'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!
  • “Look, on the one hand, I understand him,” says Rivka Ben-Pazi, a niece of Elchanan Hameiri, the boy that Henk Zanoli saved. “He had a family tragedy.” But on the other hand, she said, “I think he was wrong.” What do you think?
  • How about a side of Hitler with your spaghetti?
  • Why "Be fruitful and multiply" isn't as simple as it seems:
  • William Schabas may be the least of Israel's problems.
  • You've heard of the #IceBucketChallenge, but Forward publisher Sam Norich has something better: a #SoupBucketChallenge (complete with matzo balls!) Jon Stewart, Sarah Silverman & David Remnick, you have 24 hours!
  • Did Hamas just take credit for kidnapping the three Israeli teens?
  • "We know what it means to be in the headlines. We know what it feels like when the world sits idly by and watches the news from the luxury of their living room couches. We know the pain of silence. We know the agony of inaction."
  • When YA romance becomes "Hasidsploitation":
  • "I am wrapping up the summer with a beach vacation with my non-Jewish in-laws. They’re good people and real leftists who try to live the values they preach. This was a quality I admired, until the latest war in Gaza. Now they are adamant that American Jews need to take more responsibility for the deaths in Gaza. They are educated people who understand the political complexity, but I don’t think they get the emotional complexity of being an American Jew who is capable of criticizing Israel but still feels a deep connection to it. How can I get this across to them?"
  • “'I made a new friend,' my son told his grandfather later that day. 'I don’t know her name, but she was very nice. We met on the bus.' Welcome to Israel."
  • A Jewish female sword swallower. It's as cool as it sounds (and looks)!
  • Why did David Menachem Gordon join the IDF? In his own words: "The Israel Defense Forces is an army that fights for her nation’s survival and the absence of its warriors equals destruction from numerous regional foes. America is not quite under the threat of total annihilation… Simply put, I felt I was needed more in Israel than in the United States."
  • Leonard Fein's most enduring legacy may be his rejection of dualism: the idea that Jews must choose between assertiveness and compassion, between tribalism and universalism. Steven M. Cohen remembers a great Jewish progressive:
  • BREAKING: Missing lone soldier David Menachem Gordon has been found dead in central Israel. The Ohio native was 21 years old.
  • “They think they can slap on an Amish hat and a long black robe, and they’ve created a Hasid." What do you think of Hollywood's portrayal of Hasidic Jews?
  • 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.