## Facts

- Eagle Pharmaceuticals, Inc. developed Bendeka (bendamustine hydrochloride) for certain rare cancer indications and received orphan-drug designation from FDA in June 2014.
- A prior bendamustine product, Treanda, had been approved for the same indications and had received a seven-year orphan exclusivity period (2008–2015).
- FDA approved Bendeka in December 2015 for the designated indications but denied Bendeka seven-year orphan-drug exclusivity.
- FDA reasoned that Bendeka and Treanda were the “same drug” (same active moiety) and that Bendeka had not shown “actual clinical superiority” over Treanda at the approval stage, as FDA required by regulation for later-in-time drugs with the same active ingredient.
- Eagle sued under the Administrative Procedure Act, arguing that the Orphan Drug Act required exclusivity once a designated drug was approved for its designated disease or condition.
- The district court granted summary judgment for Eagle and ordered FDA to recognize Bendeka’s exclusivity; FDA appealed.

## Issues

1. Whether the Orphan Drug Act permitted FDA to condition seven-year orphan-drug exclusivity on a post-approval showing of “clinical superiority” over a previously approved drug with the same active ingredient.
2. Whether FDA’s clinical-superiority condition for exclusivity was entitled to Chevron deference.

## Decision

- The D.C. Circuit held the statute unambiguously grants seven-year exclusivity once a drug is both designated as an orphan drug and approved for the designated disease or condition.
- FDA lacked authority to deny exclusivity based on failure to prove post-approval clinical superiority.
- Because the statute was unambiguous, Chevron deference did not apply to FDA’s contrary interpretation.
- The court affirmed the judgment requiring FDA to recognize orphan-drug exclusivity for Bendeka (as governed by the statute in effect at the time of Bendeka’s approval).
- A dissent would have treated the statutory language as leaving room for FDA to require a showing of clinical superiority to avoid serial exclusivity.

## Legal Principles

- When Congress sets a statutory entitlement triggered by specified conditions, an agency may not add extra-statutory prerequisites to narrow that entitlement.
- Chevron deference is unavailable at step one where the statute directly answers the interpretive question.
- Agency regulations may address statutory gaps, but they may not override clear statutory text by imposing additional conditions on benefits the statute provides.

## Conclusion

The court required FDA to grant orphan-drug exclusivity to a designated drug upon approval for its designated indication, rejecting FDA’s attempt to withhold exclusivity based on a post-approval clinical-superiority requirement not found in the statute.


Eagle Pharmaceuticals, Inc. v. Azar, 952 F.3d 323 (D.C. Cir. 2020)