1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

US FDA Is Pulled Into Zofran Product Liability Litigation

 
• By Brenda Sandburg

Agency officials meet with GSK and plaintiffs' steering committee in wake of GSK citizen petition; judge asks FDA to resolve petition 'expeditiously' as it could impact resolution of preemption dispute and the outcome of the litigation alleging Zofran caused birth defects.

Building icon with inscription FDA.
FDA's response to citizen petition could determine the outcome of Zofran product liability litigation.

While the US Food and Drug Administration's actions on drugs are typically cited in product liability litigation, the agency does not play a direct role in these cases. But through the filing of a citizen petition, GlaxoSmithKline PLC has drawn the agency into multidistrict litigation alleging GSK failed to warn of the risk of birth defects with use of its antiemetic Zofran (ondansetron) during pregnancy.

The 1 November citizen petition led FDA to hold separate "listening meetings" with GSK and members of the plaintiffs' steering committee to hear their views on what impact FDA's...

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 Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

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.

More from Agency Leadership

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.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.