FDA awards $300M in drug info system contracts

The Food and Drug Administration has awarded five-year contracts with a combined $300 million ceiling to four companies to develop and implement an information system for tracking and analyzing drugs, medical devices and other biological products.

Acumen, Dovel Technologies, IBM and IQVIA Government Solutions all received contracts worth up to $75 million each to support the FDA’s Biologics Effectiveness and Safety initiative. Awardees will provide data, tools and IT infrastructure for the so-called “BEST” effort, the FDA said in a Monday FedBizOpps notice.

BEST is part of the FDA’s overall “Sentinel” effort to adopt a technology environment that can help it evaluate safety of medical products with respect to health outcomes utilizing claims and administrative data from large health insurance companies.

Sentinel launched in 2009 and the FDA awarded a pair of one-year contracts to IMS Government Solutions last year to kick off BEST through pilots focused in part on bringing electronic health records into the data fold. IMS also tested artificial intelligence and machine learning tools to track data. Those contracts are slated to expire this year.

Solicitation documents on BEST call out blood, blood products, tissues, vaccines and other advanced therapeutics as post-market biological products the FDA wants to improve tracking of.

Awardees will build the IT infrastructure to handle multiple data sources in order to run queries and observational studies. They will also work with the FDA to develop a network to support analysis of large-scale health data that includes administrative, claims and EHR data.

Other goals for BEST include using partially-automated processes to streamline medical chart reviews.