Dr. Califf Sworn in as FDA Commissioner. FY 22 Appropriations – agreement reached on topline numbers, other details being negotiated.
Top-Line:
Analysis and Commentary - The Challenges of the Confirmation Process.
Dr. Califf Sworn in as FDA Commissioner.
FY 22 Appropriations - CR Through March 11 Approved.
FY 22 Appropriations – agreement reached on topline numbers, other details being negotiated.
FY 23 Appropriations.
Webinars completed, webinar series on FDA’s FY 23 budget priorities announced:
This week’s Analysis and Commentary is devoted to congratulating Dr. Califf and reviewing the challenges of the confirmation process.
Dr. Califf Sworn in as FDA Commissioner. Dr. Robert Califf has been sworn in to once again serve as the Commissioner of the Food and Drug Administration. He was confirmed by the Senate with a 50-46 vote that can be found here. The Alliance congratulates him on his confirmation and will work to schedule a meeting with him. FDA’s announcement regarding his swearing-in can be found here. HHS Secretary Xavier Becerra released a statement welcoming Dr. Robert M. Califf back to FDA that can be read here.
FY 22 Appropriations: CR Through March 11 Approved. The Senate by a vote of 65-27 approved a CR extending government funding until March 11. The focus now turns to the FY 22 Omnibus Appropriations bill.
FY 22 Appropriations: Agreement Reached on Topline – Other Details Being Negotiated. We previously reported that House and Senate Appropriations leadership reached agreement on a framework for finishing the FY 22 appropriations process. Senate Committee Chairman Leahy has said that the agreement will provide the biggest increase in non-defense programs in four years with new resources to improve health care in rural communities, expand the middle class, and protect national security. Subcommittee staffs are reportedly now working out the details of each appropriations measure.
Legislative Status: FY 23 Appropriations. We continue to hear that the President’s FY 23 Budget Request could be released during the week of March 7 or March 14, following his State of the Union address on March 1.
FDA Meeting March 14 to Review Hiring and Retention Final Assessment Report. The Food and Drug Administration has announced it will hold a virtual meeting entitled ``FDA Hiring and Retention Final Assessment'' on March 15, 2022. There is also an opportunity to submit public comments by May 16, 2002. According to the Federal Register notice, the topic to be discussed is the FDA Hiring and Retention Final Assessment, which was an independent assessment performed by Booz Allen Hamilton, published on December 10, 2021.
The public meeting is intended to provide an update on FDA's progress towards the Perscription Drug User Fee Act (PEDUFA VI) and the Biosimilar User Fee Amendments Act of 2017 (BsUFA II) hiring and retention commitments and solicit input on actions regarding the hiring process. These evaluation assessment reports can be found here.
The Federal Register notice containing information about how to register for the meeting and how to submit public comments can be found here.
Alliance Announces Webinar Series on FDA’s FY 23 Budget Priories. Starting April 4, we will hear from FDA’s Center Directors and the Associate Commissioner for Regulatory Affairs on the agency’s budget priorities, as follows:
Patrizia Cavazzoni, MD | CDER | April 4, 1 p.m. | Register
Judith McMeekin | ORA | April 6, 2 p.m. | Register
Susan Mayne, PhD | CFSAN | April 12, 11 a.m. | Register
Steven Solomon, DVM | CVM | April 22, 3 p.m. | Register
Jeff Shuren, MD | CDRH | April 29, 11 a.m. | Register
We expect to announce a CBER date shortly.
These online events are for Alliance members and media, although we welcome guests. If you are not a member and would like to participate, please contact Alliance Executive Director Steven Grossman