Senator Sends Letter to Califf Seeking Information on ANDA Backlog

Refuting testimony provided by CDER Director Janet Woodcock during a Senate HELP Committee hearing, Sen. Tom Cotton (R-Ark.) sent a letter to new FDA Commissioner Robert Califf seeking information on the agency’s ANDA backlog.

A member of the Senate Committee on Aging, Cotton writes that there are roughly 3,875 ANDAs pending approval, at the same that prescription drug costs in Arkansas exceeded $2.5 billion in 2014. He described the backlog as “urgent,” pointing to academic studies that show the price of a drug decreases by more than half after a second generic is approved.

CDER Director Janet Woodcock testified before the Senate HELP Committee in January that the FDA has met — and in many cases exceeded — all GDUFA goals established since its passage in 2012, and that that the agency would clear out the backlog prior to the expected renewal of GDUFA in fiscal 2018. She added that many ANDAs are rejected because of insufficient information or low-quality data from sponsors.