The US Supreme Court is set to hear one case this term that could bolster the biopharma industry’s ability to challenge US Food and Drug Administration rules and it is likely to take up another case that would undermine industry's reliance on agency decisions.
Mifepristone Ruling Casts ‘Shadow Of Uncertainty’ Over Every FDA Approval, Biopharma Industry Tells Supreme Court
As the new Supreme Court term begins, PhRMA and a host of biopharma CEOs and investors implore justices to take up mifepristone case to prevent chaos for drug development. High court will also consider a lawsuit that would reduce deference to federal rulemaking and it may consider another that would increase corporate liability under the Anti-Terrorism Act.

More from Legal & IP
More from Pink Sheet
Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.
The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.