FDA Appeals Omnitrope Case to D.C. Circuit

The FDA recently appealed the district court case that forced it to make a decision on Sandoz's drug application for Omnitrope, which later led to FDA to approve Omnitrope.  Sandoz has called Omnitrope the first ever biogeneric drug.

In a decision on April 10, the U.S. District Court for the District of Columbia held, on summary judgment, that 21 U.S.C. 355(c) requires the FDA act on a new drug application within 180 days of receiving it.  More specifically, within 180 days the FDA must either approve the new drug application or give the applicant notice of an opportunity for a hearing.

The FDA did not deny that it did neither of those things.  Instead, the FDA argued that the statute was aspirational rather than mandatory.  The FDA argued in the alternative that the court should respect the autonomy of the executive branch and let the FDA set its own priorities.

IN OTHER BIOGENERICS NEWS, FDANews is running a story tomorrow quoting a Senate staffer who said that Congress would likely not take up legislation establishing a regulatory pathway for biogenerics until 2008.

RELATED READING:

• previous Orange Book Blog posts on Omnitrope:  1 June 06 and 4 June 06

NOTE:  thanks to Kurt Karst for providing a copy of the FDA's Notice of Appeal.