US FDA Office of Generic Drugs backlog growth unabated

The Abbreviated New Drug Application backlog in the US Food and Drug Administration’s Office of Generic Drugs continued to grow unabated in 2010. The OGD started out the year with a backlog of 1,963 original applications and ended the year up almost 400 applications, for a grand total of 2,361 pending original ANDAs.

The backlog has, not surprisingly, affected median ANDA approval times, says Kurt Karst of law firm Hyman, Phelps & McNamara on its FDA Law Blog. In fiscal year 2009, the OGD’s median ANDA approval time was 26.70 months. That was up about 5 months compared to fiscal 2008 when the median was 21.65 months. At the end of calendar year 2010, Mr Karst said he understand that the median ANDA approval time (which includes tentative approval actions) was hovering around 31 months.

“That has got to give some folks in industry indigestion, as 180-day exclusivity can be forfeited if an ANDA sponsor fails to obtain tentative ANDA approval within 30 months of application submission. FDA’s position has been that the agency’s failure to timely grant tentative approval does not save an ANDA sponsor from forfeiture,” he said.