“Hurry up and wait” most likely scenario for spending bills; options if Congress can’t reach agreement on spending levels.

Top-Line:

  • Appropriations bills are moving, but “hurry up and wait” is the most likely scenario.

  • Spending bills can move because of deeming resolutions.

  • Options if Congress can’t reach agreement on spending levels.

  • How long Dr. Woodcock can stay acting?

  • CDRH Director Jeff Shuren provides Alliance with valuable insights.


Appropriations Bills Moving; But “Hurry Up and Wait” The Most Likely Scenario. During the week of July 26, the House is likely to pass Ag/FDA funding as part of a minibus that combines 7 subcommittee bills. Senate Appropriations Chairman Leahy wants his committee to move three or four bills, including Agriculture/FDA, before the start of recess on August 6. The progress on bills is encouraging, but most appropriations cycles are marked by a “hurry up and wait” pattern.

We are now in the hurry up phase and there is an unknown, but potentially long wait between now and when final action will occur. Delay can be generally attributed to the difficulty of House/Senate and Republicans/Democrats reaching bicameral and bipartisan agreement on legislation. More specifically, delays can be attributed to the macro budgetary situation. There is no agreement on total spending for FY 22 or allocation between defense and non-defense funding. Multiple areas of controversy will delay more controversial subcommittee spending bills.

Spending Bills Can Move Because of Deeming Resolutions. Obviously, it is hard for Congress to rationally spend money if they have no idea how much money is available. Thus, with no agreement on total spending levels (section 302(a) of the Budget Control Act) or subcommittee allocations (section 302(b) of the BCA), it would seem likely that appropriations would be totally stalled. The only reason that is not the case is the House’s decision to pass a deeming resolution in lieu of a binding budget resolution. Using this mechanism (as it has done from time to time in the past), the House deems a set of numbers to be the correct amount, subject to later modification. That gets the process rolling.

However, deeming resolutions don’t resolve the lack of agreement on total spending. President Biden’s budget request proposes an $121 billion (8.6%) increase in base discretionary spending over FY 21 (Biden FY 22 budget request (page 62)). The House deeming resolution is a bit lower, increasing base discretionary spending by about $100 billion over FY 21 (FY 22 House Deeming Resolution). The spending levels that will be acceptable to the Senate are unknown but may be much lower based on the statements of Republican leaders. The dynamic could change, however, if Senate Majority Leader Schumer is able to achieve a budget resolution with a reconciliation instruction that would allow passage of a more comprehensive legislative package with 50 votes plus VP Harris.

What If Congress Can’t Reach Agreement on Spending Levels? Nothing prevents Congress from passing a few funding bills and sending them to the President without an agreement on overall spending. However, this is extremely unlikely. More likely is that Congress will fund the government through Continuing Resolutions if there is no FY 22 spending agreement by September 30. Other than a government shutdown (unimaginable this year), a CR is the worst case for FDA. The agency would only be able to spend at the FY 21 levels and face some restrictions on initiating new programs. If there is a CR, one key variable is how long it lasts--to the end of October, after Thanksgiving, or into next year? That provides a sense of when Congress expects to be ready for serious compromises.

How Long Can Dr. Woodcock Stay Acting? There are legal limitations on how long an individual can be acting in a Senate-confirmable role. The governing statute is the Federal Vacancies Reform Act of 1998. This limits an “acting” to 210 days (slightly under seven months). Most of us became familiar with this restriction when Dr. Sharpless served as Acting Commissioner until the law required him to be replaced or a nominee named. Using the 210-day timeline, Dr. Woodcock could only continue until mid- to late-August unless she or another individual has been nominated to the post. In that case, she would be able to remain until she or someone else is confirmed.

However, the 1998 law recognizes that even 210 days might not be sufficient during a Presidential transition. It allows an additional 90 days (above the 210) if the vacancy existed at the time of inauguration or falls vacant during the first 60 days after the inauguration. Under the 210 day plus 90-day timeline, Dr. Woodcock could continue to mid-November unless she or another individual has been nominated to the post. In that case, she would be able to remain until she or someone else is confirmed.

So, mid-November is the correct answer to “how long can Dr. Woodcock stay acting.” She can stay longer if she or someone else is nominated for the position pending Senate confirmation.

CDRH Director Jeff Shuren Provides Alliance With Valuable Insights. At this week’s webinar, Dr. Jeffrey Shuren, the Director of the FDA’s Center for Devices and Radiological Health (CDRH), provided valuable insights into the Center’s operations over the past year, and his straightforward recognition of future needs to keep CDRH at top performance. An audio copy of the program is here. We expect to have a transcript sometime next week. This Week’s Analysis and Commentary (below) reviews some of the key points from his presentation.

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Summary of: Alliance webinar with CDRH Director Dr. Jeffrey Shuren

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Summary of: Alliance webinar with Judy McMeekin, Association Commissioner for Regulatory Affairs