Potential for a long endgame on appropriations; A government shutdown is highly unlikely, but not unimaginable.
Top-Line:
Full House/Senate Committee have Finished Ag/FDA Appropriations, with the potential for a long endgame.
A government shutdown is highly unlikely, but not unimaginable.
Saying thanks to Congress is important.
Upcoming Alliance Webinar - FDA Chief Scientist Denise Hinton and NCTR Director William Slikker (October 15, 3:00-4:00 PM ET)
We Answer Alliance Member’s Questions.
Full House/Senate Committee Have Finished Ag/FDA Appropriations; Potentially Long Endgame. This September, the FDA’s FY 22 appropriations situation is further advanced and more favorable than in most years. However, there is only a small possibility of a quick resolution. Otherwise, the agency will start the new fiscal year funded by a Continuing Resolution (CR) starting October 1. It is impossible to handicap when Congress will resolve the macro-budgetary issues that have the effect of holding up FDA funding. Last week’s Analysis and Commentary recaps the funding cycle thus far and describes the issues that need to be resolved.
Government Shutdown: Highly Unlikely, But Not Unimaginable. Operating under a Continuing Resolution is difficult for FDA and other federal agencies that have expanding responsibilities. When faced with level funding and limitations on new initiatives, FDA must make hard choices every day, knowing that some important activities will be underperformed or undone. However, as we learned in December 2018 and the following weeks, the worst funding scenario for FDA is a government shutdown. Earlier articles in Friday Update have termed the threat of a shutdown this year as “unimaginable”. Unfortunately, we must revise that assessment to “highly unlikely but not unimaginable”.
As we reach September 10, just 3 weeks before the new fiscal year starts on October 1, there are several potential political chokepoints. There is no clear path forward on infrastructure legislation, reconciliation, or on a bipartisan agreement on total FY 22 spending levels. Compounding that is a looming need to raise the federal debt ceiling—made more dire by Treasury Secretary Yellen’s announcement this week that funds are likely to run out in October rather than November. Senate Minority Leader McConnell has said that raising the debt ceiling should be added to the Democratic reconciliation bill where Republican votes won’t be needed. House Speaker Pelosi has made clear that a debt ceiling increase will not be in the reconciliation bill. While a shutdown is still highly unlikely, the worsening political climate on Capitol Hill leads us to be less certain than our prior assessment.
Saying Thanks to Congress Is Important. It is important to convey our thanks to the House and Senate Appropriations Committees for their support and actions to date on FY 22 FDA funding. As described above and in last week’s Analysis and Commentary, both the full House and Senate Appropriations Committee have been highly supportive of the FDA’s growing responsibilities and the resources the agency needs to fulfill its mission in FY 22. We also want to acknowledge that appropriators’ willingness to invest in FDA’s data capacity, technology, and physical plant. For key points to include in letters of thanks, see this week’s Analysis and Commentary.
This Week’s Analysis and Commentary: We Answer Alliance Member’s Questions. This week’s Analysis and Commentary is devoted to questions that Alliance members have asked up about the details and interpretation of the House and Senate Appropriations Committee’s funding levels for FDA for FY 22, as well as some points to include in letters of thanks to appropriators.
Upcoming Alliance Webinars. We continue to invite FDA leadership to address the Alliance membership and media. Just recently we scheduled FDA Chief Scientist Denise Hinton and NCTR Director William Slikker (October 15, 3:00-4:00 PM ET). The Office of the Chief Scientist at FDA is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. Working closely with the FDA’s product centers, the Office provides strategic leadership and support for FDA’s regulatory science and innovation initiatives, including the Advancing Regulatory Science Initiative, FDA's Technology Transfer Program, scientific professional development, scientific integrity, and the Medical Countermeasures Initiative (MCMi). The National Center for Toxicology Research (NCTR) conducts scientific research to generate data for FDA decisionmaking and develops and supports innovative tools and approaches that FDA uses to protect and promote individual and public health.
We have several more programs in development. Beyond those, we are interested in hearing from Alliance members: who would you like to hear from among FDA’s senior leadership? If you have someone in mind, please let Alliance Executive Director Steven Grossman know at: sgrossman@strengthenfda.org.