One Week CR; FY23 Approps Looks Hopeful; Elections Complete

Continuing Resolution Extends Interim Funding Until December 23.

  • FY 2023 Appropriations Looking Hopeful.

  • House Elections Complete.

  • Scottish Food Agency Cuts Services for Lack of Resources.

  • Transcript Available from Alliance Webinar with Valerie Jensen, Associate Director of FDA’s Drug Shortage Staff.

  • CY23 Invoices Sent to Alliance Members.

  • Upcoming Publication Schedule for Friday Update.

This week’sAnalysis and Commentary describes how the Alliance works to strengthen FDA and why the Alliance needs your support.
 
Continuing Resolution Extends Interim Funding Until December 23. The House and Senate passed legislation to extend the end-date on the Continuing Resolution from December 16 to December 23.  It has long been rumored that this would be necessary because appropriators were finding it difficult to agree on a total budget level and the split between defense and non-defense spending.

FY 2023 Appropriations Looking Hopeful. House and Senate Appropriations leadership have announced the general framework of an agreement that will allow full year appropriations for FY 23.  The one-week extension of the CR to December 23 should provide the time needed for completion of the Omnibus Appropriations Bill.

As of Friday, December 16 (today), no announcements have been made about specific funding levels: total, defense/non-defense split, and subcommittee allocations. Those are expected on Monday, December 19, 2022. The gives appropriators only 4 days to complete work, pass an omnibus bill through the House and Senate, and send it to the President.

While that seems an impossible task, we assume that subcommittees have already done most of the hard negotiating, needing only subcommittee allocations to finalize their bills.

While other matters are expected to be added to the Omnibus, no specific announcements have been made. A number of possible add-ons could impact FDA, noteably whether House E&C and Senate HELP can negotiate an agreement on the policy and program language stripped from the September’s user fee reauthorizations.

Even if such an agreement is reached, uncertainty remains whether it will be added in the omnibus in the face of dozens of Members and interest groups trying to add their priorities to the Omnibus bill.

House Elections Complete. The election of Congresswoman Lauren Boebert (R-CO) gives the Republicans a slim majority of 222 to 213 in the House.   Committee chairs and ranking members should be announced over the next few weeks following action by the House Republican Steering Committee and the House Democratic Steering and Policy Committee.

Scottish Food Agency Cuts Services for Lack of Resources. Food Safety News reports that the Scottish Food Agency has cut back its workplan and prioritized certain services for lack of resources. The article suggests the agency may have no recourse to receive additional funds.

This is a useful reminder that government agencies are never guaranteed sufficient resources. For that reason, the Alliance has two missions: advocate for increased budget authority appropriations for FDA and educate about FDA’s broad mission and growing responsibilities. Our efforts have been instrumental in the doubling of FDA’s annual BA funding from $1.6 billion to more than $3.3 billion.

If you are not a member—we need you. Every additional voice on behalf of the FDA matters. For more information, check out our website,www.strengthenfda.org or contact me directly at sgrossman@strengthenfda.org. This week’s Analysis and Commentary is also devoted to why the Alliance needs your support.

Transcript Available from Alliance Webinar with Valerie Jensen, Associate Director of FDA’s Drug Shortage Staff. On December 1, 2022, the Alliance for a Stronger FDA hosted a widely attended webinar on drug shortages with Valerie Jensen, the Associate Director of FDA’s Drug Shortage Staff. In her wide-ranging review of this important topic, Ms. Jensen discussed reasons for shortages, the role of the Drug Shortage staff, steps taken to respond to these shortages, and other key questions. She also responded to several audience questions.

More information about FDA’s drug shortage program can be found here. The transcript can be found here.

CY23 Invoices Sent to Alliance Members. Please keep an eye out for your invoice for Alliance 2023 dues. Please let Elisa know if you haven’t received an invoice or cannot find it.

Upcoming Publication Schedule for Friday Update. Today’s edition—December 16, 2022—is the last regularly scheduled Friday Update for this year. We will restart weekly editions on January 6, 2023.

In between, we will publish a special edition of Friday Update as soon as we have accurate information about the impact on FDA of Congressional action on FY 23 funding. In that edition, we will also include any information about the fate of the policy and program provisions that had been stripped from the user fee legislation in September and are now under negotiation for inclusion in an end-of-Congress package.      

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Webinar with Valerie Jensen, Associate Director of FDA’s Drug Shortage Staff