Q&A Updates: Appropriations, Reconciliation, and ARPA-H
Updates: Appropriations, Reconciliation, and ARPA-H
Q: What is the status of annual appropriations and the continuing resolution?
A: As reported last week, the FDA (along with the rest of the federal government) is operating through December 3 under a Continuing Resolution. This provides funding for FDA at FY 21 levels and is subject to limitations on new initiatives.
The House on July 29 passed HR 4502, the FY2022 Consolidated Appropriations Act, including the Ag/FDA programs, by a vote of 219-208. That measure included a $257 million increase in budget authority (BA) funding for FDA. The Senate Appropriations Committee on August 4 favorably reported S. 2599, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022, which included a $200 million increase for FDA. Both bills, therefore, are consistent with the Alliance’s FY 22 “ask” for an increase of not less than $200 million.
House and Senate Appropriation Subcommittee staff have reportedly begun to preconference House and Senate bills in hopes of completing them prior to December 3. However, the final resolution is subject to House and Senate agreement on total discretionary spending and subsequent allotments to each subcommittee within that total. Until that is resolved, the House and Senate positions are nearly $700 million apart out of a total House allotment to all Ag/FDA programs of about $26.5 billion.
While House and Senate subcommittee leaders have expressed guarded optimism about the potential for putting together an omnibus by December 3, there is also speculation that a two-week CR extension may be necessary for a comprehensive, final bill to be completed. House and Senate full Appropriations Committee leadership met this week to discuss the outlook for completing an omnibus bill by December 3, but that meeting came to no resolution.
Q: Where do things stand for FDA in the revised reconciliation bill?
A: While numerous changes have been made in the updated Build Back Better Bill submitted to the House Rules Committee this week, the bill continues to provide $300 million for FDA infrastructure. Specifically, Section 31023 of the modified Build Back Better Act provides $150 million for “improving technological infrastructure, including through developing integrated systems and improving the interoperability of information technology systems,” and $150 million for “modernizing laboratory infrastructure of, or used by, FDA, including modernization of facilities related to, and supporting, laboratory infrastructure, including through planning for, and the construction, repair, improvement, extension, alteration, demolition, and purchase of, fixed equipment or facilities.”
When the full House will proceed to a final vote on this bill is yet to be determined.
Q: What is the latest on ARPA-H?
A: As we have reported previously, President Biden has proposed a new biomedical research agency, the Advanced Research Projects Agency for Health (ARPA-H). It is modeled on the long-standing and successful Defense Advanced Research Projects Agency (DARPA) which tackles large, difficult problems with the goal of quick, breakthrough advances.
The President initially proposed $6.5 billion for the effort. Since then, House appropriators have set aside $3 billion and the Senate appropriators $2.5 billion. While these monies are in the pending appropriations bills, none of these dollars can be spent until the House Energy and Commerce Committee and the Senate Health Committee authorize the agency and that legislation becomes law.
The Alliance for a Stronger FDA has no position on whether ARPA-H should be created (it is outside our mission). However, if ARPA-H does come into existence, we want to be sure the FDA is allocated the resources to be a full partner.
Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.