'Morning After' Pill Judge Slams Feds for 'Nonsense' Age Restrictions

Orders FDA To Lift Rules for 'Plan B' Pill

By Reuters

Published May 07, 2013.
  • Print
  • Share Share

A federal judge criticized the U.S. Food and Drug Administration over its refusal to make emergency contraception available to girls of all ages without a prescription, saying the agency’s move to restrict distribution to consumers aged 15 and older was not realistic.

U.S. District Judge Edward Korman on April 5 ordered the FDA to lift age restrictions on all levonorgestrel-based emergency contraception - also known as the “morning-after” pill or “Plan B” - to prevent unwanted pregnancies.

At a hearing in Brooklyn, New York, on Tuesday, he said he would rule by the end of the week on the FDA’s request to stay the order, which is slated to take effect May 10. The FDA has appealed the ruling to the 2nd U.S. Circuit Court of Appeals in Manhattan.

“I do think there is a principle that is a dangerous one of a court ordering the FDA to approve a drug,” FDA Commissioner Margaret Hamburg told the Reuters Health Summit in New York on Monday ahead of the hearing. “You have to step back and look at this not just in terms of Plan B but in terms of the precedent.”

Late last month, the FDA said it would allow girls as young as 15 years old to buy Plan B One-Step contraception, made by a unit of Teva Pharmaceutical Industries Ltd, without a prescription. Cashiers will still have to verify the customer’s age before selling it. The agency said the move was based on data provided by Teva that showed girls of that age could safely use the drug without the intervention of a healthcare provider.

Korman called the decision “a lot of nonsense,” saying that 15- and 16-year-olds may not have photo identification needed to buy the drug.

The judge noted that the FDA’s restrictions still apply to other forms of emergency contraception, including a two-pill version of Plan B and its generic equivalents. These are only available to women 17 and older with identification.

Korman also questioned the timing of the decision, made one day before the FDA filed its notice of appeal of the April order.

“I’m convinced the only reason you decided it when it was decided was to sugarcoat this appeal,” Korman told a lawyer for the FDA, Farzin Franklin Amanat.

A lawyer for the plaintiffs, Janet Crepps of the Center for Reproductive Rights, countered that the different access rules for Plan B One-Step and other forms of emergency contraception had created a “convoluted” system for girls and women seeking the drug in its brand name and generic forms.

“That’s what happens when you let politicians instead of scientists make these decisions,” Korman replied.

Emergency contraceptives generally sell for $10 to $80. Although they can work as long as 120 hours after unprotected sex, they are most effective in the first 24 hours.

Asked about the ongoing court case, Teva Chief Executive Jeremy Levin said the company provides medicines where they are needed.

“I’m not interested in getting into politics,” he told the Reuters Health Summit. “The bottom line is that we believe we are providing an important medicine.”


The Jewish Daily Forward welcomes reader comments in order to promote thoughtful discussion on issues of importance to the Jewish community. In the interest of maintaining a civil forum, The Jewish Daily Forwardrequires that all commenters be appropriately respectful toward our writers, other commenters and the subjects of the articles. Vigorous debate and reasoned critique are welcome; name-calling and personal invective are not. While we generally do not seek to edit or actively moderate comments, our spam filter prevents most links and certain key words from being posted and The Jewish Daily Forward reserves the right to remove comments for any reason.





Find us on Facebook!
  • Is pot kosher for Passover. The rabbis say no, especially for Ashkenazi Jews. And it doesn't matter if its the unofficial Pot Day of April 20.
  • A Ukrainian rabbi says he thinks the leaflets ordering Jews in restive Donetsk to 'register' were a hoax. But the disturbing story still won't die.
  • Some snacks to help you get through the second half of Passover.
  • You wouldn't think that a Soviet-Jewish immigrant would find much in common with Gabriel Garcia Marquez. But the famed novelist once helped one man find his first love. http://jd.fo/f3JiS
  • Can you relate?
  • The Forverts' "Bintel Brief" advice column ran for more than 65 years. Now it's getting a second life — as a cartoon.
  • Half of this Hillel's members believe Jesus was the Messiah.
  • Vinyl isn't just for hipsters and hippies. Israeli photographer Eilan Paz documents the most astonishing record collections from around the world:http://jd.fo/g3IyM
  • Could Spider-Man be Jewish? Andrew Garfield thinks so.
  • Most tasteless video ever? A new video shows Jesus Christ dying at Auschwitz.
  • "It’s the smell that hits me first — musty, almost sweet, emanating from the green felt that cradles each piece of silver cutlery in its own place." Only one week left to submit! Tell us the story of your family's Jewish heirloom.
  • Mazel tov to Chelsea Clinton and Marc Mezvinsky!
  • If it's true, it's pretty terrifying news.
  • “My mom went to cook at the White House and all I got was this tiny piece of leftover raspberry ganache."
  • from-cache

Would you like to receive updates about new stories?




















We will not share your e-mail address or other personal information.

Already subscribed? Manage your subscription.