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

Executive Summary

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.

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