Laddered Continuing Resolution Signed by President
This week’s Analysis and Commentary is entitled “Nothing Resolved. Everything Still on the Table.”
Steven’s Traditional Thanksgiving Message to the FDA Stakeholder Community (here). It begins: “....Consider adding thanks to FDA and its devoted staff, and special thanks to the inspectors who never get sufficient credit for the difficulty and potential danger in their jobs.”
Laddered Continuing Resolution (CR) Signed by President. The House on Tuesday by a vote of 336-95 and the Senate on Wednesday by a vote of 87-11 approved H.R.6363, Continuing Appropriations through early next year. The President signed the measure into law on Thursday.
This laddered approach sets the first spending deadline for four bills on January 19. Those bills include Agriculture/FDA, Military Construction and Veterans Affairs, Transportation and Housing and Urban Development, and Energy and Water appropriations. The remaining eight bills are funded through February 2.
The House is now in recess, with next votes scheduled for Tuesday, November 28. The Senate will meet only in pro forma sessions and will next meet on Monday, November 27.
Negotiations Will Come, But Many Uncertainties. The extension of the CR sets the stage for negotiations to begin, aimed at resolving differences between the House and Senate versions of funding bills. Since the first tranche of bills includes the Agriculture/FDA bill, that bill will be in the forefront of addressing the uncertainties.
Currently unresolved: which House and which Senate bills. The House has passed 7 funding bills–all of them controversial to a degree. However, they appear to be stalemated on the remaining five. The Senate has only passed four bills (as a minibus) so far. The other 8 are not so much deeply divisive as heavily delayed by negotiating floor amendments.
Also unresolved: which funding levels. The Senate is working from the spending levels set by the Fiscal Responsibility Act (FRA) adopted as part of the debt ceiling deal earlier this year. The House has set aggregate spending in its bills at a couple of hundred billion less.
The Ag/FDA Funding Bill Has Its Own Additional Challenges. In a sense, the Ag/FDA bill (which failed on the House floor on September 28) is a microcosm of disagreements within the Republican caucus.
The House Committee-passed version funded FDA and other programs at or near their FY 23 funding levels. Subsequently, the Chairman’s amendment would have set most programs, including FDA, at 14.15% less than the FY 23 levels.
Among other things, this creates problems for Republicans representing districts that benefit from agricultural and feeding programs. Further, there is no evidence that Republicans want to shrink the FDA by nearly $500 million–but that is what would occur if the bill became law.
All the House Republican funding bills contain problematic policy riders. The Ag/FDA bill contains a particularly problematic one, reversing a long-ago FDA action that increased access to the abortion drug mifepristone.
Upcoming Webinar on Gene Therapy with FDA’s Director of CBER, Dr. Peter Marks, December 4th at 1pm ET. Please register here!
As the Director of CBER, Dr. Marks’ leadership and vision are central to the development of gene therapies. For this webinar, Dr. Marks is going to present an overview of some of the current challenges and provide his perspective on how the field can move toward greater success and increased patient benefit.
Gene therapy, including genome editing, has the potential to be transformational in the treatment of disease, particularly for rare conditions that may have no current treatments. Despite the potential, the field has evolved slowly and often with a lot of frustration expressed by FDA, companies, and patient groups about the challenges of developing a gene therapy and bringing it to market.
This will be Dr. Marks’ second time speaking at the Alliance Webinar Series in 2023; he discussed CBER’s FY24 Budget in April. You can find a summary and transcript of his April webinar, along with the rest of the Alliance Webinar Series, on our website here.
Board members Ron Bartek (Friedreich’s Ataxia Research Alliance) and Cynthia Bens (Personalized Medicine Coalition) will be the co-moderators.
Summary and Transcript Now Available for November 13 Webinar Jim Jones, FDA’s New Deputy Commissioner for Human Foods, on Monday. Jim Jones joined the U.S. Food and Drug Administration in September 2023 as FDA’s first Deputy Commissioner for Human Foods. The webinar discussed his priorities, plans, and approach to change.
See Jim Jones’s webinar transcript here and the summary here. You can also find all the transcripts & summaries of our past Alliance webinars on our website here.
No Friday Update on November 24. Friday Update will not publish on November 24th due to the holiday. However, we will publish the following Friday, December 1st. Regardless of the publication schedule, the Alliance staff will be available to our members and media throughout Thanksgiving week.
No Friday Update on November 24. Friday Update will not publish on November 24th due to the holiday. However, we will publish the following Friday, December 1st. Regardless of the publication schedule, the Alliance staff will be available to our members and media throughout Thanksgiving week.