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US FDA Loses Orphan Exclusivity Case While HHS Wins Dismissal Of Pfizer Kickback Complaint

 
• By Brenda Sandburg

In rare loss for FDA, appeals court reverses district court decision tossing Catalyst’s suit over Orphan Drug Act, saying deference should not have been granted to agency’s interpretation. District court finds it is too early to rule on one Pfizer charity co-pay program but backs broad reading of Anti-Kickback Statute.

Win Lose
US government wins one pharma case and loses another. • Source: Alamy

The federal government lost one pharma case and won another in a pair of decisions issued last week. In a rare upset for the US Food and Drug Administration, an appeals court ruled against the agency’s interpretation of the Orphan Drug Act. And a district court threw out Pfizer Inc.’s complaint against the Department of Health and Human Services seeking a ruling that its proposed charity co-pay programs do not violate the Anti-Kickback Statute.

In the FDA dispute, Catalyst Pharmaceuticals, Inc. objected to the agency’s approval of Jacobus Pharmaceutical Co. Inc’s drug Ruzurgi (amifampridine) despite the fact Catalyst had orphan exclusivity for Firdapse (amifampridine)

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