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Shutdown and the FDA

Stat News reports that if the partial government shutdown in the US continues, it may soon affect the ability of the Food and Drug Administration to review new drugs.

The shutdown began 24 days ago when President Donald Trump and Congressional lawmakers were unable to come to an agreement over funding the government, particular as Trump has insisted that the funding measure include more than $5 billion for a border wall. It is unclear how much longer the government may remain closed, as Trump has said the shutdown could last months or years.

While the FDA has been able to continue some of its work during the shutdown because of the agency's reliance on user fees, Commissioner Scott Gottlieb has said that it only has about three more weeks' worth of funding left, according to Stat News. It adds that FDA is unable to collect additional user fees during the shutdown.

This means, Stat News says, that FDA will soon be unable to meet review deadlines for some new drug applications. It notes that drug makers like Janssen, Sanofi, and Novartis are expecting decisions in March, after Gottlieb says the agency will likely run out of funds. This, it adds, could have follow-on effects even if the government re-opens, as it'll create a backlog regulators will have to work through.