Shutdown Starting to Delay New FDA Reviews, Approvals

Alicia Ault

January 16, 2019

As the federal government shutdown drags on, it will become increasingly likely that the US Food and Drug Administration (FDA) will have to delay approvals of products or to decline to start reviews of new applications for approval.

Some products are already being delayed — including an immune therapy for peanut allergy.

"It is not business as usual at FDA," said FDA Commissioner Scott Gottlieb, MD, in a tweet. "Many key functions aren't getting done. But we're focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission critical functions."

Gottlieb said the agency — which, unlike the Department of Health and Human Services (HHS), has not been given its 2019 appropriations — has enough money to keep operating through the week of February 11. "This could change, but not by more than +/- a week," said Gottlieb on Twitter. "We've stretched our resources by lowering burn by basically deferring internal operating charges and shifting money to salaries."

The halt in FDA activities "is an example of how ludicrous it is that FDA is under the agriculture appropriations bill, because all of HHS is funded except the FDA," Ira Loss, senior healthcare analyst with Washington Analysis, told Medscape Medical News.

The agency is also relying on user fees — money paid by pharmaceutical, biotechnology, and medical device companies to subsidize agency product reviews — to fund operations related to approvals and review of applications.

It's not clear how many FDA staff are not working. A contingency plan drawn up by the agency indicated that of the 17,397 people employed by the FDA, 7053 (41%) would be furloughed during a shutdown.

On January 14, Gottlieb said on Twitter that the FDA would be bringing some employees back to restart inspections of high-risk foods and compounding facilities. About 400 were being recalled; of those, 150 will focus on food inspections, 100 on inspections of high-risk medical device manufacturing facilities, 70 on inspections of high-risk drug manufacturing facilities, and 90 on inspections of high-risk biological manufacturing facilities.

Products at Risk

For companies that paid user fees before the shutdown, action will continue on their products for the time being. "If the product sponsor submitted the application and paid any required fees before the lapse, FDA can use its limited carryover user fee funding to continue reviewing the application," Gottlieb said on Twitter.

But when that money runs out, even those companies won't see any FDA action on their products. And, said Gottlieb, during the shutdown, "FDA cannot accept new medical product applications that require a fee payment. We are not allowed to accept new user fees. In these cases, sponsors will need to wait until the lapse is over to submit their applications to FDA for review."

And the peanut allergy drug? Aimmune Therapeutics, Inc, submitted an application for approval of its biologic oral immunotherapy AR101 on December 21, 2018. The FDA told the company on January 14 that it would not take up review until the shutdown ends.

That's because for most blood and allergenic extract products, user fees are not paid, "so routine review activity ceased related to new products in these categories," said Gottlieb in a tweet. "FDA does not have carryover user fee funding to continue reviewing pending or accepting new applications" for products in those categories, he said.

The agency did approve cabozantinib (Cabometyx, Exelixis, Inc) for patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar, Bayer), as reported by Medscape Medical News.

Amgen's osteoporosis therapy romosozumab (Evenity) was due to be approved January 12, but, before the shutdown, the agency scheduled an advisory committee review on January 16. Loss said he expects the FDA to take quick action right after the committee meeting.

Among the other drugs due to be approved in January: Immunomedics' sacituzumab govitecan, which would be the first product approved for metastatic triple-negative breast cancer in a third-line setting; Duchesnay's ospemifene (Osphena) for moderate to severe vaginal dryness; Sumitomo Dainippon's sublingual film formulation of apomorphine for acute, intermittent treatment of hypomobility episodes in Parkinson's disease; Merck KGaA's cladribine (Mavenclad) for relapsing-remitting multiple sclerosis; Alkermes' buprenorphine+samidorphan for use as adjunctive treatment of major depressive disorder; and Samsung Bioepis' Ontruzant, a biosimilar to Roche's trastuzumab (Herceptin).

Given that the FDA approved a record number of products in 2018, the shutdown "has potential to derail a freight train," said Loss.

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