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Budget deal brings FDA back to life

US Congress agreement allows employees at the regulator to return to work
FDA headquarters White Oak

US Food and Drug Administration (FDA) employees returned to work yesterday after a 16-day furlough, thanks to an eleventh-hour deal by the US Congress to agree a budget and raise the country's debt ceiling.

Health and Human Services (HHS) Secretary Kathleen Sebelius said the partial government shutdown of the last few weeks had "imposed hardships on many employees as well as the public we serve."

The shutdown resulted in some 800,000 federal workers being sent home on unpaid leave on October 1, although the number fell to 350,000 a few days later after Congress agreed that Pentagon workers should return to work.

It now emerges that workers will be able to claim their back pay (although at the time of writing it appears contractors may not be so fortunate), and have been awarded a 1 per cent pay increase after a three-year freeze.

"In the days ahead, we will work closely with departments and agencies to make the transition back to full operating status as smooth as possible," said Office of Management and Budget (OMB) director Sylvia Burwell in a statement released yesterday.

The FDA was forced to furlough 45 per cent of its staff, around 6,600 people, and during the hiatus only handled work that was critical for the public health. Advisory committee meetings continued and there were a few new product approvals and alerts, although there are reports of delays for some products including a flu vaccine made by Protein Sciences.

The agency's lurch back to life prompted a flurry of alerts - including two more recalls of a sterile injectable for Hospira - and means that it will once again be able to accept user fees from drug sponsors.

News that the deadlock might be breaking came on Wednesday when the Senate cleared a compromise deal to finance the government through to January 15 and give the US leeway to continue to borrow money into February and perhaps March, voting 81-18 in favour of the proposal.

The House of Representatives followed suit a few hours later, voting 284 to 144 in favour the agreement with some Republicans joining forces with Democrats to usher it through for President Obama's signature.

In the wake of the vote Republican House Speaker John Boehner conceded that the party had lost its bid to force changes to Obama's signature healthcare reforms, which emerge from the process pretty much unscathed.

Both sides have blamed each other for the impasse - which caused the US government's first shutdown since 1996 - but the threat of massive economic disruption by a US default on its debts forced an uneasy truce.

The big question now is whether a more long-term solution can be negotiated to avoid a similar debacle when the next budget and debt ceiling deadline looms over the winter.

Article by
Phil Taylor

18th October 2013

From: Sales, Regulatory, Healthcare

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