FDA Acting at Lower Capacity During Shutdown, But User Fees Helping

FDA Acting at Lower Capacity During Shutdown, But User Fees Helping

October 16th, 2013 // 6:32 pm @

FDA as of Oct. 1 is operating at about 1/2 its normal capacity, due to Congress not passing a bill to appropriate funds to operate the US government, according to FDA.

At the RAPS regulatory conference in Boston last week, the effects of the current shut down were evident. Even with hotel rooms already booked, many FDA officials were ordered to go back to Washington. However, some regulators still were available at RAPS to give their presentations.

The effects of the US government shutdown have been seen in other ways too. When RAPS officials tried to reach a top FDA official to get an FDA statement on the shutdown, it was discovered that that particular official had been furloughed.

According to another FDA spokesperson, Steve Immergut, the shutdown effects on FDA have been strong. About 45% of the staff of FDA are not allowed to work until more funded is given. About 75% of the FDA staff who are on the job are paid via user fees. If not for the user fees, they would have been furloughed as well. It is not clear at this time if they are going to get pay at the regular intervals.

Also, limited FDA activities are planned related to the user fee funded programs, including advisory committees. FDA said it would continue to have these meetings, but they may be done in less conventional venues. The meetings will probably continue in some way, however.

New drug applications, or NDAs, will not be taken with the shutdown in effect.

Some of the other limits on FDA activities include on low risk recalls; non emergency work; routine establishment audits, some lower priority compliance activity; import monitoring and lab research.


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