Dr. Califf's nomination; FY 22 appropriations and “Build Back Better” status; food safety updates.

Top-Line:

  • Analysis and Commentary reviews the Alliance’s 2021 activities.

  • Senate HELP Committee vote on Califf nomination scheduled for January 12.

  • Legislative status on appropriations and the “Build Back Better” reconciliation bill.

  • Two new Alliance webinars announced:

    • Acting FDA Chief Scientist Dr. Jacqueline O’Shaughnessy on January 25.

    • "How FDA Is Funded” on February 2.

  • Newly published guide to understanding the Federal budget process.

  • Food safety updates from FDA: the importance of science.

This week’s Analysis and Commentary (below) is devoted to progress on FDA funding in 2021 and the Alliance’s activities to increase policymaker and public understanding of the FDA’s mission and responsibilities.

Committee Vote on Califf Nomination Scheduled for January 12. The Senate HELP Committee has scheduled an executive session at 10 a.m. on January 12 to vote on a number of nominations. Among them is Dr. Robert Califf’s nomination to be the next FDA Commissioner. The location of the executive session has not been announced and, according to the committee website, the session will not be webcast.

Legislative Status: Appropriations. The Alliance continues its focus on the fate of FDA’s FY 22 appropriations, in which the agency is slated to receive at least a $200 million increase in budget authority (BA) funding, subject to House and Senate agreement on overall spending levels. The current Continuing Resolution (CR) extends through February 18 and there is ample concern that a further CR might be needed or that Congress might choose to adopt a full-year CR. A mitigating factor against a full-year CR is that Members would lose the earmarks in current bills—in the first year that the practice has been restored—unless appropriations bills are adopted.

Discussions have foundered on defense funding levels and policy riders. Recent reports indicate that the House Appropriations Committee may be willing to provide $740 billion for defense, which is $25 billion above President Biden's request. If so, this could increase the likelihood that full-year spending bills could be agreed to by February 18 or soon thereafter.

Legislative Status: Reconciliation. We are also closely monitoring discussions about how the Senate may proceed on the Build Back Better (BBB) reconciliation bill. As we have reported previously, the Alliance’s interest is in Section 31023 of the House-passed BBB bill, which includes $300 million in no-year money for infrastructure improvements for FDA. Half would go to technology and data modernization and the other half to facilities and physical improvements. The draft Senate HELP Committee bill includes this FDA provision, as well (Sec. 28023).

Alliance Webinars: First Two Announced for 2022. We have our first and second webinars for the year scheduled:

  • Acting FDA Chief Scientist Dr. Jacqueline O’Shaughnessy on Tuesday, January 25, 2022, at 1 p.m. To join us, please sign up here.

  • “How FDA Is Funded” featuring Alliance Board Member Emily Holubowich and Executive Director Steven Grossman on Wednesday, February 2, 2022, at 3 p.m. To join us, please sign up here.

These online events are produced for Alliance members and media, though we welcome guests. If you are not a member and would like to participate, please contact Alliance Executive Director Steven Grossman


Newly Published Guide to Understanding the Federal Budget Process. The Congressional Budget Office has recently published an explanation of key terms that are central to understanding the federal budget. Most Friday Update readers understand the distinction between mandatory and discretionary spending and the relationship between budget authority and appropriations. However, most of us could use a refresher on the differences among cash accounting, accrual accounting, and fair-value accounting and among cost estimates, dynamic analysis, and scorekeeping.

Food Safety Updates from FDA. In mid-December, Food Safety News published an overview of FDA’s food safety initiatives, written by Frank Yiannis, Deputy Commissioner for Food Policy and Response. One of his points is that scientific advances are making improved food safety possible. “Public health advancements, such as whole-genome sequencing (WGS), have improved our ability to detect foodborne outbreaks and allowed us to recognize that some of the outbreaks identified today may have previously gone undetected in the past. WGS has also allowed the agency to detect some outbreaks sooner compared to previously used laboratory methods and allows us to detect new and novel food vehicles of foodborne disease.”

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2021 Activities Recap: advocacy, education, and media

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Summary of: Alliance webinar with Dr. Susan Mayne on FDA nutrition programs