Pfizer Agrees To Oversight Of Charitable Assistance Programs In DOJ Settlement
Second pharma charity kickback settlement in six months resolves claims Pfizer used charity to pay Medicare patient copays for three drugs.
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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.
Pfizer is one of 10 pharma companies that have reached settlements with the US Department of Justice over their relationships with co-pay assistance foundations. It now seeks a declaratory judgement that proposed programs for its heart drug tafamidis do not violate the anti-kickback statute.
Jazz, Lundbeck and Alexion settle DoJ allegations they paid kickbacks through co-pay assistance foundations, but only two of them enter corporate integrity agreements.