Provided by FierceBiotech
October 1, 2013 | By Damian Garde
As of today, the FDA has been virtually halved, and while the mandatory furloughs spelled out by a government shutdown may imperil some of the agency's duties, it appears that drug approvals and reviews will go unmarred.
Yesterday, an FDA spokesperson told FierceBiotech that, because agency advisory panels are funded by industry-paid user fees and not tax appropriations, "generally speaking, these meetings would continue in some way" after a shutdown. That's not exactly a clear-cut guarantee, and, unsurprisingly, there's no one around to clarify this morning. That said, the drugmakers with products on the line are optimistic their timelines will stay intact.
Gilead ($GILD) has an Oct. 25 date to with the Antiviral Drugs Advisory Committee to discuss sofosbuvir, a hep C treatment it hopes to get approved this year, and that meeting hasn't been canceled, the company told us. Johnson & Johnson ($JNJ) is due before the same panel the day before to discuss simeprevir, its late-stage hepatitis C treatment under the FDA's priority review, but the company couldn't confirm whether the review was on schedule.
Amarin Pharmaceuticals ($AMRN) is gearing up for a weighty Oct. 16 panel vote on whether to approve Vascepa paired with statins to reduce cholesterol, and the company said it hasn't been informed of any delays. On the device side, Medtronic ($MDT) has an Oct. 8 date with the Circulatory System Devices Panel, asking for an expanded indication for its fleet of pacemakers and implanted defibrillators, and the company said that meeting is still on.
The FDA is down 6,620 employees this morning, losing about 45% of its staff to furloughs, and the agency has suspended the "majority" of its internal lab research, according to a Department of Health and Human Services briefing. Also on hold is the FDA's usual stream of guidances and new regulations, as government agencies have been instructed to publish only documents that support activities related to "imminent threats to the safety of human life or protection of property."
It remains anyone's guess how long the shutdown will last. The House and Senate have thus far traded party-line votes on sure-to-be-rejected budget bills, with Republicans pushing to include provisions that would delay aspects of the Affordable Care Act while Democrats insist on a stripped-down resolution to reopen the government.
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