FY 22 Funding Bill negotiations; Dr. Califf’s nomination advances; Alliance statement on need for a Senate-confirmed Commissioner.
Top-Line:
Analysis and Commentary - the FY 23 appropriations cycle and uncertainties about timing.
Discussions continue on FY 22 Omnibus Funding Bill before the current CR expires.
Dr. Califf’s nomination advances.
Alliance stresses need for a Senate-confirmed Commissioner.
Upcoming Alliance Webinars. The first two webinars for 2022 have been scheduled:
Acting FDA Chief Scientist Dr. Jacqueline O’Shaughnessy on Tuesday, January 25, 2022, at 1 p.m.
"How FDA Is Funded" featuring Alliance Board Member Emily Holubowich and Executive Director Steven Grossman on Wednesday, February 2, 2022, at 3 p.m.
Why sign up to hear the Acting FDA Chief Scientist.
Why sign up to learn “How FDA is Funded.”
This week’s Analysis and Commentary (below) discusses what we know about the FY 23 appropriations cycle and the uncertainties about the timing of key activities.
Discussions Continue on FY 22 Omnibus Funding Bill Before Current CR Expires. The House and Senate Appropriations Committees have until February 18 to produce an FY 22 Omnibus Appropriations Bill or face the need for a further extension of the CR. Given drafting and floor time, it means an agreement would have to be reached by February 11, four weeks from today. The good news is that the chairs and ranking members on both Senate and House Appropriations Committees are talking. The unwelcome news is that the parties appear to still be far apart on total spending, the balance between defense and non-defense spending, new policy riders, and the restoration of previous policy riders.
Based on the current House and Senate positions on FY 22 funding for FDA, the agency could see at least $200 million more if appropriations bills are adopted and no increase if there were to be a full-year CR. FDA is not alone in needing the higher funding levels likely to be in appropriations bills and certain to be absent from a CR. Interestingly, the Defense Department and its stakeholders face the same dilemma. The House Appropriations Committee heard testimony this week on DOD funding problems created by a CR. An article on the hearing is here.
Dr. Califf’s Nomination Advances. On Thursday, January 13, the Senate Health, Education, and Labor Committee voted 13-8 with one not present to advance Dr. Califf’s nomination to be Commissioner of the Food and Drug Administration. The affirmative votes included 9 Democrats and 4 Republicans. The negative votes included 2 Democrats and 6 Republicans. Senator Rand Paul chose not to vote. The four Republicans who voted for Dr. Califf were Senators Burr, Collins, Murkowski, and Romney. The two Democrats who opposed were Senators Sanders and Hassan. At this point, we do not know when a floor vote will be scheduled.
The Alliance Stresses Need for a Senate-Confirmed Commissioner. Reflecting the organization’s broad membership and our focus on the agency’s resource needs, the Alliance does not back specific candidates for FDA Commissioner. However, we have consistently voiced support for speedy nomination and confirmation of a new Commissioner when a vacancy exists. While the agency has been blessed—this time and in the past—with effective interim leadership, the issue is an institutional one. No matter how effective an Acting Commissioner might be, they cannot make the long-term commitments that are essential for the FDA’s effectiveness.
Accordingly, on January 12, the Alliance issued the following statement in response to media inquiries:
"FDA’s leadership has never been more essential than today, as we face the challenges posed by COVID-19 as well as constantly accelerating developments in science, technology, innovation, and societal needs.
FDA needs a Senate-confirmed leader during these difficult and rapidly changing times. Accordingly, the Alliance for a Stronger FDA urges the Senate to act speedily to confirm a new FDA Commissioner."
Upcoming Alliance Webinars. The first two webinars for 2022 have been scheduled:
Acting FDA Chief Scientist Dr. Jacqueline O’Shaughnessy on Tuesday, January 25, 2022, at 1 p.m. To join us, please sign up here.
“How FDA Is Funded” featuring Alliance Board Member Emily Holubowich and Executive Director Steven Grossman on Wednesday, February 2, 2022, at 3 p.m. To join us, please sign up here.
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
Why Sign Up to Hear the Acting FDA Chief Scientist? The Office of the Chief Scientist is a hub for scientific programs that support the Centers, as well as the overall FDA mission. The Chief Scientist oversees the National Center for Toxicological Research and initiatives involving advancing regulatory science, technology transfer, scientific professional development, and scientific integrity. The Office also oversees the FDA’s Medical Countermeasures Initiative (MCMi). It is in the latter capacity that the FDA Chief Scientist has become a central figure in the EUAs that have been issued in response to the COVID-19 pandemic.
Why Sign Up to Learn “How FDA is Funded.” FDA funding is complicated—more so than many other federal agencies. FDA benefits from multiple funding sources, but this also creates confusion about which sources of money support which activities. Our webinar will review the five distinct types of FDA funding and explain the implications, particularly in a year when both the appropriations process and renewal of user fee agreements will be before Congress at the same time.