Senate Committee approves FY 22 Agriculture/FDA Appropriations Bill; Alliance expresses support for Congressional funding of FDA;
Top-Line:
Senate Committee approves FY 22 Agriculture/FDA Appropriations Bill.
The Alliance appreciates increased FDA funding.
Congressional schedule limited between now and the new fiscal year.
The interaction of budget, appropriations, and reconciliation.
ARPA-H still drawing attention.
No Friday Update on August 13.
Senate Mark-Up Continues Strong Support for FDA in FY 22. The full Senate Appropriations Committee approved S. 2599, funding FDA and agriculture programs, on Wednesday, August 4. Following are highlights from the report accompanying the bill:
The Committee recommends an appropriation of $3,399,428,000 for salaries and expenses of the Food and Drug Administration.
The Committee provides a net increase of $17,900,000 for pay costs; $7,500,000 for infrastructure; $8,000,000 for Data Modernization and Enhanced Technology [DMET] New Era for Smarter Food Safety; $3,000,000 for New Era for Smarter Food Safety; $7,000,000 for Animal Food Safety Oversight; $14,050,000 for Maternal and Infant Health; $12,750,000 for Emerging Chemical and Toxicology Issues; $2,000,000 for Animal Feed Reviews; $5,000,000 for Standards of Identity; $10,000,000 for Device Shortages and Supply Chain; $2,300,000 for Medical Product Supply Chain; $2,000,000 for Drug Safety Surveillance and Oversight; $24,000,000 for Opioids; $7,500,000 for Predictive Toxicology Roadmap; $5,000,000 for DMET Medical Product Safety; $25,000,000 for DMET Enterprise Wide; $15,000,000 for Inspections; $4,700,000 for the Office of Minority Health and Health Equity; $3,000,000 for Laboratory Safety; $3,000,000 for the Office of the Chief Counsel; $500,000 for BioFilm Regulatory Research; $5,000,000 for Rare Cancers; $5,000,000 for Rare Diseases; and $8,300,000 for Essential Services.
What the Alliance Said About the Senate Ag/FDA Funding bill. A statement released by the Alliance said: “The Subcommittee mark represents a strong commitment by the Senate to FDA’s resource needs and is consistent with the Alliance’s FY 22 request that FDA receive no less than a $200 million increase in BA funding. The Senate Subcommittee started with a significantly lower budget allocation than the House. However, both bodies chose to provide slightly more than 13% of their available funds to FDA.” A more detailed chart capturing Alliance analysis can be found here.
Limited Congressional Schedule Between Now and the New Fiscal Year. The House is back the week of August 31 for committee days (no floor business). They will return again for committee days on September 9, 10, 13, 14. There will be no full House session until September 20. It is unclear whether the Senate will make its target for August recess to start today (August 6). The current Senate calendar calls for them to return on September 13.
Budget, Appropriations and Reconciliation -- How They fit together? Why It Matters? With both House and Senate on a path to provide FDA with a $200+ million increase in FY 22, FDA would appear to be on an excellent trajectory for this coming fiscal year. However, there is still the key question of how to lock in those numbers and make sure those resources reach the agency in a timely fashion. The answer lays in the interplay among 1) the Congressional budget resolution, 2) annual appropriations legislation, and 3) budget reconciliation. Each will be prominently in the news over the next 8 weeks, but the relationships among them are not easily understood and are rarely explained. Yet, they will be critical to FY 22 funding. Accordingly, this week’s Analysis and Commentary explores each of these legislative processes and how they might affect FDA funding.
ARPA-H Still Drawing Attention. In last week’s Friday Update, we reviewed the background and key questions surrounding ARPA-H, including the role of FDA. With specific regard to the Alliance and the FDA’s role, we stated: “The Alliance’s purpose is to 1) educate policymakers, media, and the public about FDA’s mission and responsibilities and 2) advocate for increased budget authority appropriations. Accordingly, and appropriately, the Alliance is neither a proponent nor an opponent of the creation of ARPA-H. However, the Alliance wants to be sure that the FDA stakeholder community is aware of the need for additional resources for FDA if ARPA-H is created.”
No Friday Update Next Week. We will not be publishing Friday Update on August 13. Look for the next issue on August 20. Even though we are not publishing, Alliance staff will be available to meet member needs.
