FDA Data Mining Project Proposal Once Again Withdrawn

| 04 April 2014 |  By 

Earlier this week, Focus reported that a data mining project once abandoned by the US Food and Drug Administration (FDA) for lack of funding had been resurrected by the agency. Now, just days after the agency announced the project's return, it is once again cancelling the project-for now.


FDA's data mining proposal has been in the works for more than a year. In April 2013, the agency established a notice indicating that it wanted to work with an outside company to build a safety prediction and data mining tool to help it better assess drug adverse event safety signals.

That solicitation, which Regulatory Focus wrote about at the time, later morphed into a more thorough (and slightly different) document package, complete with several responses to industry questions by FDA.

Then, in September 2013, FDA canceled the funding announcement citing a "lack of funding." It was unclear at the time if the cancellation was the result of budget woes, or simply a shift in internal priorities at the agency.

But on 31 March 2014, FDA reissued the announcement, calling for a "data mining tool for quantitative adverse event signal detection in literature reports."

As described by FDA in the notice, the project would establish a Pharmacological Mechanism-Based Drug Safety Prediction" (PMDSP) program, which would "develop predictions for safety signals that have not yet been recognized for drug candidates that have come to the FDA as New Drug Applications (NDAs)."

"An important goal is to allow the development of prospective hypotheses to provide to Office of Surveillance and Epidemiology (OSE) and Office of New Drugs (OND) to inform their evaluation of potential safety signals with the goal of reducing time and effort spent on false positive signals," FDA wrote.

Three Days Later … Gone

But if regulatory professionals were interested to see what effect-if any-the program would have on drug approvals, updates and withdrawals, they'll have to wait a while longer.

The contract, until further notice, "is hereby canceled," FDA wrote in a 3 April 2014 update to its original contract notice-just four days after it was posted.

FDA did not provide any reason for the cancellation, saying only that it will "re-advertise [the contract solicitation] at a later date."

FDA Solicitation on Data Mining


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