FDA could furlough 40% of employees, slow drug reviews in partial shutdown

A lapse of federal funding would mean a partial shutdown at FDA with the potential to slow approvals and advisory committee meetings stretching beyond the length of the impasse.

While negotiations in Washington continue, the possibility for either a short- or long-term budget fix before Friday’s midnight deadline is dwindling.

Russell Fortney, acting chief of CDER’s compounding and pharmacy practices branch, told BioCentury much of CDER is funded by user fees, and leftover user fee money will be spent to maintain current advisory committee activities. At least three drugs are slated for panel meetings in January: Feburic febuxostat from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) on Jan. 11 for hyperuricemia caused by chemotherapy; Evenity romosozumab from Amgen Inc. (NASDAQ:AMGN) on Jan. 16 for osteoporosis; and Zynquista sotagliflozin from Sanofi (Euronext:SAN; NYSE:SNY) and Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) on Jan. 17 as an add-on to insulin therapy in Type I diabetes.

But during a 16-day government shutdown in 2013, resource constraints forced the cancellation of two advisory committees for pharmaceutical science and clinical pharmacology and postponement of one for cellular, tissue and gene therapies. All had been scheduled for after the actual shutdown’s end.

During the partial government shutdown in January, FDA said it would not accept user fees during the funding lapse or accept regulatory submissions such as NDAs that require a fee payment (see “Government Shutdown Could Hobble FDA”).

NDAs and BLAs were not accepted after funding lapsed in 2013, unless fees had already been paid. Alliance for a Stronger FDA said that while reviews are expected to continue in the event of a partial shutdown, it is possible the agency may miss target dates.

“While reviews continue, there is a risk that agency time frames may slip. It is possible that a product review could require some activity or input unavailable in the absence of appropriated resources,” the advocacy group said.

A spokesperson for the CDER’s office of management expected prescription drug user fee activities to continue normal operations on Dec. 26.

At least one product has a PDUFA date before the end of December: Sprycel dasatinib from Bristol-Myers Squibb Co. (NYSE:BMY) for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) on Dec. 29.

A U.S. Department of Health and Human Services contingency plan released Friday predicted the furlough of 7,053 FDA staffers, 41% of the agency’s workforce. As of FY17, the most recent numbers available, user fees account for about three quarters of drug review funding; positions supported by user fees would not be affected by the furloughs.

A FY19 bill funding NIH and CMS has been enacted, so these agencies would not be affected by a shutdown.

https://www.marketscreener.com/TAKEDA-PHARMACEUTICAL-CO-6491073/news/FDA-could-furlough-40-of-employees-slow-drug-reviews-under-partial-shutdown-27794312/