FDA decisions could 'slow to crawl' because of government shutdown

Experts have said the ongoing government shutdown may already have delayed approval and launch of new drugs, as the FDA’s spare cash reserves dwindle with every day that the impasse continues.

The Democrat-controlled House of Representatives is refusing to sign off president Trump’s spending plans as it contains a request for $5.7 billion to build a border wall with Mexico.

This means no new funding for federal government departments, including the FDA, which cannot accept more user fees from pharma companies until the new funding legislation is signed off.

The FDA has a contingency fund of user fees set aside just for times like this and has scaled back food safety assessments – but even so its commissioner Scott Gottlieb said at the beginning of the week that it had around five weeks’ funding left.

Congress has managed to sign a bill giving all federal employees backpay for working for free while the impasse continues – but this is cold comfort for those left without income while the political deadlock continues.

https://twitter.com/SGottliebFDA/status/1085657023612542979

And pharma will feel the impact too despite Gottlieb’s efforts to minimise the impact of the shutdown.

The FDA has already delayed a review of Aimmune’s peanut allergy drug, as blood and allergy-related products are not covered by a user fee programme.

Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development told CNN that there are lots of innovative new drugs that may be delayed.

He said: “In a very grim view of this, there are lives that are going to be lost because patients won’t get access to these drugs.”

Kaitin said the delays could affect drug makers’ plans to scale up production and launch new drugs.

There will be “a formidable backlog” of applications when the shutdown ends, which will “slow everything down to a crawl for a while,” Kaitin added.

“The inability to get new drugs to the marketplace is a very significant issue for the public - and for public health,” he told CNN.

Gottlieb has already warned that reviews of generics and biosimilars will be impacted should the funding lapse continue, hindering the FDA’s plans to encourage cheaper competition for branded drugs that have gone off-patent.

The shutdown may have implications for the FDA’s ongoing drug safety monitoring work, said Dr Joshua Sharfstein, a former FDA principal deputy commissioner.

Now a professor at the Johns Hopkins Bloomberg School of Public Health, Sharfstein told CNN: “If it takes the FDA an extra month to figure out that there was a major safety problem, well then that's an extra month of a safety problem people have to endure.”

This week, the financial analysis firm S&P estimated that the shutdown, which began on 22 December, had cost the wider US economy $3.6bn by January 11.