Califf hearing moves process forward; status of appropriations and reconciliation
Top-Line:
Califf nomination hearing moves process forward.
Legislative status: appropriations and reconciliation.
More on Alliance webinars: two transcripts: Dr. Wilson Bryan on FDA’s plans in the cell and gene therapy area; and Dr. Susan Mayne on FDA’s plans in the nutrition area.
House and Senate announce 2022 Schedules.
More Alliance Webinars planned for 2022. We are open to suggestions.
Analysis and Commentary - This year’s FDA webinars with links, opportunities with Alliance speakers, and excerpts from Dr. Mayne’s webinar.
Califf Nomination Hearing Moves Process Forward. Based on media coverage, Dr. Califf’s confirmation hearing on December 14 went well. Reportedly, Senators Murray and Burr (Chair and Ranking Member on the HELP Committee) are working to schedule a committee vote quickly, then move Dr. Califf’s nomination to the Senate calendar so a vote can be scheduled. However, as with all Senate business, what moves and how fast depends on many factors and tends to be negotiated among Senators themselves. In general, Dr. Califf’s nomination is unlikely to reach the Senate floor this year and, and a January vote is more likely.
In response to inquiries, the Alliance stated that: “FDA needs a Senate-confirmed Commissioner, who can make long-term commitments on behalf the agency. With the hearing now completed, we urge a speedy vote in the HELP Committee and on the Senate floor.”
The Alliance added: “We are pleased that Dr. Califf reaffirmed his commitment to the funding and personnel that FDA needs to fulfill its mission and responsibilities. We are grateful to Chair Murray and Ranking Member Burr and other committee members who also expressed support for increased FDA resources.”
Legislative Status: Appropriations and Reconciliation. The Alliance is primarily focused on the fate of FDA’s FY 22 appropriations, where appropriators slated at least a $200 million increase in the agency’s budget authority (BA) funding. Because the current Continuing Resolution (CR) extends through February 18, we do not expect any movement on appropriations bills until at least mid-to-late January.
The Build Back Better (BBB) reconciliation bill is also pending but unlikely to receive a Senate vote this year. The Alliance is interested in Section 31023 of the House-passed BBB bill, which includes $300 million in no-year money for infrastructure improvements for the FDA. Half of this funding would go to technology and data modernization and the other half to facilities and physical improvements. The draft Senate HELP Committee bill includes this FDA provision as well (Sec. 28023).
More on Alliance Webinars: Two New Transcripts. Here is a link to the transcript for the webinar with Dr. Wilson Bryan on FDA’s plans in the cell and gene therapy area. Here is a similar link for Dr. Susan Mayne’s webinar on FDA’s plans in the nutrition area.
House and Senate Announce 2022 Schedules. The House calendar is linked here. The Senate calendar is linked here. The House is currently in recess and will return on January 10, 2022. The Senate is currently in session. Regardless of when they go into recess, they will return on January 3, 2022.
More Alliance Webinars Planned for 2022. We Are Open to Suggestions. In 2021, the Alliance sponsored a series of nine webinars with senior FDA officials. A list of the events is in this week’s Analysis and Commentary (below), along with links to transcripts and other materials from each. We plan to do more webinars in 2022 featuring Center Directors and other senior leaders of the agency. If you have suggestions for 2022, please send them to Elisa Bayoumi, who will compile them for review by Alliance leadership.
Next Friday Update Will Be January 7, 2022. We will not publish Friday Update during the last two weeks of December. Our next Update will be January 7, 2022. If anything significant occurs during that period, we will put out a special edition. Also, while we will not publish, the Alliance will be staffed during the holiday period and remains available for member and media inquiries.