Harris to Chair House Ag/FDA Subcommittee
Top-line:
State of the Union (SOTU) and the Beginning of a Timeframe for the FY 24 Appropriations Cycle.
Representative Andy Harris to Chair House Ag/FDA Appropriations Subcommittee.
February 15 at 2 p.m. Webinar on Diagnostics with Elizabeth Hillebrenner, CDRH Associate Director for Scientific and Regulatory Programs. Register here.
Alliance FY 24 Budget Webinars Coming in March and April.What is the Latest in FDA Policy, Legislation, and International Affairs?
Reminder to Alliance Members.
This week's Analysis and Commentary (below) summarizes the Alliance's January 13, 2023 webinar with Andi Fristedt, FDA's Deputy Commissioner for Policy, Legislation and International Affairs.
State of the Union (SOTU) and the Beginning of a Timeframe for the FY 24 Appropriations Cycle. The Congress’ extended organizing period has pushed the President’s State of the Union (SOTU) address to February 7.
At the Alliance’s January 13 webinar, FDA Deputy Commissioner Andi Fristedt suggested that the President’s FY 24 budget will not be ready for release during the customary first or second week of February. She hinted late February or early March as the most likely timeframe. This is consistent with information from other sources.
Even 4 or 5 weeks late (early March instead of early February) will probably not alter the default Congressional appropriations schedule. That is, departments and agencies can expect to testify on their budgets starting in late March through early May. Subcommittee mark-ups might begin toward the end of April through June. The House might consider bills on the floor as early as late June and July. The Senate could act in July, but more likely September.
Most years, the appropriations schedule described above runs into budgetary and political issues and is never as smooth as suggested. Particularly this year, we expect macro budgetary issues to drive scheduling as Congress considers possible rollbacks in total spending, a fight over defense and non-defense spending, and a debt limit fight that encompasses both.
Representative Andy Harris to Chair House Ag/FDA Appropriations Subcommittee. The subcommittee chairs on the House Appropriations Committee have been announced. Republican Andy Harris of Maryland will chair the House Ag/FDA Subcommittee.
In a statement, Representative Harris said: “I am excited for the opportunity to work with the FDA to ensure the safety and efficacy of the latest developments in drug and medical device research, as well as food safety.”
February 15 at 2 p.m. Webinar on Diagnostics with Elizabeth Hillebrenner, CDRH Associate Director for Scientific and Regulatory Programs. The diagnostics market has evolved in size and complexity but many diagnostic tests that patients receive do not undergo FDA review and clearance.
This educational webinar is intended to highlight FDA’s role in the current regulatory landscape for diagnostics and underscore why regulation in the diagnostics space remains so complicated. Attempts to pass legislation clarifying FDA’s statutory authority with respect to diagnostics fell short in the last session of Congress and the FDA has said it may consider using its rulemaking authority in this area. The webinar will also cover topics such as increased staffing and resource needs for the agency if it is required to oversee a larger number of diagnostics in the future.
The webinar will be at 2 p.m. on February 15. Register here.
Alliance FY 24 Budget Webinars Coming in March and April. After the February webinar, the Alliance will have a series of webinars in late March and early April on the President’s FY 24 budget request. There will be six programs in total—each focusing on a specific Center or the Office of Regulatory Affairs. Date/time and further program details should be announced soon.
Reminder to Alliance Members. On Monday, January 16, Alliance members received an online link to register approval/disapproval/abstention for a new slate of directors whose term will run through 2024. They will join others on the board whose terms run through 2023.
If you have not already responded, please follow the link in that email for additional information and to register your organization’s position. We have a busy year ahead and your board members provide incredibly valuable insights and service.