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

  • Ag/FDA Bill Slated for House Action as Part of Minibus.

  • Chair DeLauro on Expectations for FY 23 Appropriations.

  • Principal Deputy Commissioner Woodcock to Address Alliance on FDA’s Data, Technology, and Enterprise Modernization Plans: August 4 from 3:00 to 4:00 P.M. (Register here).

  • Path for User Fee Reauthorization Becomes Less Certain.

  • FDA Reports Significant Progress in Reducing Drug Shortages.

  • Want to Know More About FDA? Alliance’s New Website Delivers www.strengthenfda.org


Ag/FDA Bill Slated for House Action as Part of Minibus. The House Appropriations Committee announced that half of the committee’s twelve funding bills will be considered by the House during the week of July 18. Among them is the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill.
 
The House Rules Committee is scheduled to meet on Monday, July 18 to determine which amendments will be considered. The Committee announcement already shows the six bills combined into a minibus, HR 8294.

Chair DeLauro on Expectations for FY 23 Appropriations. As reported by Roll Call, House Appropriations Committee Chair DeLauro, is focused on moving all 12 appropriations bills through the House in the next two weeks, prior to the House August recess. The first six of those bills will be on the floor the week of July 18 and are expected to pass easily. The other six, likely to be taken up the week of July 25, include three that have uncertain prospects (Commerce/Justice; Defense; and Homeland Security).
 
Meantime, the same article reports no progress in bicameral, bipartisan negotiations on total budget spending and policy riders. As a result, the Senate, according to Senate Appropriations Committee Chair Leahy, is planning to forgo markups and release the 12 Senate fiscal 2023 spending bills at the end of July.
 
Principal Deputy Commissioner Woodcock to Address Alliance on FDA’s Data, Technology, and Enterprise Modernization Plans for the FDA: August 4 from 3:00 to 4:00. Dr. Woodcock will explain and provide updates on the 2019 Technology Modernization Action Plan (here); the 2021 Data Modernization Action Plan (here); and the 2022 Enterprise Modernization Action Plan (here). She will also provide insight into how each of these action plans (individually and combined) contribute to better and more efficient decisionmaking by FDA.
 
Dr. Woodcock’s remarks will be open to Alliance members and media. (Register here). The Alliance welcomes guests at our events. If you are not an Alliance member and would like to attend, please contact Alliance Executive Director, Steven Grossman.
 
Path for User Fee Reauthorization Becomes Less Certain. The Alliance has spoken out (see last week’s Friday Update) about the importance of completing user fee reauthorization by August 1, the date at which 60-day lay-off notices would go to many FDA employees.  However, completion before September seems increasingly unlikely. In response, Senator Burr introduced legislation that would reauthorize user fees without any extraneous provisions.
 
In response to a media inquiry, Alliance Executive Director Steven Grossman stated: “Over the last few user fee reauthorization cycles, the legislative vehicle containing the user fees has provided a means for Congress to adopt many important provisions that have strengthened FDA and improved the agency’s ability to protect the health and safety of Americans. There are many such provisions in the current House and Senate versions of the legislation.
 
However, the only essential task for Congress is the reauthorization of the user fee agreements. Without that, lay-off notices will go to several thousand FDA employees on August 1. Then on October 1, there is the possibility that those individuals would no longer have jobs and there would be a nearly $2 billion hole in the agency’s budget.
 
Stakeholders do not decide what happens--this rests solely on the shoulders of Senators and Representatives. We can only hope the net impact is positive for both FDA and the American people.”

FDA Reports Significant Progress in Reducing Drug Shortages. As reported by Endpoints News, FDA has delivered a report to Congress that acknowledges continued problems with drug shortages, while also documenting areas of significant progress.  A key advance is that “manufacturers are notifying FDA earlier than in the past about certain manufacturing interruptions and discontinuances that can lead to shortages. These early notifications give FDA additional time to work with manufacturers and other stakeholders to identify ways to maintain treatment options and prevent a shortage.”
 
Want to Know More About FDA? Alliance’s New Website Delivers www.strengthenfda.org. On the site you can find transcripts and/or summaries of all seventeen webinars that the Alliance has held since April 2021. The webinars are hour-long programs with senior FDA leadership. Whatever part of FDA you are interested in, it has been covered by one of our speakers. Go to the Alliance’s Events page here.

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