GDUFA Launch Pains: Facility List Fluctuations, Back-Due Backlog Fees

Article preview from “The Pink Sheet”-  February 18 , 2013

FDA still has backlog fees in arrears more than two months past the payment deadline, but cannot forcibly withdraw the applications; facility listings also change consistently because industry can update them as needed.

GDUFA Launch Pains: Facility List Fluctuations, Back-Due Backlog Fees

Article preview from “The Pink Sheet”-  February 18 , 2013

The first several months of FDA’s generic user fee program has produced the moderate set of hiccups that would be expected with the launch of any significant new system. But some of the remaining challenges illustrate just how difficult it will be for FDA to replicate the phenomenal success of the brand user fee program under the different sun of the generic drug industry.

Sixteen sponsors with pending generic drug applications remain in arrears with FDA for not paying the associated user fee nearly three months after the payment deadline.

But while FDA continues chasing the generic drug user fee scofflaws, it cannot entirely clear the backlog as long as fees are outstanding.

Generic drug facility listings data also continue to fluctuate, sometimes day-to-day, even though FDA set the fiscal year 2013 facility user fees several weeks ago and the deadline to register passed more than a month ago.

The frequent changes seem to reflect a continuing interest in GDUFA, but also could affect the user fee revenue FDA receives.

Both likely generate unwanted administrative hassles for the agency, something it hoped to minimize when creating the program.

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