President Biden nominated Dr. Robert Califf as FDA Commissioner to replace acting Commissioner Dr. Janet Woodcock.

Dr. Califf previously served as the FDA Commissioner from 2016-2017 when he was confirmed with strong bipartisan support with an 89-4 vote. Analysts and FDA officials who worked with Califf during this time at the FDA are confident that he will prioritize Biden’s agenda, most notably increasing access by bringing more generics and biosimilars to the market and removing supply chain barriers. To read the full statement, click here.

CMS announced the largest Part B premium increase in 15 years.

In addition to typical cost growths, the increase is also due, in large part, to the potential costs of Aduhelm. Premiums will increase from $148.50 to $170.10 for next year, but CMS officials say that the 5.9% 2022 Social Security adjustment will cover the increase. CMS Administrator Brooks-LaSure and Rep. Pallone have both pointed to this premium increase as more reason for Congress to do more to reduce drug costs. To read more, click here.

CBO announced they will score the reconciliation package by the end of week (November 19).

They have begun to release cost estimates for some portions of the Build Back Better Act (H.R. 5376), but have not finished all of the Titles, including the drug pricing provisions. The initial White House estimates expect the drug pricing agreement to save approximately $100 billion, plus an additional $150 billion from repealing the rebate rule. The cost estimates for the entire spending bill are expected by end of day on November 19. All related cost estimates can be found here.

CIDSA Experts in the News

Rena Conti, Richard Frank, and their colleague wrote a perspective piece in the New England Journal of Medicine on how to regulate drug prices while increasing innovation. The authors propose a three-part strategy to increase savings for patients and payers and encourage more high-value innovation. The strategy requires the drug-pricing environment to reward true value, expand NIH funding for early-stage research and development, and to reduce risks that innovator companies take on with later-stage development. To read the full paper, click here.

• As the lead author, Rena Conti was also interviewed by the journal. To hear more about the paper, listen here.

Sean Dickson and a colleague analyzed the association of generic competition with price decreases in physician-administered drugs and the estimated price decreases for biosimilar competition in a JAMA article. The study found that adopting a bundled biosimilar reimbursement model would have reduced biologic prices by 48% in 2021 which would have generated more savings and increased incentives for biosimilar market entry. To read the full article, click here.

• Ameet Sarpatwari and his colleague wrote an invited commentary piece on Dickson’s JAMA piece.  To read the full article, click here.

Rachel Sachs spoke with reporters at Bloomberg Government on the possible impact of the spending bill. Sachs is quoted saying that “the idea that drugmakers get a government-backed monopoly for a period of time to recoup their investment in new drugs and then must face competition has long been the ‘social bargain’ of the US pharmaceutical approval system.” Sachs maintains that negotiation will work to ensure that the price will go down after the nine or thirteen years of exclusivity, as it is intended to. To read the full article, click here.

Rachel Sachs spoke with reports at Endpoints News on the potential for the drug pricing agreement to reduce the need for pay-for-delay or citizen petition reforms. To read the full article, click here.