Skip to content

Two Topical Political Issues

March 19, 2021

Q: How did the Alliance describe its letter to Secretary Becerra about the need for a permanent FDA Commissioner?

A: “Today, the Alliance for a Stronger FDA congratulated Secretary Becerra on his confirmation and urged him to swiftly nominate and seek prompt confirmation of a permanent Commissioner to lead the FDA. The Alliance praised FDA’s current leadership, while stressing the need for a confirmed Commissioner who can stand behind long-term commitments to the President, the Secretary, Congress, and the American people. In similar situations in 2009 and 2017, the Alliance urged President Obama and President Trump to make swift appointments of a permanent Commissioner. The Alliance has never endorsed any specific candidates to run the agency.”

“‘FDA’s leadership has never been more essential than today, as we face the challenges posed by COVID-19 as well as constantly accelerating developments in science, technology, innovation, and social trends,” said Ronald J. Bartek, Alliance President and President of theFriedreich’s Ataxia Research Alliance. “FDA needs a Senate-confirmed leader during these difficult and rapidly changing times. Accordingly, the Alliance for a Stronger FDA urges the new administration and Secretary Becerra to nominate an FDA Commissioner swiftly.’”

Q: What are the steps and timing of the regular appropriations cycle and how is the FY 22 appropriations process going to be different?

A: In most years, the President delivers his/her State of the Union in late January and then OMB releases the President’s Budget Request document during the first or second week of February. The portion of the request document for each agency — Justification of Estimates for Appropriations Committees — is usually referred to as the Congressional Justification (CJ).

The CJ for the FDA provides a complete breakdown of recommended funding levels and a full description of any new initiatives. Typically, FDA’s CJ is more than 300 pages long.

After the President’s request is released, the House and Senate Appropriations Committees hold agency hearings, usually in March and early April. In the House, subcommittee markups usually start at the end of April, followed by full committee markups. Leadership tries to bring all of the bills to the House floor in June. The Senate usually does subcommittee markups about a month after the House, with the goal of bringing bills to the floor in July. These dates can vary widely from year to year and are often slowed down by negotiations over total spending levels and the allocation to each subcommittee.

The front end of this schedule is always different in the first year of a new administration. Prior to the Inauguration, OMB and the agencies are still working on a budget request based on what the outgoing President wants. Even when numbers are fully shared with the transition teams (which did not occur this year), compiling a full document of numbers and priorities for a new President cannot be done quickly. New administrations tend to submit a so-called “skinny budget” usually by March and a full budget in May.

Appropriators want to continue with their normal schedule, which is keyed to the October 1 start of the new fiscal year. However, they must also adjust to the difficulty of advancing too far in their own work without the benefit of information contained in the President’s request. As this develops for FY 22 — as an overall process and with specific regard to FDA fundingthese Friday Updates will be here to provide the information you need.

Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.

Comments are closed.