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Advocacy at a Glance

February 5, 2021

Top-Line: The Senate has announced committee assignments. Senator Merkley will chair the Ag/FDA Appropriations Subcommittee and Senator Hoeven will be the Ranking Member. The FY 22 funding cycle has started at the staff level, but both House and Senate have other business to address before the process can get underway. The Alliance is soliciting input from its members about what they see as the FDA’s priority funding needs for FY 22. GAO has made a set of recommendations concerning FDA inspection practices.

Senate Power-Sharing Agreement Finalized; Democrats Become Majority Party. Senate assignments have now been finalized. Senator Merkley will chair the Ag/FDA Appropriations Subcommittee and Senator Hoeven will be the Ranking Member. Our congratulations to both of them. We look forward to working with them to make the FDA stronger and better resourced to assure that the agency can fulfill its mission and responsibilities.

FY 22 Funding Cycle: Multiple Distractions Before Congress Digs In. While staff have started work on FY 22 funding issues and the new Administration is putting its FY 22 budget request together, there will still be plenty to occupy Congress, especially the Senate. The House and Senate have just passed their FY 21 Budget Resolution and multiple committees are expected to quickly start to address the reconciliation instructions they have been given. The Senate has the impeachment trial next week and is also working through confirmation hearings/votes for President Biden’s nominees.

Alliance Begins Process of Formulating FY 22 “Ask;” Solicits Input from Its Members. This is going to be a difficult year for FDA to receive a significant increase in its budget. However, it is also a time (new administration, mid-pandemic, extraordinary pressures on the agency, accelerating growth in new science) in which it is essential that we lay out a bold agenda of FDA’s needs and opportunities for FY 22 and the years beyond that.

This week’s Analysis and Commentary looks at some possible themes and initiatives that the Alliance may want to consider advancing for FY 22. We hope this will stimulate Alliance members to tell us what they consider the most important FDA funding priorities — whether discussed below or derived from your own experiences and thinking. Alliance members are encouraged to send their thoughts, preferably by February 22, to Steven Grossman at the Alliance.
 
GAO Recommends Changes in FDA Inspection Practices. As reported by Regulatory Focus, GAO made two recommendations to FDA related to inspections during and beyond the pandemic. First, GAO calls on FDA to fully assess its alternative inspection tools and “consider whether these tools or others could provide the information needed to supplement regular inspection activities or help meet its drug oversight objectives when inspections are not possible in the future.” Second, GAO frets that a looming backlog of inspections could jeopardize the agency’s strategic goal of shifting more of its inspections to a risk-based model and instructs the agency to assess its inspection plans for the coming years.

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