Congress in Recess; Reagan-Udall Review testimony; and Digital Health and Cyber Security Webinar

Congress in Recess until Mid-November – When Will Congress Act on Appropriations?

• User Fees Extended; Other Provisions Wait for Negotiations in Nov/Dec.

• Alliance Participates in Reagan-Udall Review of Human Foods Programs.

• Alliance: Food Safety Needs Resources, Personnel, and Technology.

• Upcoming Alliance Webinar: October 20 at 1:30 p.m. “Digital Health and Cyber Security" with Dr. Suzanne Schwartz, Directors of CDRH’s Office of Strategic Partnerships & Technology Innovation (OST).

This week'sAnalysis and Commentarycovers the Alliance's Executive Director Steven Grossman's testimony to the Reagan-Udall Foundation's Independent Panel of Experts on the resource needs of the FDA's food programs.

Congress in Recess until Mid-November – When Will Congress Act on Appropriations? With the completion of the Continuing Resolution (CR), which funds operations of the federal government through December 16, the House and Senate are in recess until mid-November. Based on current legislative calendars, which are subject to change, the House returns on November 14 for 17 days, with adjournment targeted for December 15. The Senate also returns for legislative business on November 14, with 23 session days scheduled before the planned adjournment on December 21.

With respect to appropriations, Senate Appropriations Chairman Patrick Leahy (D-VT) and Ranking Member Richard Shelby (R-AL), both of whom are leaving the Senate at the end of the 117thCongress, indicate they would prefer to complete action on the FY 2023 appropriation bills before the end of this year. While House Appropriations Chairwoman Rosa DeLauro (D-CT) is of a similar mind, many Republicans in the House and Senate are calling for extending the CR until some time in the 118thCongress when, with a change in majorities, they would be in a better position to rewrite spending bills to reflect more of their priorities.

User Fees Extended; Other Provisions Wait for Negotiations in Nov/Dec.FDA user fees were extended for five years as part of the CR, but no policy action beyond those renewals was included. House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) during House debate on the CR said he has secured commitments from Senators Murray and Burr, as well as Ranking Member Rodgers, to continue working to finalize a package of FDA reforms before this Continuing Resolution expires in December. Ranking Member Cathy McMorris Rodgers (R-WA) said she remains committed to working on these priorities before the end of this Congress. Senate HELP Committee Chairwoman Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) in a joint statement said:“As part of our agreement, we and our House counterparts are committed to continuing that work, and including strong, bipartisan legislation in a robust end of year package.”

Alliance Participates in Reagan-Udall Review of Human Foods Programs. Last Friday, September 30, 2022, the Alliance for a Stronger FDA’s Executive Director Steven Grossman participated in the Reagan-Udall Foundation’s Panel for the Independent Experts reviewing the FDA’s human foods program. Steven moderated the panel on FDA’s resources with Jessica Schulken, Maureen Holohan, Carolyn Brickey, Alliance Board Member Thomas Gremillion, and Dr. Donna Garren. Several other Alliance members participated over the two days of presentations as well, both as experts and moderators.

Commissioner Califf asked the Reagan-Udall Foundation to provide a comprehensive review and set of recommendations to improve FDA’s human food safety program. Over the two-day hearing, the panelists heard from experts on nutrition initiatives, food safety, intra-federal relations, federal-state relationships, and how to position the FDA for the future.

The panel will continue receiving public input through October 7 ahead via an online portal and will submit recommendations and observations to the FDA in December. Recordings of Panel Presentations will become available through the Reagan-Udall Foundation website through mid-October.

Alliance: Food Safety Needs Resources, Personnel, and Technology. In the Alliance's testimony before the Reagan-Udall Foundation, Steven Grossman testified:

“When a complex regulatory system is under-resourced—as is the case with human food safety at FDA--you get what you get: mostly good, but very vulnerable. Properly resourcing the food safety components of FDA would allow the agency to develop and maintain a system that is intentionally excellent. Why would anyone want anything less?”

The Alliance was very grateful to present its 5-minute testimony before the panel on the budgetary issues facing the food safety program. “More resources will not solve all the problems,” Steven said. “However, no set of solutions can be successfully implemented without a larger budget, more personnel, and improved technology.”

The full testimony can be viewed here.

October 20 at 1:30 p.m. - “Digital Health and Cyber Security" with Dr. Suzanne Schwartz, Directors of CDRH’s Office of Strategic Partnerships & Technology Innovation (OST). REGISTER HERE.

Why Register to Hear Dr. Schwartz? CDRH’s Office of Strategic Partnerships and Technology Innovation provides leadership for all scientific collaborative and emerging technology-related activities at the Center. The breadth is considerable, including emergency preparedness, cybersecurity, digital health, creating a resilient supply chain, woman’s health, and regulatory science. Over the course of an hour, she will talk about her goals, priorities, and upcoming plans and provide a more personal view of her role and responsibilities