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And So It Begins …

March 1, 2013

The sequester starts at midnight tonight.  In the media, we have seen a charged partisan conversation about the overall impact on the government, with some predicting disaster and some predicting no change.  The White House, HHS and FDA have provided little information on the impact on FDA.

FDA on Wednesday announced there would be no furloughs for FDA employees. Undoubtedly, FDA leadership meant the “no furloughs” statement as a means to calm the fears of FDA staff. And hopefully it did.

However, in a vacuum — where little other information regarding sequestration’s impact on FDA is being provided — the statement “no furloughs” also creates problems. With other agencies, including NIH and CDC, being so explicit about the likely damage of sequester to their missions … “no furloughs” along with almost no other details gives the impression that FDA can weather a $210 million cut without severe consequences.

It can’t.

To make the numbers work without furloughs, a chunk of the savings will have to come from unfilled and/or delayed filling of vacancies — a process that probably started months ago. Many offices are probably already short-staffed and most will become so as we get deeper into the sequester. Hence, the predicted slowdowns in food inspections and drug and device reviews. In offices where staff reductions are needed as part of sequester but no vacancies exist, some appropriately qualified employees may be saved through internal transfers into slots that can be paid for by the Generic Drug User Fee program (FDA’s one big growth area this year and for which it will definitely need to be hiring).

This then suggests yet another reason why FDA may have been quiet. While $210 million is a large cut with severe consequences, it may well be achieved by a thousand little bits and pieces, a vacancy here, a training contract there, a bunch of cancelled plane flights, some underspending early in the year, etc. It doesn’t make for a very dramatic story, so maybe it was felt that it was fruitless, even counterproductive, to try.

The Alliance, however, can’t look at it that way. If food is less safe … if drug and devices reviews go more slowly … if problems with imports increase … and if regulatory science and agency modernization stall … then there is a huge loss to the American people.

This loss is made larger by our knowledge that the agency’s mission is not static. Congress has passed six laws since 2009 giving FDA substantially more responsibility. Globalization and complex science makes the agency’s job larger and more difficult each year.

FDA staff wasn’t large enough to get the whole job done last year. Problems will multiply quickly over the coming months as existing employees represent an every smaller proportion of the numbers needed to carry out this year’s and next year’s responsibilities.

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