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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Pfizer Case May Be ‘Only Chance’ For Supreme Court To Save Co-Pay Charity Assistance Programs
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.
Cost Sharing Program In Part D From Coalition Of Cancer Drug Manufacturers Rebuffed By OIG
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.
US FDA Loses Orphan Exclusivity Case While HHS Wins Dismissal Of Pfizer Kickback Complaint
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.