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.

Acting FDA Commissioner Dr. Janet Woodcock to Address Alliance on April 14. For Alliance members and media: please join us for a virtual presentation by Acting FDA Commissioner Janet Woodcock on April 14, from 11:30 a.m. to 12:15 p.m. Dr. Woodcock will discuss FDA’s priorities and resource needs, as well as data modernization and other infrastructure investments that are critical to maintaining and expanding FDA’s status as the world’s regulatory “gold standard.”

To sign up, please register here. If you are not an Alliance member and want to participate, please e-mail Steven Grossman to be our guest at this special event.

Still Waiting on the President’s Budget Preview Document. As is the case in the first year of new administrations, the usual budget cycle is significantly delayed while the new team gets organized and aligns their budget requests with their priorities. In the last two instances -- 2009 and 2017 -- a budget preview (often called the “skinny” budget) is released around March and the full document in May (as opposed to the more usual second week of February). The White House had suggested the preview would be released this week but had not done so as of Friday morning. When it becomes available, we will circulate our analysis to everyone on the Friday Update mailing list.

The Biden team stresses that the delay is driven in part by lack of cooperation from the prior administration. Contributing factors might also include the White House’s focus passage on COVID relief legislation and preparation of an infrastructure package, along with focus on executive appointments and confirmation hearings. During the immediate build-up to the “preview” document, officials stress that the coming document will be thin, even by the standards of 2017. There are likely to be increases and decreases allocated, and some program priorities described, but it is more likely to be like a long letter rather than a formal budget submission. If this is the case, it remains unclear how much it will tell us about the administration’s plans for FDA.

COVID-19 Testing Program Planned for FDA Employees. According to Politico, FDA signed a one-year contract with LabCorp to make voluntary COVID-19 testing available to FDA employees and contractors. This should facilitate the eventual return of activity to White Oak and other FDA facilities and support required in-person work such as onsite inspections. This program should be considered a necessary, but not sufficient, condition of FDA employees returning to their worksites. We assume other supportive programs will be in place before any significant part of the workforce is likely to be working in their offices and laboratories.

FDA Voices: Insights From the Agency. FDA frequently publishes blog-type columns and posts them on its FDA Voices site (here). It is a valuable source of information about agency actions and perspectives. During March, there were five columns: Rare Disease Day 2021: FDA Shows Sustained Support of Rare Disease Product Development During the Public Health Emergency (here), FDA’s Data Modernization Action Plan: Putting Data to Work for Public Health (here), FDA’s Partnership with Mexico’s Regulators Strengthens Food Safety Protections (here), FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic (here), and Accelerating Medical Device Innovation with Regulatory Science Tools (here).

When Will an FDA Commissioner be Nominated? Nearly every recent conversation about FDA either begins or ends with, “What have you heard about the nomination of a new Commissioner?” More than two weeks ago, Alliance President Ronald Bartek wrote to newly-confirmed HHS Secretary Xavier Becerra stating,

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. 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.

This week’s Analysis and Commentary examines the current situation.