Battle for Speaker has Implications for Appropriations

Top Line

• Alliance’s First Webinar of 2023; January 13 with Andi Fristedt, Deputy Commissioner for Policy. Register here.

• Seven percent increase in BA Funding for FDA in FY 23.

• The Battle for House Speaker Has Implications for Appropriations.

• ARPA-H: FDA Support Will Be Reimbursable.

• Coming soon: Details on the Alliance’s FY 24 FDA Budget Webinar Series.

This week’s Analysis and Commentary, entitled "The Alliance Believes in FDA Exceptionalism. You Should Too,” looks at whether FDA is exceptional among federal agencies, worthy of special consideration when federal funding is allocated. It concludes that FDA exceptionalism is fully justified and needs to be a key feature of the Alliance’s advocacy and educational work.
 
Alliance’s first webinar of 2023: January 13 at 11:30 a.m. with Andi Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs at FDA. Register here. In most previous user fee renewal cycles, the final legislation was a combination of 1/ user fee program reauthorizations, and 2/ other Congressional policy and program improvements that were separate from, and not funded by, user fees.

However, the “other policies and program” provisions of the House and Senate-passed bills were dropped from the user fee legislation passed in September.

Some of the earlier provisions were added to the just-enacted Omnibus Appropriations legislation. Anything that did not advance will need to start anew with the 118th Congress this year.

The Alliance webinar on January 13 at 11:30 will feature Andi Fristedt, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs. In addition to explaining the functions of her office, she will address what happened in September and December and what she expects will be the FDA’s legislative priorities for 2023.

Seven percent Increase in BA Funding for FDA in FY 23. In the December 23, 2022, Friday Update, we analyzed the just-passed Consolidated Appropriations Act, 2023 (Public Law 117-328), under which FDA received a $226 million increase in BA funding. At the time, we said this was a 6.5% increase. We re-did our math, and it is more accurate to characterize the increase as nearly 7%. Our complete coverage is here and here.

Battle for House Speakers Has Implications for Appropriations.  As this is written, the House is still trying to resolve whether Kevin McCarthy (R-CA) will be the next Speaker of the House. Reportedly, the twenty or so “never Kevin” proponents are asking for (among other things) concessions in how the House considers appropriations bills.

We do not know all the details, nor have discussions led to an agreement. We expect to provide analysis once any set of changes are announced and finalized.

Meantime, most analysts have focused on the possible consequences for House process, without considering how changes might affect the Senate. According to our research, the Senate has not had a floor vote on even a consolidated appropriations bill since October 2019. Instead, the Senate has relied on the House to initiate funding bills and set benchmarks for negotiations.

ARPA-H: FDA Support Will Be Reimbursable. The just-enacted Consolidated Appropriations Act, 2023, provides a clear statutory based for the creation of ARPA-H, while placing the new research organization within NIH. We have long argued that the new agency will need significant FDA involvement to succeed. Our rationale is here.

Partly as a result of our efforts, the new law contains provisions (Part J—Advanced Research Projects Agency-Health, Section 499A., subsection (f)) that would facilitate cooperation between ARPA-H and FDA and provide a basis for FDA to be reimbursed from ARPA-H funds for its efforts.   
     
Coming soon: Details on the Alliance's FY24 FDA Budget Webinar Series.  We expect the President’s FY 24 Budget Request to be released in February or early March. In the weeks that follow the release, the Alliance will hold budget briefings with all five center directors and the Associate Commissioner for Regulatory Affairs.

We have run these programs for several years and they are among the most informative webinars that we sponsor. Details and registration information will be in forthcoming issues of Friday Update.