FY23 Appropriations; User fees; Dr. Woodcock on User Fees and Future of FDA Knowledge Management

Top-Line

• Update on FY 23 Appropriations.

• Schedule for Action on User Fees Still Uncertain.

• Dr. Woodcock on Consequences of a User Fee Impasse

• Dr. Woodcock’s Presentation Lays Out the Future of FDA Through Investment in Knowledge Management.

• Want to Know More About FDA? Alliance’s New Website Delivers www.strengthenfda.org.

This week’s Analysis and Commentary cover some highpoints in Dr. Woodcock’s presentation to the Alliance on August 4. The tape of the event is here, and Dr. Woodcock’s slides are here. A transcript will be ready next week.
 
Update on FY 23 Appropriations. The House was in recess this week. The Senate addressed a number of backlogged items and will remain in session this weekend to address reconciliation. After the weekend, both bodies will be in recess until September. Thus, little has changed since our previous three reports: July 22, July 29, and our summary of the initial Senate draft bills.  

FY 23 funding negotiations may continue at the staff level during August, but nothing will occur publicly until September. Even then, progress is dependent on 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.

Schedule for Action on User Fees Still Uncertain. There has been no visible progress on user fee reauthorization—no known meetings or hallway chats among Senators. Nonetheless, we hope those have occurred.

Thus, our prior discussions here and here are accurate, though we are one week closer to the consequences of inaction. We will be watching this issue closely throughout August, as will the entire FDA stakeholder community. In the next story below, we have Dr. Woodcock’s comments to the Alliance yesterday on our webinar on information and technology modernization.

Woodcock on Consequences of a User Fee Impasse. 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. Nonetheless, we asked a question about user fee reauthorization.

Dr. Woodcock said that the delay in the user fee program is difficult for the agency. It is affecting the morale of current staff and endangering recruitment of new staff, particularly for areas of great need such as cell and gene therapy.

She said FDA anticipates hiring up to six hundred new personnel with the user fee money, an ongoing process that cannot proceed until funding is assured. She imagines many of the agency’s potential recruits have other offers that they may accept in light of the delay and uncertainties.

Dr. Woodcock acknowledged that FDA has a short-term solution from carry-over PDUFA funding. She did not specify when those funds would run out, but her remarks are consistent with others who have estimated 5 weeks from October 1.

Our take-away: 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 other jobs and not bring their skills to the agency. Each such loss also means the agency will need to renew its recruitment efforts.
 
Dr. Woodcock’s Presentation Lays Out the Future of FDA Through Investment in Knowledge Management. Over the last 3 years, FDA has developed and issued three plans for modernization of FDA’s infrastructure. Since then, there have been multiple statements of support for these efforts: FDA has allocated part of its Budget Requests to fund this need (page 13 (here); the Alliance’s testimony to the appropriations committees has included a request for funding (House and Senate); and Congress has indicated interest in infrastructure modernization at FDA (here).

Improved information infrastructure is critical to better and more efficient decisionmaking in the future. During her webinar with the Alliance, the overriding message was weak infrastructure may be invisible and not very sexy, but the future of FDA depends on the investment.

More comments are discussed in this week’s Analysis and Commentary (below). The tape of the event is here, and Dr. Woodcock’s slides are here. A transcript will be ready next week.

Want to Know More About FDA? Alliance’s New Website Delivers at www.strengthenfda.org. On the site you can find transcripts and/or summaries of all 19 webinars that the Alliance has held since April 2021. The webinars are hour-long programs with senior FDA leadership. Whatever part of FDA you are interested in, it has been covered by one of our speakers. Go to the Alliance’s Events page here.

More broadly, the new website is content-rich, including the following: our Friday Updates, including Analysis and Commentary; discussion of FDA resources and funding, including our authoritative “How FDA Is Funded;” key budget documents—current and archival; FAQ links to useful parts of the FDA website. We continue to build the site—let us know what you would like to see there.