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PDUFA Funds Likely to Run Out in February

Posted 23 January 2019 | By Zachary Brennan 

PDUFA Funds Likely to Run Out in February

As the Senate preps for votes to reopen the government on Thursday, the situation at the US Food and Drug Administration (FDA) is becoming increasingly strained.

At an all-staff meeting for employees of the centers for drugs and biologics on Tuesday, Commissioner Scott Gottlieb announced that Prescription Drug User Fee Act (PDUFA) funding is likely to run out by 17 February (he’d previously said it would run out by the beginning of February), although the agency may find a way to stretch the funds to the end of the month.

That cut-off date could put the approval decisions of several drugs in jeopardy, including J&J’s major depressive disorder drug esketamine, which has a PDUFA date of 4 March. But J&J said Tuesday in its earnings call that the date has not changed and it's following the situation closely.

Sage Therapeutics’ Zulresso (brexanolone), which has a PDUFA date of 19 March, also may be backlogged if PDUFA funds at the agency run out.

The threats to new medicines coincide with other patient safety concerns raised by dozens of organizations that wrote to President Donald Trump and congressional leaders Tuesday.  

“On behalf of patients across this country, we are greatly concerned that the agency is currently not fully funded, and thousands of vital FDA employees are not working or able to operate at full capacity,” they wrote.

Meanwhile, Gottlieb also told FDA staffers Tuesday that drug compounding user fees have run out, 70% of FDA’s Office of Regulatory Affairs is now furloughed and generic drug user fees still have a few months left.

“We'll be continuing high-risk inspections of compounding facilities,” Gottlieb clarified. “It will be excepted work, meaning our dedicated inspectors will not be paid for these assignments during the funding lapse, but compounding inspection work continues.”

Last week, Gottlieb also said hundreds of other inspectors would come back on board to cover high-risk medical device, pharmaceutical, biologic and food inspections.

He also cautioned about the release of future guidances, as they are supported by carryover user fees.

“These were guidance documents that, generally, were in very advanced stages of development, and close to being releasing before the lapse in appropriations. It's the case that new guidance development is being affected by the lapse,” he added.

But the halting of various functions within FDA because of a lack of funds is not coinciding with a lack of concern from senior leadership. On Thursday afternoon, FDA leaders will meet with furloughed staffers to provide administrative information on the shutdown to help them manage being furloughed.
 

Tags: FDA, PDUFA, shutdown

Categories: Regulatory News

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