1. Pink Sheet
  2. >>Agency Leadership

Sen. Wyden Using Califf Nomination To Extract Accelerated Approval Reforms

 
• By Sarah Karlin-Smith

The unexpectedly tight fight to get Robert Califf confirmed as FDA commissioner is giving lawmakers additional leverage to extract commitments. However, the Senate Finance Chair may be overestimating FDA’s ability to swiftly pull accelerated approvals without new legislation.

boot on thin breaking ice
Califf’s nomination to lead FDA is on thin ice. • Source: Alamy

US Food and Drug Administration Commissioner nominee Robert Califf agreed to take fast and “strong action” to hold pharmaceutical companies accountable for producing the scientific evidence required of accelerated approval drugs if confirmed for a second chance at leading the agency, a 4 February letter from Senate Finance Committee Chair Ron Wyden says. 

Califf made the pledge to take action within 30 days of assuming office during a recent meeting with the Democratic...

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 Agency Leadership

More from Pink Sheet

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
• By Bridget Silverman

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
• By Derrick Gingery, Francesca Bruce, Cathy Kelly, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.