1. Pink Sheet

Pfizer Case May Be ‘Only Chance’ For Supreme Court To Save Co-Pay Charity Assistance Programs

 
• By Brenda Sandburg

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.

Copay pills 20 dollar bill
Pfizer asks Supreme Court to review application of Anti-Kickback Statute to charity co-pay assistance programs • Source: Shutterstock

Pfizer Inc. is hoping to use its tafamidis co-pay support plan as the vehicle to try to halt the US government’s targeting of charity assistance programs for Medicare patients as a violation of the Anti-Kickback Statute (AKS).

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legal & IP

More from Pink Sheet

Brazil’s ANVISA Clarifies Registration Procedures For Biologicals

 
• By Francesca Bruce

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 
• By Francesca Bruce

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLA

 
• By Bridget Silverman

Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.