Regulatory Focus™ > News Articles > Funding Uncertainties Hit FDA's Purchasing Decisions for First Time in a Decade

Funding Uncertainties Hit FDA's Purchasing Decisions for First Time in a Decade

Posted 18 March 2013 | By Alexander Gaffney, RAC 

If you want to see the effects of budgetary uncertainty on the US Food and Drug Administration (FDA), you need look no farther than its federal contracting page, where for the first time in more than a decade the agency says one of its contracts is "subject to availability of funding."

The request for proposal (RFP), "Two Triple Stage Quadruple MS/MS Systems" was opened on 15 March 2013, and is fairly commonplace as far as funding announcements go. In it, FDA said its Office of Acquisitions and Grant Services is seeking two ThermoFisher TSQ Vantage systems. The devices, made by Thermo Scientific, are used to analyze molecules, peptides, biosimilars, biologics and assays.

The RFP doesn't specify the cost of the acquisition, but listing of the device on other websites had the device's list price as going for $450,000 in 2009-a price that could well be lower by now.

But attached to the RFP is an announcement that FDA has not used in any other funding announcement going back to the earliest RFP and funding announcement on record in October 2001.

That phrase: "Subject to availability of funding."

"Please note that this is subject to availability of funding," FDA explains in its notice. "We ask that all quotes provided remain valid until 30 September 2013." That marks the end of the appropriations fiscal year.

In other words, FDA wants the devices, but isn't sure if it's going to have the money to pay for them.

The likely culprit behind that budgetary uncertainty is the recent effects of budget sequestration, which are slated to take approximately $210 million from the agency through the end of the year, and more than $300 million every year thereafter. While FDA has noted that it intends to comply with the cuts by slimming back on travel, training and other related expenses, this would be the first indication that it intends to subject contracts to the same sequestration process.

Another possibility is that the agency is holding off on purchasing until the next fiscal year to stretch its current resources, already strained as the sequester has removed tens of millions in user fees that ordinarily would have been paid to the agency. Some of those fees are meant to provide funding for FDA to conduct facility and capacity upgrades, of which the ThermoFisher devices would likely be a part.

While the purchase wouldn't affect FDA's main White Oak campus where regulatory decision-making takes place, it would affect its Kansas City District Laboratory and its Denver District Laboratory. District offices are most often charged with testing regional drug quality and conducting inspections to ensure that products are of sufficient quality and purity.

We've reached out to FDA for comment and will update this space if we hear back.


Tags: Purchasing

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe