1. Scrip
  2. >>Business
  3. >>Legal & IP

SCOTUS' Mifepristone Decision Sets High Bar For US FDA Suits

Agency Authority Still Faces Risks

 
• By Sarah Karlin-Smith

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits. 

female athlete performing high jump
The US Supreme Court abortion pill opinion sets a high bar for FDA lawsuits, but future tests of FDA's authority remain a risk. • Source: Shutterstock

The US Supreme Court’s unanimous decision to dismiss a high-profile case challenging the US Food and Drug Administration’s regulation of the abortion pill mifepristone on the grounds the plaintiff lacked standing set a high bar for future legal challenges of the agency decisions.

Key Takeaways

  • The unanimous Supreme Court ruling in the mifepristone case will limit the types of challenges that can be brought against FDA approval decisions and create some stability and predictability for industry.

But the 13 June ruling does not reassure that the court would defer to the FDA’s expertise and refrain...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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

Regeneron Wins PCSK9 Court Battle Against Amgen

 
• By Alaric DeArment

A federal court jury found Amgen liable for violating antitrust laws in allegedly preventing Praluent from competing against Repatha.

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

OPPI’s Matai On Section 3(d) Of India’s Patent Regulations: Now’s The Time To Open Up

 
• By Anju Ghangurde

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
• By Vibha Ravi

Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

More from Business

Sanofi Cements RSV Dominance As Merck & Co. Rival Awaits FDA D-Day

 
• By Kevin Grogan

The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: Sanofi’s Blueprint buy; AstraZeneca’s breast cancer resistance results at ASCO; BMS and BioNTech’s big bispecific deal; Kymera’s Dupixent in a pill; and Degron’s CEO on pipeline and strategy.

Chinese Biotech VC/PE Fundings Rise But Still Modest

 
• By Dexter Jie Yan

LTZ Therapeutics and Beijing Sungen Biomedical are among the Chinese biotechs raising new funding, of around $40m each, based on their clinical assets with novel mechanisms of action. While fundings have risen, they remain moderate however.