FDA says it's running out of funds; to restart food inspections despite shutdown

FDA says it’s running out of funds; to restart food inspections despite shutdown

By PharmaCompass

2019-01-17

Impressions: 151 Article

In the US, the ongoing government shutdown has turned out to be the longest in history and President Trump has said it could stretch on for “months or even years.”

However, the US Food and Drug Administration (FDA) has resumed food safety inspections at facilities that handle riskier products such as fresh-cut produce, seafood and soft cheeses.

FDA Commissioner Scott Gottlieb said last week he would try to recall about 10 percent of food inspectors. Gottlieb said hundreds of furloughed employees have agreed to come back and restart inspections that had stopped with the federal government shutdown that began on December 22.

Though FDA can retain more than half of its workforce thanks to application fees paid by drug and device makers, Gottlieb has cautioned that the agency has only about three weeks’ worth of funding to draw down. The agency can’t accept any new fees during the shutdown.

In a tweet, Gottlieb said: “We’ve stretched carryover drug user fees to get a longer runway should the shutdown continue, by for example sharply reducing any overhead charges to CDER/CBER. The slower burn rate gives us about five weeks left as of this week. These numbers could change.”

“We’re shifting operating dollars to payroll dollars in order to maximize our runway and preserve program functions,” he added.

The government shutdown, therefore, threatens to jeopardize highly anticipated new drugs from Janssen, Sanofi, and Novartis for depression, diabetes and multiple sclerosis, as also other potential new therapies.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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