Congress in Recess; Much to Do When They Return November 12
This week’s Analysis and Commentary is entitled: “We Got the FY 25 CR Story Right, What’s Next? Part 2.”
Congress in Recess; Much To Do When They Return November 12. Here is what you need to know:
With the approval of the CR, which goes through December 20, the House and Senate are in recess until November 12. That allows 2 weeks before Thanksgiving and 3 weeks in December to resolve disagreements about FY 25 funding.
The “what comes next process” is largely baked in now (here).
The uncertainty of “what comes next substance” is the topic of this week’s Analysis and Commentary.
House Republicans will not accept a 12-bill omnibus nor any smaller minibus packages. Given limited House floor time in December, this will make it even harder to move.
Behind the scenes: The Presidential transition will be remaking agency priorities. More on the nuts and bolts of the Presidential Transitions Act can be found here.
Behind the scenes: OMB is coordinating with cabinet agencies to lay the groundwork for FY’26 budgets.
Upcoming Webinar with Jim Jones, FDA Deputy Commissioner for Human Food.
October 31st, 2:00 pm EST
Register HERE
The public—even stakeholders—may only think about FDA/HFP’s role during emergencies and crises when such events are making headlines.
The reality: emergency and crisis preparedness is a 24/7/365 responsibility and takes many forms (inadvertent adulteration; intentional adulteration; biological threats; environmental contamination).
The Alliance Webinar Series continues with Jim Jones, Deputy Commissioner for Human Foods, who will address this topic.
Impact of Port Strikes: None for Now; Potential Issues Again on January 15. While the announcement of a tentative deal between the labor union and shipping industry was welcome news last night, we still must hope a new agreement will be finalized by January 15, the new deadline.
On Monday, HHS announced recent actions–taken by HHS with FDA and the Administration for Strategic Preparedness and Response (ASPR)–to address the impact of the labor strike.
HHS advised, “immediate impacts across medicines, medical devices, and infant formula for consumers, parents, and caregivers should be limited.” Given the extensive U.S. reliance on overseas production of active pharmaceutical ingredients (API) and medical supplies, it remains to be seen how “immediate impact” and “limited” wind up affect the near-term timing of FDA-regulated imports.
As the congested supply chain unwinds, inspection delays for foods, cosmetics, and other FDA-regulated goods, along with other issues, are unknown at this time. Additional details and analysis are provided in the attached memo from OFW Law found here.
Alliance Webinar with FDA Commissioner Dr. Califf: Summary and Transcript Now Available on Alliance Website. About 200 members of the FDA stakeholder community participated. The transcript can be found here and the summary can be found here.
This event was featured across the media, including: here, here, here, and here.
FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect. FDA Commissioner Robert Califf announced on Tuesday the official implementation of FDA’s plan to reorganize with a unified Human Foods Program and new field operations office to replace the former Office of Regulatory Affairs (ORA). The FDA release is available here.
Alliance Member Benefit: In-Person Meetings with FDA Senior Leaders. We have started a series of in-person meetings with the FDA that complements our webinar series. These meetings are smaller and more informal, and only open to Alliance members. To inquire about joining the Alliance, please contact Steven.
Friday Update Returns October 18. With the House and Senate in recess until November 12 and the nation focused on the elections, we will not be publishing Friday Update next week (October 11). Friday Update will return on October 18.
Alliance staff will be available to assist Alliance members throughout this period.