10.05.2013 • News

Judge Denies FDA Bid to Stay 'Morning-after' Pill Ruling

A federal judge in New York on Friday declined to temporarily halt a court order directing the U.S. Food and Drug Administration to make emergency contraception available over the counter to girls of all ages.

However, U.S. District Judge Edward Korman in Brooklyn said he would give the FDA until May 13 to ask a federal appeals court in Manhattan to stay the order, which had been scheduled to take effect on Friday.

Korman ordered the FDA on April 5 to lift age and point-of-access restrictions on all levonorgestrel-based emergency contraception, also known as the "morning-after" pill or "Plan B," to prevent unwanted pregnancies. The FDA has appealed that ruling.

"In my view, the defendants' appeal is frivolous and taken for the purposes of delay," Korman wrote in Friday's decision.

The case stems from a 2005 lawsuit filed by a coalition of reproductive rights advocates who sought to lift age and access restrictions on emergency contraception.

At the time of Korman's original April ruling, emergency contraception was available without a prescription to women 17 years and older who presented identification at a pharmacist's counter.

Late last month, the FDA said it would allow girls as young as 15 to buy a one-pill version of emergency contraception, Plan B One-Step, made by a unit of Teva Pharmaceutical Industries without a prescription.

The agency said its decision was unrelated to the court ruling and based on data from Teva showing teens that age could take the drug safely.

In the April 5 ruling, Korman called the agency's restrictions on emergency contraception "arbitrary, capricious and unreasonable," and gave it 30 days to make the drug available over the counter to women of all ages.

If taken up to 120 hours after unprotected sex, emergency contraception is designed to prevent pregnancy.

FDA and Teva officials declined to comment.

 

From Lab to Market Challenge

Vote Now: Germany's Most Promising Chemistry Start-ups
Choose your favourite among the finalists

Vote Now: Germany's Most Promising Chemistry Start-ups

The "From Lab to Market Challenge" brings together the most promising founders from chemistry, materials science, and industrial biotechnology. Starting June 1st, you can cast your public vote for the finalists on CHEManager.com — before the award ceremony with €10,000 in prizes takes place on June 25th.

Expert Insights

ADCs for Precision Cancer Therapy
Comprehensive Insights into Antibody–Drug Conjugates

ADCs for Precision Cancer Therapy

Explore how antibody-drug conjugates are reshaping precision cancer therapy and discover what it takes to successfully develop, manufacture, and scale these complex biologics.

most read