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Getting a Firm Grasp on the Budget Preview

April 9, 2021

When the full President’s budget request comes out (early February most years; sometime in May in 2017 and 2021), there is always a scramble to get accurate information out quickly. After years of doing this, the Alliance has become good at it–largely by knowing to always look first for the All-Purpose Table and the Summary of Changes and compare them to the Budget Authority (BA) tables. … READ MORE …

Advocacy at a Glance

April 9, 2021

Top-line: Acting FDA Commissioner Dr. Janet Woodcock will address the Alliance on April 14. A preview of President Biden’s Budget Request will be released on April 9. Reconciliation on the President’s Infrastructure Request will have an unknown impact on appropriations. This week’s Analysis and Commentary describes what we might learn from a limited budget release.

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Legal Limitations on Appointment of New FDA Commissioner

April 3, 2021

Nearly every recent conversation about FDA either begins or ends with, “What have you heard about the nomination of a new Commissioner?” In this regard, we have heard bits of speculation, but nothing that purports to be anything more than that. President Biden and Secretary Becerra’s plans are as opaque to us as they appear to be to the rest of the stakeholder community. 
 
Historically, FDA has been blessed with strong and talented acting commissioners — as it is now. Given the widespread respect for Dr. Woodcock, there are some in the stakeholder community who would be fine if the current situation were to continue indefinitely. However, there are two reasons why that cannot happen.
 
First, no matter how capable and worthy the Acting Commissioner, that person cannot fulfill indefinitely one of the most important responsibilities of the position. Only a Presidentially-nominated and Senate-confirmed FDA Commissioner can stand behind long-term commitments to the President, the Secretary, Congress, FDA staff, and the American people. Inherently, an official in an acting capacity cannot do that.
 
That does not preclude an individual from serving in an acting capacity and then being nominated for the post. In such a case, it can reasonably be expected that their leadership would be stronger once confirmation occurs.
 
Second, 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 (here). 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. This was an issue 15 years ago during the time that Dr. Lester Crawford was acting. The GAO violation letter is here.
 
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 fell 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.
 
It seems very unlikely that the administration would let that amount of time go by without nominating a commissioner. From the Alliance’s standpoint — we urge speedy nomination and confirmation but back no specific candidates. It would be most regrettable for this position to continue to remain vacant. FDA’s work is too important, every day and for all Americans, for much additional time to pass without Dr. Woodcock or some other candidate being nominated. 
 
For those interested in a longer discussion of the Federal Vacancies Reform Act and its implications for the new administration, there is an excellent explanation from the American Constitution Society (here).

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

Advocacy at a Glance

April 3, 2021

Top-Line: Acting FDA Commissioner Dr. Janet Woodcock will address the Alliance on April 14. The President’s FY 22 Budget Preview has not yet been released. FDA employees to receive voluntary COVID-19 testing. FDA Voices offers multiple columns. We are still waiting for an FDA Commissioner to be nominated. In this week’s Analysis and Commentary we review the current situation. … READ MORE …

Alliance Working Hard on BA Appropriation for FY 22

March 27, 2021

The annual appropriations cycle is a multi-step process that starts with the President’s Budget Request (usually during the second week of February) and usually ends later in the same calendar year with the passage of funding bills by Congress and their signature by the President. … READ MORE …

Advocacy at a Glance

March 27, 2021

Top-Line: OMB will provide a preview of the President’s FY 22 Budget Request next week. CBER releases its five-year strategic plan. This week’s Analysis and Commentary explores how the Alliance and its members can demonstrate support for the agency to Congress. Principal Deputy Commissioner Abernethy will leave the agency and her contributions are described. FDA Voices provides insight into FDA’s approach to inspections during the pandemic. … READ MORE …

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.

Advocacy at a Glance

March 19, 2021

Top-Line: Secretary Becerra was confirmed this week and faces a large and pressing set of responsibilities. The Alliance wrote to the Secretary, congratulating him on his confirmation and urging him to swiftly press for nomination and confirmation of a candidate for permanent FDA Commissioner. … READ MORE …