US Furlough to impact FDA Submissions

[otherottawaguy]

from YMB - Snortinnortin10

No Submission During Furlough
Industry Notification: Furlough
Oct. 1, 2013

In the absence of either an FY 2014 appropriation or a Continuing Resolution for FDA, beginning on October 1 and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution ("lapse period"), agency operations will be limited to the following:

Emergency work involving the safety of human life or the protection of property;
Criminal law enforcement work; and
Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA) , Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted. This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.


Comments?

[goyocafe]

Well, they'll lack enforcement personnel as well, so just start selling the stuff already! (Not sure if it would be considered "criminal", so maybe they would still send in armed agents.)

[liane]

Well, just to muddy the water...

www.fiercebiotech.com/story/what-happens-fda-government-shutdown/2013-09-30

UPDATED: What happens to the FDA in a government shutdown?
September 30, 2013 | By Damian Garde


With hope for congressional compromise waning by the hour, the federal government is bracing for its first shutdown in 17 years, and for the FDA, that means furloughing about half its staff and ditching duties it can no longer afford. What that spells for drug developers with eyes on approval, however, remains murky.

If the government shuts down come Tuesday, the FDA will lose 6,620 employees, about 45% of its staff, and the agency would have to cease many inspections, enforcement actions and monitoring operations, also suspending the "majority" of its internal lab research, according to a Department of Health and Human Services briefing.

As for advisory panels, PDUFA dates and the agency services that affect the drug development world, things are more opaque. While the government is quite clear that only mission-critical, life-and-death work will continue, DHHS also said that the "FDA would continue limited activities related to its user-fee funded programs," which would include drug approvals.

Of course, the scope of the word "limited" remains unexplained, and the agency isn't in a position to be terribly specific about where advisory committees fit in. "Generally speaking, these meetings would continue in some way," an FDA spokesperson said in an email to FierceBiotech on Monday.

Next month alone, agency panels are slated to discuss an expanded indication for Amarin Pharmaceuticals' ($AMRN) much-scrutinized Vascepa and whether to approve Gilead Sciences' ($GILD) hepatitis C hopeful sofosbuvir. Postponing those meetings indefinitely would muddle launch timelines and rattle investor expectations, and a protracted shutdown would change the game for any drugmaker looking for near-term approvals.

As for the the steady stream of regulations the agency normally churns out, Regulatory Focus points out that all 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," which is to say the agency is unlikely to roll out any sweeping guidances with half its staff on a mandatory vacation.

Meanwhile, in Washington, DC, negotiations have stalled. As The Washington Post reports, House Republicans have passed a bill that would fund the government but gut the Affordable Care Act, sending it to Senate Democrats who have long promised to reject any measures that harm healthcare reform. Once they do just that, it'll be up to House Republicans to decide on a simple stopgap funding extension passed by the Senate last week. Few, the Post notes, are optimistic.

Read more: UPDATED: What happens to the FDA in a government shutdown? - FierceBiotech www.fiercebiotech.com/story/what-happens-fda-government-shutdown/2013-09-30#ixzz2gV7BeUTW
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[liane]

ANd more today:

www.fiercebiotech.com/story/despite-fda-shutdown-gilead-amarin-still-high-profile-panels/2013-10-01?utm_source=rss&utm_medium=rss

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.

Read more: Despite FDA shutdown, Gilead, Amarin still on for high-profile panels - FierceBiotech www.fiercebiotech.com/story/despite-fda-shutdown-gilead-amarin-still-high-profile-panels/2013-10-01#ixzz2gVFgKU9l
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[babaoriley]

Those shorties will stop at nothing, holding the entire government captive, just to knock down a couple of biotechs! What's next, a meteor strike on Al's head?