Backlog Backfire: FDA Sees Increase In Pending Generic Applications At Deadline

The agency was expecting many pending generic drug submissions to be withdrawn because sponsors would not want to pay the one-time backlog fee, but instead saw a substantial increase near the end of FY 2012.

It appears FDA’s generic drug application backlog did the exact opposite of what the agency hoped when it asked sponsors to voluntarily withdraw inactive or unnecessary submissions.

Rather than decrease or plateau from the 2,500 submissions that were pending at the end of fiscal year 2011, the...