Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more
This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Earlier today, the US Court of Appeals for the Third Circuit issued a much-anticipated decision in one of the 340B contract pharmacy cases. The decision is a win for drug manufacturers who have sought to restrict access to...more
This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more
As explained in prior postings, there are three forums that have jurisdiction or authority to hear bid protests: the procuring agency, the U.S. Accountability (GAO), and the U.S. Court Federal Claims (COFC). Here we will...more
The Contract Disputes Act establishes the formal process for resolving nearly all claims and disputes that arise under federal government contracts. It is the source of the requirement that contractors certify claims in...more
The ACCC 47th Annual Meeting & Cancer Center Business Summit (AMCCBS) took place virtually, March 1-5. The Cancer Center Business Summit was co-founded in 2007 by Foley & Lardner LLP and CCBD Group as an opportunity for...more
Historically, bid protests were filed in the federal district courts. Under the Administrative Procedures Act, 5 U.S.C. § 702, federal district courts reviewed challenges to agency procurement decisions. Known as the...more
On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing...more
On December 10, 2020, the Health Resources and Services Administration (HRSA) released a Final Rule to establish an administrative dispute resolution (ADR) process and ADR panels to resolve certain 340B Program disputes...more
The U.S. Department of Justice (DOJ) recently prevailed in its challenge of Novelis’ proposed merger with Aleris Corporation. The challenge involved a first-of-its kind use of arbitration under the Administrative Dispute...more
DOJ Antitrust Division successfully uses private-style arbitration for first time to block a merger, and force a divestiture as a condition to closing.1 DOJ’s novel use of arbitration to resolve liability in a merger case has...more