'Morning after' pill to stay prescription-only for girls under 17
Makers of Plan B One-Step had asked the FDA to make the drug available over the counter to all sexually active girls and women.
December 7th, 2011
10:57 PM ET

'Morning after' pill to stay prescription-only for girls under 17

The secretary of Health and Human Services overruled Wednesday a Food and Drug Administration recommendation that would have made the emergency contraceptive pill Plan B One-Step available over the counter to girls younger than 17.

In February, Teva Woman's Health Inc, the drug maker, had asked the FDA to make the drug available without prescription to all sexually active girls and women.

At the time, FDA Commissioner Dr. Margaret Hamburg said that, after reviewing all relevant data, "Plan B One Step is safe and effective and should be approved for non-prescription use for all females of child-bearing potential."

But HHS Secretary Kathleen Sebelius overruled that recommendation. "Because I do not believe enough data were presented to support the application ... I have directed FDA to issue a complete response letter denying the supplemental new drug application," she said in a statement.

In July 2009, Plan B was approved for use without a prescription for females aged 17 and older, but girls under 17 needed a prescription.

Emergency contraceptives prevent a pregnancy by preventing a fertilized egg from embedding in the uterus. They are intended for use within 72 hours after sex, but are most effective if taken within 24 hours. Proponents say requiring a prescription can delay access to the drug.

Wednesday's decision was criticized by the American Society for Reproductive Medicine, which counts more than 8,000 members.

"We are very disappointed that Secretary Sebelius opted to insert herself into what should be a scientific decision made by the experts at FDA," said the group's president, Dolores J. Lamb. "The data are clear that emergency contraception can be safely used by adolescent women without requiring a prescription. Sadly, it appears that once again our leaders are putting political expediency ahead of reproductive health."

But Dr. Lisa Flowers, associate professor in the Department of Obstetrics and Gynecology at Emory University's School of Medicine, said Sebelius' decision "might be the right thing to do until we get a really good system by which we can educate young kids about prevention of pregnancy and understanding the risks of getting involved in sexual intercourse, and what are the outcomes."

Flowers suggested the FDA consider allowing over-the-counter access for girls under the age of 17 if they are accompanied by a parent to the drugstore.


Filed under: Abortion • Health • Health Care
soundoff (30 Responses)
  1. banasy©

    What is to prevent them from getting an 18 year old female friend to buy it?

    December 7, 2011 at 11:20 pm | Report abuse |
  2. RUFFNUTT (pit bull trainer)

    IN DAYS OF OLD
    WHEN KNIGHT WERE BOLD
    and rub-bers wern't invented
    men wrapped there socks
    around thier c0cks
    and babies were prevented

    December 7, 2011 at 11:30 pm | Report abuse |
  3. bobcat (in a hat)

    That was my thought exactly.

    December 7, 2011 at 11:30 pm | Report abuse |
  4. RUFFNUTT (pit bull trainer)

    @banasy... exactlly

    December 7, 2011 at 11:31 pm | Report abuse |
  5. bobcat (in a hat)

    Another thing too. Instead of an abortion pill, if parents wouldn't be so shy about talking to their daughters about birth control, a lot of this day after worry could be prevented. Face it, some kids are going to get active no matter what you say. Better to make the preemptive move.

    December 7, 2011 at 11:37 pm | Report abuse |
  6. Mourning After

    We tried 'morning after'. You know...coyote ugly. When she's so ugly, you chew your arm afff so as not to sidturb her when you sneak away next morning. Not to mention "ALIEN" flying saucers.

    December 8, 2011 at 12:21 am | Report abuse |
  7. Mourning After

    translate at will.

    December 8, 2011 at 12:23 am | Report abuse |
  8. Jeff Frank (R-Ohio) "Right Wing Insanity"

    Protection exclusivly for jailbait....imagine that. 😉

    December 8, 2011 at 12:32 am | Report abuse |
  9. banasy©

    Ruffie and bobcat:
    Please report the abuse on the troll crissy's posts, will ya?
    Too late for me to contact my CNN buddy.

    December 8, 2011 at 12:32 am | Report abuse |
  10. banasy©

    You, too, please, jeff...

    December 8, 2011 at 12:33 am | Report abuse |
  11. Jeff Frank (R-Ohio) "Right Wing Insanity"

    She told me Monday, I think it was someone was making fun of her son. You got my help banasy.

    December 8, 2011 at 12:39 am | Report abuse |
  12. banasy©

    Thanks, Jeff.
    I have no report abuse button on my phone. Stinks!

    December 8, 2011 at 12:44 am | Report abuse |
  13. Jeff Frank (R-Ohio) "Right Wing Insanity"

    It's getting to the point now, the FBI's Cyber Crimes Div. "will be duly notified".

    December 8, 2011 at 12:44 am | Report abuse |
  14. Jeff Frank (R-Ohio) "Right Wing Insanity"

    Point to the time of post banasy, I do have the button on my Opera browser on my phone...

    December 8, 2011 at 12:48 am | Report abuse |
  15. banasy©

    @Jeff:
    I have it on pretty good authority that they already know.
    I also have a CNN buddy, too.
    We shall overcome!

    😉

    December 8, 2011 at 12:49 am | Report abuse |
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