Pfizer Switches To Offense In Charity Co-Payment Suit Against HHS
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.
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Based on HHS’ interpretation of the Anti-Kickback Statute, 11 pharma companies, including Pfizer, have reached settlements on their programs offering financial assistance to Medicare patients trying to access treatment. Now the firm hopes its tafamidis program will help it win in court.
Federal watchdog group acknowledges proposed assistance program aligns with comments in a 2005 OIG advisory bulletin on patient assistance programs in Medicare Part D, but maintains the bulletin should not serve as a roadmap for a compliant program in this case.
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.