COVID relief legislation becomes law, providing $500 million in no-year money to support FDA’s work on COVID and related items.

HHS Secretary-Designate Xavier Becerra is likely to be confirmed next week. Senator Baldwin received positive back-home press. GAO’s report highlights the need for FDA to ramp up inspections once the pandemic threat has receded. FDA releases its Data Modernization Action Plan (DMAP), a critical foundation for FDA’s growing challenges and opportunities. This week's Analysis and Commentary explores DMAP.

COVID Relief Bill Becomes Law. Under the legislation, FDA will receive $500 million in no-year monies to continue and expand pandemic-related work. Thank you to the many Congressional supporters of the FDA who made this possible. Activities for which the money could be spent include:

1. The evaluation of the continued performance, safety, and effectiveness of vaccines, therapeutics, and diagnostics for use for the treatment, prevention, or diagnosis of COVID–19

2. Facilitation of advanced continuous manufacturing activities related to the production of vaccines and related materials

3. Facilitation and conduct of inspections related to the manufacturing of vaccines, therapeutics, and devices delayed or cancelled for reasons related to COVID–19

4. Review of devices authorized for use for the treatment, prevention, or diagnosis of COVID–19, and

5. Oversight of the supply chain and mitigation of shortages of vaccines, therapeutics, and devices for the treatment, prevention, or diagnosis of COVID–19 by the FDA

As we discussed here, these monies are essential for FDA to move forward in the pandemic, but do not lessen the budget and personnel needed by the agency. COVID apart, FDA’s mandate in FY 22 will be larger than it was in FY 20 or FY 21.

Becerra's Nomination for HHS Secretary Advances. HHS Secretary-Designate Xavier Becerra’s nomination advanced on a 51-48 vote that permits a confirmation vote next week (Politico coverage here). The procedural vote is widely seen as assuring a narrow but positive result for confirmation.

Senator Baldwin Satisfies Back-Home Needs by Chairing Ag/FDA Appropriations. As the only new Member to the leadership overseeing FDA funding, Senator Baldwin’s assignment was a surprise, driven by a change in Senate Democratic rules for committee assignments. However, as described here, there is a strong rationale and lots of Wisconsin support for her choice. Alliance advisor Phil Karsting of OFW Law is quoted in the article, reflecting his Wisconsin connection and prior work when Wisconsin Senator Herb Kohl also chaired Ag/FDA Appropriations.

GAO Releases Report and Testifies on COVID-Related Delays in Inspections at FDA. At a House Ag/FDA Appropriations Subcommittee hearing, GAO released its report (here) and testified about COVID’s impact on FDA inspections. We are told that the agency plans to provide information soon on the priorities and timeframes for ramping back up.

Data Modernization Plan Released; Among FDA’s Highest Priorities. Following up its 2019 Technology Modernization Action Plan (covered here), the FDA has now released its Data Modernization Action Plan (here). Knowledge management and data modernization were already on the Alliance’s list of FDA areas needing additional funding in FY 22, so the report is timely. We presume that release of the Action Plan foreshadows data modernization being an important part of the President’s budget request for the agency. This week’s Analysis and Commentary looks more deeply at the Action Plan and FDA’s needs.