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

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

[Editor’s note: This story appeared first in our sister publication, Pink Sheet.]

More from Legal

More from Pink Sheet

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By 

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.

Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By 

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.

CMS Nominee Oz Nears Confirmation Despite Concerns About Medicaid Cuts

 
• By 

Democrats opposed the nomination because they believe Mehmet Oz will not defend Medicaid from spending cuts. His pledge to continue lowering drug costs in Medicare and Medicaid did not offset the concerns.