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 Ltd without a prescription.

What is emergency contraception?

There are three types of emergency contraception now available to women. These are two types of pill, and the intrauterine contraceptive device (IUCD) - also called the coil. They are available from your GP practice, NHS walk-in centres, family planning organisations and pharmacies.

Emergency contraception can be used:

  If you have had sex without using contraception.
  If you have had sex, but there was a mistake with contraception. For example, a split condom or if you forgot to take your usual contraceptive pills.

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.

Emergency contraception—also called postcoital contraception—is a form of birth control that may be used by women who have had unprotected sex or used a contraceptive method that failed. The treatment generally is reserved for emergency situations and is not a regular method of birth control. Emergencies include being raped, having a condom break or slip off during sex, missing two or more birth control pills during a monthly cycle, and having unplanned sex. Emergency contraception is not a form of abortion; it is used to prevent a pregnancy, not end one. Emergency contraception does not protect against sexually transmitted diseases. It is not RU-466, the medication used to induce abortions.

Plan B One-Step is a specifically packaged emergency contraception.

  If you are 17 or older, you can get Plan B from a pharmacist, without a prescription. Bring proof of your age.
  If you are younger than 17, you can get Plan B with a prescription from a doctor.

Ella is a non-hormonal pill. It contains ulipristal, a non-hormonal drug that blocks the effects of key hormones necessary for conception. It is available only by prescription.

Plan B One-Step emergency contraception may prevent pregnancy by temporarily blocking eggs from being produced, by stopping fertilization, or by keeping a fertilized egg from becoming implanted in the uterus. Plan B One-Step is taken in one dose with one pill. Its effectiveness depends on how soon you take the Plan B pill. It should be taken as soon as possible—within 72 hours of unprotected intercourse. When Plan B is taken as directed, it can reduce the chance of pregnancy by close to 90%.

Ella can be taken up to 120 hours after sex. It is taken as one tablet in one dose. 

An IUD can be inserted to prevent pregnancy within five to seven days after unprotected intercourse.

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

FDA and Teva officials declined to comment.


By Jessica Dye

Provided by ArmMed Media