed. Reg. 47561 (Sep. 10, 2019). The Bioeconomy is the “infrastructure, innovation, products, technology, and data derived from biologically-related processes and science that drive economic growth, promote health, and increase public benefit.” Id. To establish guiding principles to promote and protect the U.S. Bioeconomy, OSTP is seeking input from interested parties, including “those with capital investments, performing innovative research, or developing enabling platforms and applications in the field of biological sciences, to include healthcare, medicine, pharmaceuticals, biotechnology, manufacturing, energy production, and agriculture.” Id. Of particular interest to government contractors, OSTP is seeking information regarding opportunities for public-private partnerships, infrastructure investments, and best practices for data sharing and data protection. Id. at 47562. Responses are due on or before 11:59 pm on October 22, 2019. We have included the specific topics on which OSTP seeks input below.
Continue Reading White House Seeks Input from Biotech Stakeholders on Bioeconomy

On Tuesday, March 13, 2018, Oregon Governor Kate Brown signed into law House Bill 4005 (HB 4005), which imposes substantial new state reporting requirements on pharmaceutical manufacturers regarding drug pricing, including details on manufacturer-sponsored patient assistance programs. HB 4005 also imposes new reporting requirements on health insurers and establishes a temporary task force charged with developing “a strategy to create transparency for drug prices across the entire supply chain of pharmaceutical products.”[1]
Continue Reading Oregon HB 4005: New Reporting Requirements for Drug Manufacturers, Health Insurers

Over the last few weeks, much attention has been paid to California’s recently enacted SB 17, legislation that requires pharmaceutical manufacturers to report certain price increases of prescription drugs and, in some cases, provide a justification for such increases. The legislation also requires health insurers and health plans to report additional rate information to state agencies. California’s push to impose disclosure of prescription drug pricing information is part of a growing trend of proposed and enacted legislation across the country purportedly aimed at increased price transparency and control.
Continue Reading California Law Aims to Scrutinize Drug Pricing

This week, the U.S. Court of Appeals for the First Circuit declined to revive a False Claims Act qui tam suit against Baxter Healthcare Corporation, agreeing with the district court that the relators were not the “first to file.” The case is United States ex rel. Ven-A-Care of the Florida Keys, Inc. v. Baxter Healthcare Corp., Nos. 13-1732, 13-2083 (1st Cir. Dec. 1, 2014).

The first-to-file rule prevents an aspiring FCA relator from filing a suit that is similar or related to an already-pending qui tam suit. It derives from 31 U.S.C. § 3730(b)(5), which provides that “no person other than the Government may intervene or bring a related action based on the facts underlying” a pending qui tam suit. In the First Circuit, the first-to-file rule is jurisdictional, which allowed the appeals court here to dispose of the case on that ground alone and avoid a myriad of tricky issues wrapped up in this procedurally convoluted case. As the court noted, however, it is less clear whether other jurisdictions, like the D.C. Circuit, consider the first-to-file rule to be jurisdictional.

The would-be relators in this case were a former Baxter employee and an employee of a Baxter customer. In a 2005 suit, they alleged that Baxter, a pharmaceutical company, defrauded the Government by artificially padding the prices of its drugs, which triggered inflated reimbursements from Medicare and Medicaid. But a decade earlier, in 1995, a Florida pharmacy had filed a similar qui tam action alleging the same types of claims against multiple pharmaceutical companies, including Baxter. Baxter ultimately settled with the pharmacy, but not until 2011—6 years after the employee-relators filed their case. After extensive procedural skirmishing unrelated to the issue at hand, Baxter asserted that the employee-relators could not maintain their qui tam suit because the Florida pharmacy was the first to file.Continue Reading First Circuit Finds Pharma Relators’ Suit Ten Years Too Late Under First-to-File Rule