Some Likely Questions at the Alliance Webinar with the Commissioner; Feedback on Alliance Senate Visits

Commissioner Califf to Address Alliance for a Stronger FDA: July 12 from 1:30 to 2:30 P.M. Register here. The Alliance exists for two purposes: to advocate for increased budget authority appropriations and other resources for FDA; and to educate policymakers, media, and the public about FDA’s mission and responsibilities.

Consistent with that, here are some of the topics and questions that we hope Dr. Califf will address:

  1. What is your vision for FDA in 3 to 5 years? What does the agency need to start doing now to reach that vision?

  2. Does FDA have the resources it needs in FY 22? What are your most pressing funding requests for FY 23?

  3. What can you tell us about your priorities relative to food safety programs?

  4. What is your approach to keeping food safety and medical products moving forward when the FDA is in the headlines almost every day with regard to tobacco control and abortion?

  5. The Alliance has been a strong supporter of FDA’s funding requests for data and technology modernization. What have been the most effective points in gaining support for this pressing need?

  6. FDA has a commitment to increase diversity. What does that mean and how is it being implemented?

Join us on July 12 and find out whether Dr. Califf addresses these questions. Register here

Feedback on Alliance Senate Visits. In anticipation of Senate action on FY 23 FDA appropriations bills, the Alliance for a Stronger FDA recently met with the offices of a dozen Senate appropriators. Here are the messages we delivered, putting particular emphasis on our support for the funding increases of $341 million in the FY 23 Ag/FDA funding bill that has passed the House Appropriations Committee. We emphasized the immediate needs for data and technology modernization. We also focused on the need for FDA’s hiring of skilled professional staff, as expressed in the statement previously submitted (here) to the Senate Agriculture, Food and Drug Administration, and Related Agencies Appropriations Subcommittee.

These meetings were well received and informative. In some offices, it was important to explain the different purposes of BA funding and user fees.

No office was able to provide information regarding a schedule for appropriations action in the Senate. Instead, multiple offices suggested that the process could be similar to last year. At that time, the Senate Appropriations Committee acted, but the full Senate did not move on final bills until the development of the Consolidated Appropriations Act of 2022 which was signed into law on March 15, 2022 – nearly halfway through the fiscal year.

It has been reported, but not confirmed, that Appropriations Committee Chairman Leahy plans to provide the subcommittees with their respective subcommittee allocations, so that July mark-ups are possible. This is an effort to keep the appropriations process moving. In addition, it would speed final resolution once there is a bipartisan budget agreement. Many offices foresee level-funding under a Continuing Resolution (CR) at the start of the new fiscal year.

The Alliance hopes to schedule additional meetings with House and Senate Appropriations offices before the new fiscal year begins. We encourage Alliance members to join Alliance staff in those meetings. Let us know of your interest, by contacting Elisa Bayoumi.

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Ag/FDA FY23 Approps Update, User Fee Reauthorization Uncertainty, and Dr. Woodcock Webinar Announcement

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House and Senate Calendar Updates; Understaffed FDA Offices; Inspections Updates