Committee Chairman Pallone (D-NJ) and oversight subcommittee Chairwoman DeGette (D-CO) requested Eli Lilly, Novo Nordisk, and Sanofi to come forward with details on the work they have done to make insulin more accessible to patients. In the letter, the Representatives remind the three manufacturers of their previous interactions in January 2019, where they all agreed that high insulin prices are a shared concern. To read the Committee’s press release, click here.
The board will “facilitate and coordinate all supply chain initiatives across CDER and provide strategic guidance on major supply chain issues,” according to the CDER press release. The governance board in CDER’s response to the White House report ordered by the executive order which included recommendations to create “secure, robust, and resilient supply chains.” The board will begin reviewing pharmaceutical supply chain issues in September 2021. To read the full announcement, click here.
Generic drug groups, such as the Association for Accessible Medicines, have advocated for rebate and biosimilar policies to be included in the report, due August 23. The group’s recommendations include rebate walls, reduced cost-sharing for generic drugs, and a shared savings demonstration. The shared savings program would allow prescribing physicians to share the savings generated by the difference in ASP of biologics and the biosimilar they prescribe. Both the generic and brand drug industry are against policies such as common billing codes for Part B biosimilars and reference products, which is said to be in consideration as one of the recommendations included in the report. To read the full article, click here.
The California Attorney General announced a $75 million nationwide settlement with Bristol Myers Squibb over allegation of unpaid drug rebates. Of the settlement, the federal government was given $41,360,523 and the states involved were granted the remaining $33,639,477. To read the full press release, click here.
Stacie Dusetzina coauthored a Health Affairs blog post on the accelerated approval pathway’s impact on value-based pricing. Dusetzina and her colleague discussed recommendations to improve the accelerated approval pathway, including how coverage and reimbursement for products approved through this process should work. To read the full blog post, click here.
Ameet Sarpatwari spoke with reporters at Bloomberg Law on the impact that the COVID booster shot will have on global production. Sarpatwari was quoted saying that “with limited production and the knowledge that we are encouraging boosters for everyone now, it risks compounding the inequity we are already seeing.” To read the full article, click here.