FDA keeps access limited to Plan B morning-after pill
Key points
- U.S. drug regulators kept the controversial morning-after pill behind the pharmacy counter as they denied the drugmaker's request to drop the age limit on who can buy the emergency contraceptive without a prescription.
- Health and Human Services Secretary Kathleen Sebelius on Wednesday directed the Food and Drug Administration to keep the prescription requirement for girls younger than 17.
- She said the pill's maker, Teva Pharmaceutical Industries Ltd, did not present enough evidence to show that younger girls would properly understand and use the pill, made to prevent unwanted pregnancies, without talking to a doctor first.
- Although FDA Commissioner Margaret Hamburg signaled that she planned to approve Teva's request, Sebelius's disagreement led her to leave access to Teva's Plan B One-Step limited.
U.S. drug regulators kept the controversial morning-after pill behind the pharmacy counter as they denied the drugmaker's request to drop the age limit on who can buy the emergency contraceptive without a prescription.
Health and Human Services Secretary Kathleen Sebelius on Wednesday directed the Food and Drug Administration to keep the prescription requirement for girls younger than 17.
She said the pill's maker, Teva Pharmaceutical Industries Ltd, did not present enough evidence to show that younger girls would properly understand and use the pill, made to prevent unwanted pregnancies, without talking to a doctor first.
Although FDA Commissioner Margaret Hamburg signaled that she planned to approve Teva's request, Sebelius's disagreement led her to leave access to Teva's Plan B One-Step limited.
The pill, which has to be taken within 72 hours of unprotected sexual intercourse, has technically been an over-the-counter drug, but only for women over 17. With younger girls requiring a prescription, buying Plan B has required showing a pharmacist identification for an age check.
(Reporting by Alina Selyukh in Washington)
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(Reuters) -
Written and revised by
Andrey Nailor, M.D.
Our doctors write and review articles for accuracy and keep them up to date.
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