RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > Citing Funding Woes, FDA Cancels Adverse Event Safety Mining Project

Citing Funding Woes, FDA Cancels Adverse Event Safety Mining Project

Posted 11 September 2013 | By Alexander Gaffney, RAC

Funding woes have caused the US Food and Drug Administration (FDA) to cancel a proposed project that would have seen it mining drug adverse event safety signals from literature reports.


FDA regularly puts out requests for proposals and solicitations on the Federal Business Opportunities (FBO) website, and lately has expressed a keen interest in methods of monitoring adverse event data.

In April 2013, for example, it put out a notice indicating it wants a partner to help it build a safety prediction and data mining tool to help it better assess drug adverse event safety signals as early as possible.

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.

The gist of the program, as explained by FDA, is to adopt earlier recommendations by its Science Board to make it easier to mine data and recognize adverse event safety signals automatically.

"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 in the notice.

The intended tool would automatically search the MEDLINE database's massive store of literature reports-a monumental task that might ordinarily take a large team of dedicated and highly educated FDA staff to accomplish.


However, in a new notice on the FBO website, FDA says the entire funding announcement has unfortunately been for naught.

"Due to lack of funding, the requirement has been cancelled," FDA wrote. In a follow-up email to Regulatory Focus, Contract Specialist Trevor Edwards confirmed that, "The entire procurement was cancelled."

The work was originally to start focusing on fluoroquinolone products and lipid-lowering drugs, both products with known safety issues.

It is now unclear whether FDA will resuscitate the program at a later date if its funding situation improves, or whether this is itself an adverse event of budget sequestration.

FBO Cancellation Notice


© 2022 Regulatory Affairs Professionals Society.