FDA decisions likely to slow to a crawl due to government shutdown

21 January 2019

Experts have stated that the ongoing government shutdown may already have delayed approval and launch of new drugs, as the Federal Drugs Agency'a (FDA) spare cash reserves diminish with every day that the impasse continues.

The shutdown has arisen because 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 that there is no new funding for federal government departments, including the FDA. In addition, the organisation 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 which have been reserved for situations such as the current shutdown. However, this is rapidly dwindling despite also cutting back on other activities such as food safety assessments.

The FDA has already delayed a review of a peanut allergy drug and allergy-related products are not covered by a user fee programme. In addition, experts have wanted that a number of new drugs that are highly likely to be delayed in getting to market, potentially putting patients’ lives at risk.

FDA commissioner Scott Gottlieb has already warned that reviews of generics and biosimilars will be impacted if the funding lapse continues, hindering the FDA’s plans to encourage cheaper competition for branded drugs that have gone off-patent. The shutdown may have also implications for the FDA’s ongoing drug safety monitoring work.

Last week, the financial analysis company S&P estimated that the shutdown, which began on 22 December, had already cost the wider US economy $3.6bn by 11 January. It’s hard to predict what will happen next but the clock is most definitely ticking.



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