1. Pink Sheet
  2. >>Market Access

US Medicare Price Negotiation: Gaming FDA Approval Dates Could Delay Drug Selection

 
• By Cathy Kelly

The early February date for publishing the list of products eligible for price negotiations could dictate approval strategies for drugs with potential for big sales in Medicare going forward.

Early February may become an extremely busy period for FDA approvals. • Source: Shutterstock

The US Food and Drug Administration may find that the flow and approval of new drug and biologic applications going forward are influenced by the Inflation Reduction Act’s timeline for when drugs become eligible for Medicare price negotiation, regulatory attorneys suggested during a 25 January Food and Drug Law Institute webinar.

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 Market Access

Stand-Alone PDP Market Lives to Fight Another Day, Enrollment Data Shows

 
• By Leslie Small

No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

Europe Should Pay Drug Prices More In Line With US, Two Pharma CEOs Argue

 
• By Kevin Grogan

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.

Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 
• By Eliza Slawther

Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

More from Pink Sheet

Stand-Alone PDP Market Lives to Fight Another Day, Enrollment Data Shows

 
• By Leslie Small

No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

Gene Therapy Sponsor INTERACT, Pre-IND Meeting Confusion Lingers Despite FDA Guidance

 
• By Sue Sutter

PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.

Europe Should Pay Drug Prices More In Line With US, Two Pharma CEOs Argue

 
• By Kevin Grogan

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.