Sun Pharma Advanced Research Co., Ltd. v. Becerra

Summary

The court held that the FDA unlawfully denied Sun Pharma a rare pediatric disease priority review voucher after approving Sezaby, a treatment for neonatal seizures. It concluded that a drug application deemed approved under the transitional provisions of the 1962 FDA Amendments was not an application previously approved under the Hatch-Waxman pathways referenced in the voucher statute. The court granted Plaintiffs’ motion for summary judgment and denied Defendants’ cross-motion.

Holdings

1. An application that was merely deemed approved under the 1962 amendments, after becoming effective through agency inaction under the prior statutory regime, was not previously approved under 21 U.S.C. § 355(b)(1), (b)(2), or (j) for purposes of the Section 529 priority review voucher program.
2. The FDA acted contrary to law when it denied Plaintiffs a priority review voucher on the ground that phenobarbital sodium had been previously approved in NDA 000597.

Questions Presented

1. Whether an application that became effective by agency inaction under the original Food, Drug, and Cosmetic Act and was later deemed approved under the 1962 amendments constitutes an application containing an active moiety that was previously approved under 21 U.S.C. § 355(b)(1), (b)(2), or (j) for purposes of the Section 529 priority review voucher statute.
2. Whether the FDA acted contrary to law by denying Plaintiffs a rare pediatric disease priority review voucher based on NDA 000597.

Disposition

other