Regulatory Focus™ > News Articles > Shutdown Leads to New Record Low for FDA Warning Letters

Shutdown Leads to New Record Low for FDA Warning Letters

Posted 15 October 2013 | By Alexander Gaffney, RAC

Regular watchers of the US Food and Drug Administration (FDA) know one thing about Tuesdays: It's Warning Letter day, the weekly Christmas for those who take enjoyment from reading through occasionally arcane enforcement and advertising policy. For some-and we count ourselves among them-FDA's Warning Letter postings are a regular source of the alarming and interesting, often in equal measure.

But these past two weeks have been anything but regular.

Since 1 October 2013, when US legislators failed to reach an accord on Fiscal Year 2014 spending levels, the government has been partially shut down. At present, only those staff at FDA deemed "essential" or being paid by industry-paid user fees carried over from the prior fiscal year are able to work.

That's left 45% of FDA on furlough and the agency unable to conduct many of its routine tasks, including, it seems, processing Warning Letters.

Prior to the shutdown, an average week for Warning Letters-which are used by FDA to threaten impending action if deficiencies are not corrected to its satisfaction-was somewhere in the range of 10-20 letters, with some addressing food and tobacco products.

But once the shutdown went into effect, the agency immediately warned that all activities not related to protecting human life or involving criminal law enforcement work would be suspended. In practical terms: No routine inspections without cause.

And since those inspections are often the first step in the issuance of many Warning Letters, that's left precious little to write about.

Last week, FDA released just seven letters, with all but three going to medical device manufacturers.

This week, however, may mark a new record low: Zero letters.

The cause, we should note, is likely less related to a lack of inspection than a lack of staff on board to process those inspections and pen the Warning Letters. Many letters reference inspections that took place months-sometimes approaching a year-prior. But with many of FDA's legal experts and inspectors on furlough, it's likely that many of its letters are currently on hold.

But with the dearth of inspectional capacity at the moment, it could be weeks-if not months-before we start to see the usual numbers of Warning Letters we've come to expect each week. And since the letters often reflect the agency's evolving enforcement approach, that could leave industry with a more difficult time understanding FDA's intentions in the future.

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