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Government Shutdown Leaves FDA Operating at Reduced Capacity, But User Fees Act as Agency Savior

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By Alexander Gaffney, RF News Editor

BOSTON - The US Food and Drug Administration (FDA) is, as of 1 October 2013, operating at just above half capacity thanks to a failure of the US Congress to pass a bill appropriating funding for the US government, agency officials said.

At the Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence conference in Boston, MA, the effects of the shutdown were at least partially evident. Several agency officials, despite having already booked hotel rooms and travel, were ordered back to Washington, DC immediately. The effects, however, were not uniform, with various other regulators remaining to give presentations to regulatory professionals.

But the effects of the shutdown have already shown themselves in other ways as well. When Regulatory Focus attempted to reach a high-ranking official within FDA's office of media affairs in the hopes of obtaining a statement on FDA's response to the shutdown, we immediately received an automatic reply that the official had herself been furloughed.

Focus eventually got in touch with Steven Immergut, another FDA spokesman, who elaborated on the practical effects of the shutdown.

The facts and figures are stark: 45% of the agency's staff is not permitted to work until funding is provided. Nearly 75% of FDA staff remaining on the job are funded through industry-paid user fees, otherwise they would likely be furloughed as well. It was not immediately clear if they would receive pay at the usual intervals.

Meanwhile, "limited activities related to FDA's user fee-funded programs" are set to continue, including some of the most high-profile: Advisory committees. The agency said it would continue with the meetings, at which expert panelists make recommendations on whether the agency should approve a particular product, but could be conducted in less conventional formats. "Generally speaking, these meetings would continue in some way," said another spokesman earlier in the week.

New Drug Application (NDAs) would not be accepted while the shutdown is in effect.

Other limitations on FDA staff activity is set to include moderate- to low-risk recalls, non-emergency activities, routine establishment inspections, some compliance and enforcement activities, import monitoring and laboratory research activities.

As of the writing of this piece, a legislative compromise still seemed out of reach. House Republicans have insisted on attaching conditions to an appropriations bill, while Democrats have sought the same appropriations bill free of all legislative "riders."

Whatever the solution, FDA is for the time being a casualty of congressional gridlock. 




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