The nine drug manufacturers with products selected for Medicare drug price negotiations have agreed to participate in the program. Seven of them now have pending suits challenging the Inflation Reduction Act program with Novo’s recent complaint, which objects to the aggregation of its insulin products.

Drug manufacturers will have to participate in the Medicare drug price negotiation process for the foreseeable future. Judge Newman's finding that participation in Medicare is voluntary could defeat constitutional challenges to the program and have an impact on other cases. 

Drug manufacturers will have to participate in the Medicare drug price negotiation process for the foreseeable future. Judge Newman's finding that participation in Medicare is voluntary could defeat constitutional challenges to the program and have an impact on other cases. 

Chamber files petition to have FTC amend its disqualification rules to have commissioners explain their rejection of recusal requests. FTC is seeking public comments on the petition.

BIO objects to guidelines seeking to block mergers that would eliminate a potential entrant in a concentrated market and give greater scrutiny to transactions that are part of a series of company deals. APhA and NCPA call for FTC to consider more factors in PBM mergers.

FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.