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

 
• By Sue Sutter
  
Generate a summary of this article
Listen to this article
Beta

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.

Key Takeaways

  • Sponsors can take a more forceful position with the FDA in prelitigation disputes now that agency decisions are not afforded Chevron deference by courts.

However, the FDA is likely to take much longer to make decisions on regulatory and legal questions. The agency will...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Legal & IP

UK MHRA First-Half New Drug Approvals Show Overwhelming Use Of EU Reliance Procedures

 
• By Ian Schofield

The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 
• By Francesca Bruce

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

US FDA Biologics Designation As Price Protection: Lilly Charts New Course With Retatrutide

 
• By Cathy Kelly

An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.

Glenmark Shells Out Another $25m To Resolve Civil Price-Fixing Charges

 
• By Dave Wallace

Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.

More from Pink Sheet

COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
• By Sue Sutter

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

Nancy Tests New Podcast Template

 
• By Derrick Gingery

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

PinkSheet-R&D-Free: ‘Ranking’ article that includes different Composer content

 
• By Nabil, Olga Zviezdicheva, Reed Miller, Mary Jo Laffler, Ian Schofield, João Andrés-Ruíz de la Fontaine-LeBlanc, Chloë Anastasía-Stojanović del Castillo-Ribeirão, and Nabil

To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.