Hep C Discussion Forum

Despite FDA shutdown, Gilead still on for high-profile panels

October 1, 2013. 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 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 is due before the same panel the day before to discuss simeprevir its late-stage hep c treatment under the FDA's priority review, but the company couldn't confirm whether the review was on schedule.

http://hepatitiscnewdrugs.blogspot.co.uk/2013/10/fda-panel-review-on-for-gileads_2.html