1. Pink Sheet
  2. >>Legal & IP

Chevron’s Fall Strengthens Industry’s Hand In Disagreements With US FDA, But May Spur Delays

 
• By Sue Sutter

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

Produce
What types of FDA disputes are ripe for litigation in a post-Chevron world? • Source: Shutterstock

Biopharma companies that have a prelitigation dispute with the US Food and Drug Administration will be in a stronger position to argue their views before the agency now that the US Supreme Court has overturned the Chevron doctrine of deference.

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

Lilly Targets Sale Of Repackaged, Redosed Zepbound, Mounjaro In Lawsuit

 
• By Cathy Kelly

Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.

Mifepristone Filing Supports 2023 US FDA Actions, But Experts Caution Against Overanalyzing

 
• By Sarah Karlin-Smith

Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.

Supreme Court May Be Next After Federal Circuit Refuses To Rehear Teva Inhaler Patents Case

 
• By Urtė Fultinavičiūtė

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

HHS Wants 340B Rebate Debate Out Of Courts, Returned To Government

 
• By Cathy Kelly

An HHS legal brief argues company lawsuits seeking immediate clearance to use rebates in 340B are premature and that the department has merely used a ‘measured approach’ in weighing the possibility. Past experience suggests otherwise, a pricing expert said.

More from Pink Sheet

ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines

 
• By Bridget Silverman

US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease