With Government Shutdown, FDA's Project to Replace MAUDE on Hold

Posted 10 October 2013 | By

The shutdown of the US government-and by extension much of the US Food and Drug Administration (FDA)-has received a great deal of attention, particularly from the standpoint of how it's currently effecting agency operations. But just as important may be how it is effecting the operations of another group of workers the agency heavily relies upon: outside contractors and vendors.

PRIMO on Hold

Focus caught up this week with Seth Warhaftig, president and CEO of the November Research Group (NRG), which recently won a contract with FDA's Center for Devices and Radiological Health (CDRH) to replace its aging Manufacturer and User Facility Device Experiences (MAUDE) system with NRG's PRIMO (pharmacovigilance report intake and managed output) system.

PRIMO, as with MAUDE, would be tasked with collecting adverse event reports for medical devices, known as medical device reports (MDRs). CDRH has been looking to replace the MAUDE system for several years, with Director Jeffery Shuren joking that it is old enough to belong in a museum.

But according to Warhaftig, industry may have to wait a bit longer for the system to arrive. "We received a stop order on the implementation portion of the project [because of the shutdown]," he told Focus. "The shutdown is definitely not a good thing in general for our work with FDA."

The project, he said, is "on pause" until the government shutdown ends, though it will reportedly not impact any of the work the company is doing on its own to customize the PRIMO software to FDA's needs. Only if the shutdown lasts a "very long time," it could eventually impact the project, he conceded.

The Benefits of PRIMO

Which is a shame, he adds, because the PRIMO system has a lot to offer both industry and FDA.

PRIMO is already used by several companies, including Sanofi and Biogen Idec, who use it as part of their intake review and triage systems for responding to adverse event reports, says Warhaftig.

And NRG already has extensive experience working with FDA, having been subcontractors on the Adverse Event Reporting System (AERS) implementation project still used within the Center for Drug Evaluation and Research (CDER).

"We've been very pleased with our interactions with FDA so far," he says. "We've been surprised at how well thought-out the entire solution is, how smart and technology-focused the team there is, and how knowledgeable they are about process automation and team like PRIMO."

Regulators will eventually have additional features at their disposal, Warhaftig said. "PRIMO is based on very modern technology. From a technical platform perspective, this will allow it to be much more highly scalable, much more available and much more accessible. It's much better than anything else FDA is currently using [for adverse event tracking]," he said.

The effects of these improvements will permit the agency to more rapidly review data, obtain better and faster results, conduct advanced reviews of data (e.g. to find potential trends), and send out correspondence to companies even faster. While PRIMO itself doesn't do analytics, the data architecture it uses supports several prominent data standards such as HL7 and eMDR.

All of this, however, assumes the project can eventually be implemented. And until the government shutdown ends, that will have to wait.


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