Advocacy at a Glance

Top-Line: Under the House reconciliation bill, FDA would gain $500 million in no-year money to support its COVID-19 activities. The Alliance issued a statement of support for these funds. The House/Senate timetable aims to have the bill signed by the President before March 14. President Biden’s budget request is likely to come sometime after that date. Alliance members are offered the opportunity to provide feedback on the Alliance’s funding request for FY 22. This week's Analysis and Commentary digs deeper into FDA and the reconciliation process.House Reconciliation Bill Would Provide FDA With $500 Million in No-Year Monies for COVID-19 Activities. On February 11, the House Energy and Commerce Committee considered Part A, the Public Health portion 'of its reconciliation bill. Section 3004 would provide $500 million in no-year monies to support FDA's COVID-19 activities. The text is in this week’s Analysis and Commentary. An amendment was offered in Committee to specify that $100 million of the total be devoted exclusively to therapeutics. This would have undercut FDA's flexibility and was defeated 26-31. The discussion starts at 5:39:45 in the Committee’s mark-up.The Alliance for a Stronger FDA supported these additional funds, stressing the importance of the FDA's role in combating the pandemic and the need for funds to cover COVID-19 activities. Alliance added that, apart from the pandemic, FDA's mission and responsibilities have grown considerably in the last year and additional base funding will be needed in FY 22. The Alliance’s statement is in this week’s Analysis and Commentary.House Aims for Reconciliation Bill to Be Signed by March 14. The House Energy and Commerce-passed bill, along with reconciliation bills from eight other House authorizing committees, are expected to be finished this week and sent to the House Budget Committee. That Committee will meet next week to combine the committee bills into a single reconciliation package. It will then be reviewed by the House Rules Committee before going to the floor. The House plans to bring the package to the floor during the week of February 22. According to House Speaker Pelosi:

We hope to have this all done by the end of February, certainly on the president’s desk in time to offset the March 14 deadline, where some unemployment benefits will expire

(more on her remarks here).The Often-Mentioned Byrd Rule Should Not Affect New FDA Funds. The Byrd Rule excludes from reconciliation any items that do not produce a change in outlays or revenues, or increase the deficit beyond the “budget window”​, i.e. the period covered by the Budget Resolution. While it is a Senate procedure, it does effectively limit what the House might include in a bill so as to avoid the invocation of the Byrd Rule (a more detailed discussion is here). FDA funding is not likely to be subject to the Byrd Rule since this funding is within the limits set by the reconciliation instruction.President Biden’s FY 22 Budget Request Likely to Be Delayed. We have been told that the Administration will not submit its budget request (even the “skinny" version) until after Reconciliation is completed, which should occur by mid-March. No timetable has been released and further delay is possible, allegedly because the incoming OMB team was not given key documents during the transition (more here).Alliance Begins Process of Formulating FY 22 “Ask”; Solicits Input from Its Members. This is going to be a difficult year for FDA to receive a significant increase in its budget. However, it is also a time (new administration, mid-pandemic, extraordinary pressures on the agency, accelerating growth in new science) in which it is essential that we lay out a bold agenda of FDA’s needs and opportunities for FY 22 and the years beyond that. Last week’s Analysis and Commentary (here) looks at some possible themes and initiatives that the Alliance may want to consider advancing for FY 22. We hope this will stimulate Alliance members to tell us what they consider the most important FDA funding priorities whether from last week’s Friday Update or derived from their own experiences and thinking. Alliance members are encouraged to send their thoughts, preferably by February 22, to Steven Grossman at the Alliance.