1. Pink Sheet
  2. >>Legislation

New Attack Against FDA’s Mifepristone Approval Targets Potential Water Contamination

 
• By Brenda Sandburg

Students for Life of America requests that FDA revoke approval of mifepristone and REMS changes, claiming the agency failed to determine the medication abortion drug would not pollute waterways. The group’s fourth citizen petition follows similar claim that the agency failed to comply with the Endangered Species Act.

Drug pollution
Mifepristone's potential contamination of waterways was not assessed by FDA prior to drug's approval, antiabortion group claims • Source: Shutterstock

As the legal battle continues over the US Food and Drug Administration’s approval of mifepristone, the group Students for Life of America is pursuing novel claims in a quest to get the drug taken off the market.

The group filed a 1 August citizen petition requesting that the FDA revoke approval of the medication abortion drug...

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 Legislation

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

EU Ups Ante On Stockpiling For Crises

 
• By Francesca Bruce

The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.

Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 
• By Sarah Karlin-Smith

US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.

EU Medical Countermeasures Strategy Promises More AMR Pull Incentives

 
• By Francesca Bruce

A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.

More from Pink Sheet

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.

England Leads Europe In Reimbursing Vertex’s Next-In-Class CF Drug Alyftrek

 
• By Neena Brizmohun

Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.