Wednesday, October 2, 2013

FDA Panel Review On For Gilead's Sofosbuvir Despite Government Shutdown

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

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.

Source FierceBiotech

Shutdown dims lights at FDA, NIH and CDC

The government shutdown that went into effect at midnight put 800,000 government employees out of work for the duration. The fallout includes 40,513 Health and Human Services employees, or 52% of the department's staff, while 48% will continue to come in and be paid.

At the FDA, this means 45% of the agency's staff has been sent home. Assistant commissioner of media affairs Steven Immergut emailed MM&M that of the 55% of staff who are allowed to work, 74% of them are funded by user fees. The shutdown means the FDA will not be able to perform tasks including routine inspections, some compliance activities, and “the majority of the laboratory research necessary to inform public health decision-making.”

Of the media affairs staff, Immergut was the only one of three media affairs specialists allowed to show. Colleagues Heidi Rebello and Erica Jefferson's out-of-office messages noted, “I am out of the office on furlough and cannot respond to your email.”

The Street's Adam Feuerstein noted last week that the shutdown could mean Amarin (vascepta), Johnson & Johnson (simeprevir) and Gilead (sofosbuvir) see their advisory review committee days evaporate.

Also as part of the shutdown, the National Institutes of Health will not review grant applications or begin new treatment protocols, and will cease other functions. The Centers for Disease Control and Prevention is also scaling back, and will not be able to provide state and local support for infectious disease surveillance or the annual seasonal influenza programs, in addition to stopping other activities.

Although the FDA's homepage did not note the shutdown, making it appear like a normal day, the NIH's website features a big red box noting, “due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed,” and forwarding users to This second site's featured news included a note that the government had shut down and provided an 800 number to call for questions, which was followed by a second story on auto-rotate encouraging readers to sign up for health exchanges. These exchanges, part of healthcare legislation that put the government in deep freeze, began accepting members today. Money had already been allocated to the exchanges, insulating them from the standoff.

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