Alliance Completes Second Round of Hill Days with Senate Focus
This week’s Analysis and Commentary answers questions on the debt limit, FY 24 appropriations, and spending cuts and how those relate to the House and Senate meetings that the Alliance has held over the last two weeks.
Schedule for FY24 Appropriation Cycle Begins to Emerge. Multiple outlets report that the first wave of House Appropriation Subcommittee markups will commence on May 17 and 18 with full committee markups to take place the following week. Your Friday Update predicted this scenario (here and here) in recent editions. Though details have not yet been posted on the Committee website, you can read Chairwoman Granger’s letter here.
Five bills are expected in the first tranche including Defense, Energy-Water, Homeland Security, MilCon/VA, and Legislative Branch. If, as expected, Ag/FDA is not in the first tranche, then it is likely to be in a second set of bills planned for mark-up on June 7 and 8.
Alliance Completes Second Round of Hill Days with Senate Focus. With great help from dedicated members (THANK YOU!), the Alliance completed nearly 25 virtual meetings with Senate staff this week. As in our House meetings last week we focussed on key members of the Appropriations and authorizing committees for the FDA.
While the road ahead is unclear, we feel confident our message was well delivered. Unprompted, we fielded responses like “great presentation”, “eye-opener”, “great to see an unusual alliance”, and “we appreciate the hard work of the FDA”. These reactions are important as discussed in this week’s Analysis and Commentary.
FDA Science Forum 2023 Announced. As announced by FDA, the public workshop entitled “FDA Science Forum 2023” will be held on June 13 and 14. The workshop is intended to inform the public about the breadth of research underway at the Agency, and to show how cutting-edge science informs FDA’s regulatory decision-making to protect and promote public health.
The theme for the 2023 FDA Science Forum, “Advancing Regulatory Science Through Innovation,” will highlight areas of FDA research, including: (1) improving clinical and postmarket evaluation, (2) tools to effectively use big data, (3) product development tools and manufacturing, and (4) medical countermeasures (MCMs), infectious disease and pathogen reduction technologies.
The public workshop will be held on June 13, 2023 (Day 1), from 9 a.m. to 3:30 p.m. Eastern Time, and June 14, 2023 (Day 2), from 9 a.m. to 2 p.m. Eastern Time. To register for the event, click here. For further information, click here.
UPCOMING: Alliance Webinar with FDA Chief of Staff Julie Tierney Webinar on FDA Staffing. The Alliance’s webinars on the FDA’s FY 24 budget request had one common theme—all five Center Directors and the Director of ORA addressed issues surrounding vacancies, hiring incentives, recruitment, retention, training, and the professional backgrounds most needed by the agency. There was also interest in the “back to campus” policy and the ramp-up cycles for new employees to become proficient.
To provide a comprehensive overview of these issues, Julie Tierney, the FDA’s Chief of Staff, will be the featured speaker on an Alliance webinar scheduled for Monday, June 5, at 1 p.m. Sign up here.
Alliance members are encouraged to submit questions in advance to Steven Grossman so that we can be sure the program is responsive to the information that stakeholders most want to know.
Soon to Be Scheduled: Webinar Update on the Oncology Center of Excellence. Amazing advances are on the horizon for cancer care, such as flash radiation treatments (here). It is 18 months since the Alliance held a webinar on the FDA’s Oncology Center of Excellence (transcript here).
In a return appearance scheduled for mid-to-late June, Dr. Paul Kluetz, Deputy Director of the OCE, will update us on the OCE–structure, resources, and advances. A registration link will be posted as soon as we have worked out the date and time.