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US shutdown starts to bite - UPDATED

Published on 02/10/13 at 11:12am
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Thousands of FDA employees have been forced to take unpaid leave

Twenty-four hours into the US government’s shutdown, the impact on pharma of the freezing of federal government activity remains hard to call.

While thousands of employees from the FDA have been forced to take unpaid leave (which the government refers to as being ‘furloughed’), the US regulator insists it will continue to carry out essential work.

Although it is not possible to discern what effect this might have on the FDA, the boss of the Centers for Disease Control and Prevention (CDC), Dr Tom Frieden, took a far less sanguine view of the shutdown.

He tweeted: “CDC had to furlough 8,754 people. They protected you yesterday, can’t tomorrow. Microbes/other threats didn’t shut down. We are less safe.”

The National Institutes of Health (NIH) will stop accepting new patients, while the Department of Health and Human Services has seen more than half of its nearly 80,000 staff sent home.

Essentially the two Houses of Congress have failed to agree a new budget for government activities - which means government agencies cannot be completely funded.

The blockage has come because Republicans wanted agreement of a new budget to be contingent on delays in the introduction of President Barack Obama’s far-reaching health reforms under the Affordable Care Act (the so-called ‘Obamacare’ programme).

Congress created Medicare, which guarantees government-backed health coverage for old people, as long ago as 1965: however, Obama’s flagship goes much further by allowing those who do not have insurance - or who have pre-existing medical conditions - to buy government-subsidised healthcare packages.

Its aim is to reduce health inequalities, such as the trend which sees poorer people not coming onto the radar for treatment until crisis point is reached, making their first engagement with the system a visit to A&E (or ER).

A week-long shutdown would cost the US economy $10 billion, and the US Treasury suggests its funds will run out if the impasse lasts until 17 October - a state of affairs which could then see the US government defaulting on debts which would have far-reaching repercussions for the global economy.

Squabbles over the US federal budget leading to a partial suspension of government activities are not new - the last happened 17 years ago during the administration of president Bill Clinton.

UPDATED

The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of the government shutdown, it has been announced.

Stephen King, a member of CDER’s communications team at FDA, has said that “no new regulatory submissions that have fees attached” – including NDAs – “will be accepted for 2014 until the date of enactment of a [fiscal year] 2014 appropriation or a Continuing Resolution.”

King did not respond to the question from the Pharmaceutical Executive of whether products already accepted for FDA review would face potential delays as a result of the shutdown.

While FDA awaits a budget appropriation or continuing resolution, it will be limited to the following tasks, according to an offical statement released today:

  • 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).

As part of the Department of Health and Human Services' (HHS) contigency plan for the shutdown, FDA will be “unable to support the majority of its food safety, nutrition, and cosmetics activities".

The agency will also have to "cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programmes and the majority of the laboratory research necessary to inform public health decision-making.”

Adam Hill

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