Intellectual Property Law

In a rebuke to the FDA, the United States District Court for the District of Columbia last week ruled that the FDA?s failure to act on a New Drug Application (?NDA?) filed by Sandoz, Inc. within 180 days violated a Congressional mandate. The court entered summary judgment in favor of Sandoz and ordered the FDA ?to take appropriate action? to issue a decision on Sandoz? NDA.

Sandoz filed an NDA in July 2003 for approval of Omnitrope, a recombinant human growth hormone. Sandoz? application relies in part on a prior finding by the FDA that a supposedly similar compound ? but not an exact equivalent ? is safe and effective. Because Omnitrope is not an exact equivalent of the approved compound, Sandoz submitted an NDA instead of an abbreviated NDA, but relied on prior studies under 21 U.S.C. section 355(d) rather than extensive new testing to support its application.

When the FDA had not rendered a decision on the NDA within 180 days, Sandoz filed suit in the United States District Court for the District of Columbia against the Secretary of Health and Human Services and the Commissioner of the FDA ? Sandoz Inc. vs. Michael O. Leavitt and Lester M. Crawford. Sandoz? complaint asserts that the FDA failed to comply with the provisions of 21 U.S.C. section 355(c)(1) that it approve an NDA within 180 days after filing unless it finds ?that none of the grounds for denying approval? exists. According to Sandoz, the FDA?s failure to act on the application is ?arbitrary, capricious and an abuse of discretion? and, therefore, unlawful under 5 U.S.C. § 706. For its part, the FDA contends that the 180-day language of section 355(c) is ?aspirational? rather than mandatory and that it has acted reasonably with respect to Sandoz? application.

The parties made cross-motions for summary judgment, and on April 10, 2006, the district court granted Sandoz? motion and denied the FDA?s motion. The court found that section the 180-day provision of section 355(c) ?imposes a mandatory obligation on the FDA? and that the FDA failed to act in accordance with that mandate. The court held that the FDA?s failure to act on Sandoz? NDA within 180 days was unreasonable and ?intolerable? because the FDA had prioritized other NDAs over Sandoz?. The granting of Sandoz? motion is not an order that the FDA approve Sandoz? NDA, but merely a directive that it give Sandoz ?a notice of a hearing before the Secretary on the question of whether the plaintiff?s application is approvable.?

The FDA will almost certainly appeal the district court?s ruling, so the matter will not end here. Stay tuned to the Blawg for future developments.

Today's Blogger:  Bob Sloss