FDA woes under US govt shut down

10 January 2019
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Now into the third week of the virtual US government shut down due to Democrats refusing to agree budget requests (notably building a wall on the Mexico/America border), government activities at various agencies, including the US Food and Drug Administration, are feeling the heat.

Programs responsible for approving medicines and medical devices are strapped for money as the government shutdown drags on. FDA Commissioner Scott Gottlieb said on Tuesday at the JP Morgan Conference, that at the current burn rates, user fees will run out of funding in a month's time. With the government shut down, the FDA cannot accept any new 2019 user fees because an appropriations bill for fiscal year 2019 has not been passed.

The agency is using carryover funding for now, but it doesn't look like that will last for very long. On Tuesday, Dr Gottlieb tweeted the FDA is prioritizing safety surveillance rather than pre-market drug reviews with its available funds, commented Jacob Bell on BioPharma Dive.

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