Federal Court Holds FDA to 180-day Statutory Deadline for Approving Drug Marketing Applications

April 10, 2006 Download PDF

On April 10, 2006, the United States District Court for the District of Columbia issued a memorandum opinion in the case of Sandoz, Inc. v. Leavitt that is useful precedent for companies with drug applications languishing at the FDA. In this case, the court granted Sandoz’s motion for summary judgment concerning FDA’s inaction in processing the company’s marketing application for Omnitrope (somatropin [rDNA origin] for injection).

The application had been pending at FDA for over three years. Sandoz argued that FDA violated the 180-day statutory deadline for taking action on an NDA. FDC Act Œ_ 505(c). FDA had countered that the 180 day statutory time frame is “aspirational”, and the true time frame is governed by the PDUFA performance goals. The Court rejected FDA’s position, holding that the 180-day deadline is a mandatory obligation on FDA. The court stated that “”the mere fact that the FDA sets its aspirations somewhere below what the statute requires is not reason enough to ease the statutory provision. The FDA must comply with the statute, not visa-versa.”

Addressing the separate issue of whether FDA’s violation merits equitable relief, the court found that, although there is precedent against judicial action to redress agency delays, even when violative, in this case the delay was unreasonable. The court ordered FDA to approve the application or provide Sandoz with a notice of a hearing.