FDA May Gain $300 Million for Infrastructure from House Reconciliation Bill; Update on Status of FY 22 FDA Appropriations
Top-Line:
FDA May Gain $300 Million for Infrastructure from Revised House Reconciliation Bill
Update on Status of FY 22 FDA Appropriations.
More on ARPA-H and FDA.
Upcoming Alliance Webinars - Oncology Center of Excellence Deputy Director Paul Kluetz November 15, 3:30-4:30 PM ET; Director of the Office of Tissues and Advanced Therapies at CBER Wilson Bryan, MD December 6 at 10 a.m.; Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne December 14 at 2 p.m.
Alliance Webinar Spotlighting NCTR: Transcript Available.
Analysis and Commentary - Implications for FDA under ARPA-H
BREAKING STORY: FDA May Gain $300 Million for Infrastructure from Revised House Reconciliation Bill. The House has released a revised reconciliation bill that reflects a top-line consistent with President Biden’s endorsement of a bill about half the size of the original $3.5 trillion proposal. The revised bill contains $300 million for FDA infrastructure that was not in previous versions of the bill.
Specifically, Section 31023 of the modified Build Back Better Act provides $150,000,000 for “improving technological infrastructure, including through developing integrated systems and improving the interoperability of information technology systems,” and $150,000,000 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.”
The schedule for further House action is yet to be determined and the fate of the entire reconciliation process is uncertain. These new provisions respond to FDA’s needs—as articulated in the FY 22 budget request—for a major infusion of money for technological and physical infrastructure. The proposed new funds are no-year investment monies, but do not supplant the need for ongoing funding that would go into FDA’s base appropriation.
Update on Status of FY 22 FDA Appropriations. 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.
Reportedly, House and Senate Appropriation Subcommittee staffs have begun to preconference House and Senate bills in anticipation of completing them prior to December 3. However, final resolution is subject to House and Senate agreement on total discretionary spending and subsequent allotment to each subcommittee within that total. Until that is resolved, the House and Senate positions are nearly $700 million apart out of a total allotment to Ag/FDA programs of about $26 billion.
While House and Senate subcommittee leadership has expressed some optimism about the potential for putting together an omnibus by December 3, there is also speculation that there may be a need to extend the CR for an additional two weeks for the final bill to be completed.
More on ARPA-H and FDA. As we have reported previously, President Biden has proposed setting up 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, break-through advances. The President proposed $6.5 billion to begin with, while House appropriators have set-aside $3 billion and the Senate appropriators $2.5 billion. While these monies are in the appropriations bills that are moving forward, 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 has the resources to be a full partner. This week’s Analysis and Commentary explores various aspects of the DARPA model, the progress of legislation, and why we think a robust FDA role is critical to ARPA-H success.
Upcoming Alliance Webinars. The Alliance is pleased to host FDA leadership to address the Alliance members and media in these upcoming webinars.
Oncology Center of Excellence Deputy Director Paul Kluetz is scheduled for November 15, 3:30-4:30 PM ET. The FDA Oncology Center of Excellence leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, devices, and diagnostics. The Center helps expedite development of medical products for oncologic and hematologic malignancies and supports an integrated approach to their clinical evaluation. Alliance members and media can register here
Director of the Office of Tissues and Advanced Therapies at CBER Wilson Bryan, MD is scheduled for December 6 at 10 a.m. His office is the front-line in the development of gene therapies. Sign up here.
Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne is scheduled for December 14 at 2 p.m. She will be discussing FDA’s nutrition programs and major initiatives in that area. Sign up here.
Non-members interested in participating in any of these events should contact Alliance Executive Director Steven Grossman at: sgrossman@strengthenfda.org.
Alliance Webinar Spotlighting NCTR: Transcript Available. On October 15, the Alliance welcomed Dr. William Slikker, Jr. who leads FDA’s National Center for Toxicological Research for a webinar to explore the center’s programs and priorities. A transcript of that session can be found here.