August Recess; User Fees Uncertain; Transcript of Dr. Woodcock Webinar

Top-Line

• House and Senate in Recess Until After Labor Day; Appropriations Bills Face Looming Deadlines.

• Action on User Fees Remains Uncertain.

• Dr. Woodcock on Consequences for FDA’s Workforce if the User Fee Impasse Continues

• Transcript of Webinar with Dr. Woodcock Now Available.

• Just Announced: September 21 Alliance Webinar on “FDA and One Health.”

This week’s Analysis and Commentary features a wide-ranging FAQ about FDA funding and resource needs.

House and Senate in Recess Until After Labor Day; Appropriations Bills Face Looming Deadlines. The House returns on Friday, August 12, to complete action on the Inflation Reduction Act of 2022. Otherwise, the House and Senate are in recess and will not conduct business until after Labor Day.

In terms of completing appropriations bills by October 1, the prospects are not bright given the few session days remaining before the end of the fiscal year. The Senate returns to session on September 6, anticipating eighteen legislative days before the end of the fiscal year. The House returns for committee work on September 6, and floor sessions beginning September 13. Altogether, the full House is in session for only eleven days in September.

FY 23 funding negotiations may continue at the staff level during August, but nothing will occur publicly until September. Even then, progress is likely to be driven by whether there is an agreement on total spending. We have heard no new reports on the progress of negotiations or even if there has been recent discussion among Congressional leaders.

It is likely, therefore, that FY 2023 funding for FDA will be provided under a Continuing Resolution, probably until after Election Day.
We agree with Alliance member Research!America, which has observed: “The fact that CRs have become the norm does not mean they should be the norm. It is dangerous to freeze our nation in time while the threat of another pandemic grows and myriad other priorities call for new thinking and quick responses.”

Action on User Fees Remains Uncertain. There has been no visible progress on user fee reauthorization—no known meetings, no hallway chats among Senators. Nonetheless, we hope those have been occurring out of sight.

Thus, our prior discussions here, here, and here are accurate, albeit we are yet another week closer to the consequences of inaction. We will be watching this closely throughout August, as will the entire FDA stakeholder community. This week’s Analysis and Commentary includes a Q&A on understanding how the impasse has come about.

Dr. Woodcock on Consequences for FDA’s Workforce If the User Fee Impasse Continues. During her webinar with the Alliance on August 4, Dr. Woodcock responded to a question about delays in reauthorizing user fees. Our take-away from her comments: for existing staff, the period of uncertainty is hard and will affect morale, despite a common understanding that user fees will be reauthorized before too long.

For those individuals being recruited, some just waiting for a signed employment letter, there is the threat of a permanent loss for the agency. Some may take their skills elsewhere. Each such loss also means the agency will need to renew its recruitment efforts.

Transcript of Webinar with Dr. Woodcock Now Available. The Alliance’s August 4 webinar with Dr. Woodcock was about knowledge management and building enterprise-wide infrastructure to support better and more efficient decision-making. The transcript is now available here and is well-worth reading.

She reminds us: Improved information infrastructure is critical to better and more efficient decision-making in the future. While weak infrastructure may be invisible and not very sexy, the future of FDA depends on the investment.

Just Announced: September 21 Alliance Webinar on “FDA and One Health.” The Alliance is pleased to announce the first of its fall webinars: September 21, at 11:30 a.m. Register here.

“One Health” is an approach to solving health problems by recognizing the interconnection of people, animals, plants, and the environment. FDA is one of many federal agencies that support this approach and encourages its use. The webinar will explain the concept in more detail and feature presentations on how FDA’s work utilizes One Health. Subsequent program announcements will include more on the speakers and agenda.