Warnock Reelected; FY23 Approps at an Impasse; Response to Reagan-Udall Foundation’s Report

• Warnock Reelected in Georgia; House Race Still Outstanding.

• FY 2023 Appropriations at an Impasse.

• Alliance Responds to Reagan-Udall Foundation’s Food Report.

• Guidance on Digital Health, Cybersecurity, and New Technologies: Some Draft, Some Final. 

This week’sAnalysis and Commentaryis entitled “Webinar with Valerie Jensen, Associate Director of FDA’s Drug Shortage Staff” and summarizes last Thursday’s webinar. For more detail,  please contact the Alliance for the recording or transcript.

Warnock Reelected in Georgia; House Race Still Outstanding.Senator Raphael Warnock has won reelection in the Georgia runoff, giving Democrats a 51-49 Senate Majority in the 118thCongress. Sen. Kyrsten Sinema (AZ) has now announced that she is changing her party affiliation to independent but is expected to continue to caucus with Democrats. We expect that Democrats will now also have a one seat majority on each of the Senate Committees, as opposed to the equal number of Democrats and Republicans on each committee in the current Congress. Current election results in the House give Republicans a slim majority of 221 to 213. Appointments of members to committees will be announced in the coming weeks and we will provide that information as it becomes available.
 
FY 2023 Appropriations at an Impasse.Appropriations leadership remains $26 billion apart on the top line number for nondefense spending, with just one week to go before the current Continuing Resolution (CR) expires. Senate Appropriations Chair Leahy and House Appropriations Chair DeLauro reportedly will introduce their own omnibus appropriations bill on Monday, which likely would pass the House but not the Senate. Some suggest that another CR through December 23 will be necessary to provide time to complete negotiations and draft the actual bill. And there has been an increasing number of statements suggesting that a full year CR is a possibility—although such action would have to overcome vehement opposition from the Department of Defense 

As we explained inlast week’s Analysis and Commentary, the consequences of a CR can be  severe, even though CRs are usually temporary. The agency is currently conducting FY23 programs under FY22 (prior year) funding levels. They do not have the benefit of the increased monies proposed for FY23 by the President and both the House and Senate.

Alliance Responds to Reagan-Udall Foundation’s Food Report. On December 6, the Reagan-Udall Foundation released its Expert Panel Report on improving FDA’s food safety and nutrition program (here). The report was generally well-received as a starting point, with stakeholders focused on FDA and Commissioner’s Califf buy-in on recommended changes.
The Alliance responded to media requests for comment, emphasizing resource needs and the connection between resources and reform.

• Resources:

  • FDA’s food safety and nutrition programs are underfunded…both to 1/ fulfill current responsibilities and 2/ implement programs to achieve a safer and healthier food supply in the U.S.

  • The proper metric for increased funding for food safety and nutrition programs is what is needed to achieve a safer and healthier food supply. All other comparisons are distractions.

• Reform:

  • There is a strong consensus—in government as well as among members of the Alliance—that FDA needs to fundamentally change its food safety and nutrition programs.

  • Reform and increased resources are necessary complements: money without reform will fail, but reform without money will also fail.

The Alliance added: “Old programs, though inadequate, will need to be maintained while new structures, new programs, and new leadership is put in place. That is impossible to do within the current funding.”

Further background:  The Alliance for a Stronger FDA testified before the Reagan-Udall Foundation panel on September 30. Subsequently, we published three Analysis and Commentary columns exploring why increased funding and reform are both needed in 2023: The F in FDA, Part 2 and Part 3.

Guidance on Digital Health, Cybersecurity, and New Technologies: Some Draft, Some Final. As reviewed by Politico’s Agency IQ in an extensive analysis: regulators, experts and industry leaders discussed digital health product regulation and FDA’s new final guidance on Clinical Decision Support (CDS) at a conference sponsored by the Food and Drug Law Institute. Regulators also offered insights about when industry can expect 1/ draft guidance on artificial intelligence  and machine learning (AI/ML) and alternate, virtual, and extended reality technology (AR/VR/ER), and 2/ final guidance on cybersecurity. Interested readers may also want to review the summary and transcript of the Alliance’s October 20 webinar with Dr. Suzanne Schwartz, whose office in CDRH oversees cybersecurity and digital health. FDA’s information page on AR/VR/ER is here.