Commissioner Califf Testifies on FY23 Priorities; Responses to Infant Formula Shortage

Top-Line:

  • House Advances $28 Million Supplemental to Fund FDA Work on Infant Formula

  • Commissioner Califf Testifies Before House Appropriations Committee About FY 23 Funding Priorities and Infant Formula; Link to Full Summary

  • Alliance Encourages FDA Stakeholders to Submit Testimony to the House Ag/FDA on FY 23 Funding

  • Alliance Has More Hill Visits Planned in May and June; Seeking Sign-Ups

  • FDA Leaders Discussing FY 23 Budget Priorities and Other Alliance Webinars.

This week’s Analysis and Commentary summarizes the remarks of Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research at the May 10, 2022, webinar hosted by the Alliance for a Stronger FDA.


House Advances $28 Million Supplemental to Fund FDA Work on Infant Formula. The House passed an FY 22 Supplemental Funding bill this week that, among other things, includes $28 million for FDA to address the shortage of infant formula. According to The Associated Press, the monies would ensure federal regulators have the staffing to shore up inspections of U.S. and international suppliers, get better data on the marketplace and prevent the sale of fake products.

Commissioner Califf Testifies Before House Appropriations Committee About FY 23 Funding Priorities and Infant Formula. Link to Full Summary. The Alliance was pleased with Dr. Califf’s opening statement here “because it highlights the depth and breadth of challenges and opportunities facing the agency. We particularly note his emphasis on data and technology modernization—an essential investment if FDA is to maintain its global leadership.”

During the hearing itself, Commissioner Califf answered a broad range of questions. The Alliance has a full summary of the hearing. It can be found here.

Going forward, Subcommittee mark-ups will be followed by full Committee mark-ups. The House usually starts before the Senate. Usually, the House does this in early June, but sooner or later are both possible.

Alliance Members Encouraged to Submit Testimony to House Ag/FDA Subcommittee in Support of the Alliance’s FY 23 “Ask.” The Alliance for a Stronger FDA supports the Administration’s BA request of $3.653 billion. This provides for an increase of $336 million in budget authority (BA) funding. We also support an additional $20 million for the Cancer Moonshot. We already submitted Senate testimony that advocates for this position, here.

The Alliance encourages all members to submit testimony to the House in support of the Alliance's “ask” for FY 23 FDA funding. It is due by May 31, 2022. The House subcommittee has provided explicit directions about formatting and other submission details (here). In addition, Alliance staff welcomes requests for assistance in preparing testimony in support of FDA funding.
The best testimony intermixes broader points about FDA funding needs with specific examples of how a well-funded FDA advances programs that affect you or your organization. For more information on the key message points, check our May 6 analysis column and the two-page document that we have been using in Hill meetings, here.

Alliance Has More Hill Visits Planned in May and June; Seeking Sign-Ups. The Alliance conducted more than 50 Hill visits during March and April. We expect to do more later in May and in June. If you would like to be on our priority list to participate in these future Alliance Hill meetings, please contact Elisa Bayoumi.

FDA Leaders Discussing FY 23 Budget Priorities and Other Alliance Webinars. Altogether, the Alliance has held eight webinars, including an exclusive series with FDA leaders discussing their FY 23 budget priorities. We have audio, summaries and, in most cases, transcripts of these webinars. For more information, go to https://www.strengthenfda.org/events.

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What CBER Director Dr. Marks Said to the Alliance

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