1. Pink Sheet

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

 
• By Sarah Karlin-Smith, Elizabeth Orr, and Derrick Gingery

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

EU and US flags side by side.
Europe may be the big winner after the Trump Administration's layoffs at FDA. (Shutterstock)
Key Takeaways
  • Medical product reviewers were spared during the 1 April layoffs at FDA, but cuts to support and policy staff likely will slow drug development and approval, experts said.
  • The result could be that the US loses its status as the first region companies turn to for product approval.
  • The nature of the 3,500-person reduction-in-force also is expected to increase voluntary departures in application review-related positions.

The speed of US medical product reviews likely will be slowed by the approximately 3,500 US Food and Drug Administration job cuts made 1 April, which experts expect will propel...

Ultimately “US patients and the US economy will suffer,” said Howard Sklamberg, a partner at Arnold and Porter and a former FDA deputy commissioner for global regulatory operations and policy....

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 US FDA

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

More from Pathways & Standards