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US shutdown threatens to disrupt FDA

Congress failure to agree budget cripples government functions
US congress

A failure by US Congress to thrash out an agreement on next year's budget has led to a partial shutdown of government functions, with the FDA also affected.

A midnight deadline to reach a deal - with the Republican-led House of Representatives refusing to back President Barack Obama's proposals -  passed without agreement and leaves more than 700,000 government workers facing unpaid leave until the issue can be resolved.

One of the sticking points in the negotiations has been Obama's healthcare reforms, including the Affordable Care Act (ACA) which includes an overhaul of the national health insurance system.

The House declined to pass the budget without a one-year delay to the ACA but any delay to 'Obamacare' would be politically damaging for the President, as the reforms have been the signature theme for his term in office.

The President's frustration was evident in a tweet posted last night: "They actually did it. A group of Republicans in the House just forced a government shutdown over Obamacare instead of passing a real budget."

The President's Office of Management Budget (OMB) sent out a letter this morning ordering federal agencies to "execute plans for an orderly shutdown" until Congress agrees to fund government once again.

Some government-funded staff - including military personnel working in uniform - will continue to be paid under separate legislation passed by Congress, said Obama in a televised address this morning.

The impact of the shutdown on the running of the FDA remains to be seen, but earlier this month it was suggested by the Department of Health and Human Services (DHHS) that around 55 per cent of the agency's 14,779 staff would be asked to remain at work, while the remainder (around 6,600 people) would be furloughed.

Routine inspections, lab research and enforcement actions will be interrupted, although the regulator will continue "limited activities related to its user fee funded programmes", according to the DHHS.

The FDA will continue "select vital activities", it says,  including "maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues."

It is still not clear whether advisory committee meetings will continue to be run in the interim or postponed, and it looks likely that the issuance of guidance documents and regulations will be placed on hold unless they are critical to public health.

This is the first shutdown of the US government since 1996, when the crisis was once again precipitated by an impasse between a Democratic President (Bill Clinton) and a Republican-led House.

That shutdown lasted 21 days but was caused by differences of opinion on fiscal policy, rather than ideological and political differences, and all bets are off on how long the current hiatus will last. And with the US heading for its debt ceiling limit in mid-October, the Government could face even bigger problems if it starts to default on payments, with knock-on impacts on industry and investors. 

Article by
Phil Taylor

1st October 2013

From: Regulatory, Healthcare



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