REMS In The Time Of COVID-19: ACLU Sues FDA Over Abortion Pill Access

Medical and advocacy groups claim FDA is requiring women to fill prescriptions for Mifeprex in person while waiving REMS requirement for in-person visits for other drugs.

Abortion pill, unwanted pregnancy
Medical groups sue FDA to temporarily halt REMS requirement for abortion pill mifepristone

Medical organizations claim that the US Food and Drug Administration is restricting access to the abortion pill Mifeprex (mifepristone) by requiring patients to pick it up in-person at a clinic or medical office as required under the product's Risk Evaluation and Mitigation Strategy. They say the FDA has waived REMS enforcement for other drugs requiring in-person visits during the COVID-19 pandemic and the same policy should apply to mifepristone.

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

More from US FDA

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By 

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
• By 

Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.

US FDA Staff’s Union President Calls For More Support From Industry

 

Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.

HHS’ Kennedy Warns US FDA Staff Against ‘Agency Capture’ By Industry, Special Interests

 
• By 

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.

More from Agency Leadership

AMR-Targeting Drug Secures EMA PRIME Designation

 

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say

 

The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.