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Advocacy at a Glance

September 25, 2020

Top-Line: FDA will start FY 21 with funding under a Continuing Resolution (CR), which limits its ability to start new programs and makes it harder for the agency to plan for its program and personnel needs for the year. Alliance members and media should be sure to sign up for our October 16 webinar with CDER leadership. This week’s Analysis and Commentary discusses the basics of FDA funding.

Reminder to Media: Friday Update is on-the-record. Further, we are always available to both our members and media to answer additional questions.

Dr. Cavazzoni and Dr. Stein to Address Alliance Members and Media on October 16. We are honored that Acting CDER Director Patrizia Cavazzoni, MD and Director of the Office of New Drugs Peter Stein, MD have accepted our invitation to speak at a special Alliance webinar, scheduled for October 16 from 9:30-10:30 AM. To sign-up to participate, please contact Reed Diskey. The event is limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman.

FDA Will Begin Fiscal Year 2021 With CR Funding. For a number of reasons — some substantive, some political — it has proven impossible for Congress to pass Fiscal Year (FY) 21 appropriations bills before Election Day. Over the next few days, following House approval this past Tuesday, the Senate is expecting to pass a Continuing Resolution that will extend government funding through December 11. It is possible that all or some appropriations bills may pass before December. It is also possible that the Continuing Resolution might be extended through mid-February or the end of March. In this regard, the strategy of both parties will depend on the outcome of the election.

The consequences of a CR for FDA are many, even though they may be temporary. FDA will need to carry out its programs using the FY 20 (prior year) funding levels, without the increased monies proposed for FY 21 by the House. Further, FDA would be limited in its ability to start new initiatives (variously defined) for as long as it is on CR funding. Last (but hardly least), CRs create uncertainty, which makes program and personnel planning difficult.

Two Other FDA-Related Provisions Included in the CR. The primary purpose of a CR is to extend government funding at the prior year’s level until a specified date. In addition, CRs usually include language to extend expiring programs that Congress intends to reauthorize. Otherwise, the programs would not receive funding under the CR. Often, there are other “anomalies” that need to be fixed so that the CR does not have unintended consequences.

In the case of FDA, the CR includes language to appropriate the user fees to be collected under the new Over-the-Counter (OTC) monograph legislation enacted earlier this year. Otherwise, the program could not start on its intended date of October 1. The other FDA provision extends the Pediatric Priority Review Voucher (PRV) program to December 11. Otherwise, these orphan drug incentives would have expired on September 30. This allows Congress to adopt (or not) legislation that has been advanced that would extend the program for several more years.

Basics of FDA Funding. The Alliance serves as a primary source of information about FDA funding and the agency’s resource needs. We respond to inquiries from Congress, the media, Alliance members, and the entire FDA stakeholder community. Our outreach includes our webinar series with FDA officials and the Alliance’s Friday Update, which contains news, analysis and commentary about FDA’s budget. Later this year, we expect to repeat our popular webinar “FDA Appropriations 101.” In that spirit, this week’s Analysis and Commentary describes the basics of FDA funding. If you have questions about FDA’s appropriated resources, please direct them our way.

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