The single-dose oral emergency contraceptive called Plan B One-Step (containing 1.5 mg of levonorgestrel) has been approved by the Food and Drug Administration (FDA) to be sold over the counter to all women and girls of child-bearing potential. There are no restrictions as to where or when the drug can be sold. The safety and efficacy of the drug were established previously.
Plan B One-Step is considered emergency contraception and is to be used in cases of unprotected sex or when a condom fails during intercourse. Plan B One-Step is most effective if taken within 72 hours after unprotected sex, but the sooner it's taken the better. Contraceptives like Plan B One-Step don't induce an abortion or cause injury to a fetus if the woman is pregnant already. Like all oral contraceptives, Plan B One-Step works to prevent ovulation and may also prevent implantation. And like all oral contraceptives, Plan B One-Step doesn't prevent the spread of sexually transmitted diseases, including HIV.
To put the news of this approval into context, some background information is helpful. The FDA refused to approve Plan B One-Step in December 2011 when the manufacturer had requested that the drug be made available over the counter without any age restriction. On April 5 of this year, a federal judge in New York ordered the FDA to allow over-the-counter (OTC) access, without age or point-of-sale restrictions, to both Plan B One-Step and the original Plan B, a two-dose, 0.75-mg levonorgestrel product currently sold without prescription but behind the counter to women 17 years of age or older and by prescription only to those younger than 17. Then, on April 30, the FDA approved an amended application submitted by the drug's manufacturer to allow the OTC sale of Plan B One-Step to women and girls as young as 15.
The FDA's June 20 approval of OTC use of Plan B One-Step in women and girls of all ages complies with the April 5 New York district court order. The U.S. Department of Justice, which had originally filed notice that it would appeal the judge's order, claiming that the court exceeded its authority, said in a June 10 letter that it would now comply with the court's ruling.
The government's actions fuel the ongoing debate over whether politics plays a greater role than science in decisions about the sale of emergency contraception. There has long been agreement in the medical community that these products can be used safely by women of all ages when it's sold over the counter.
At a joint meeting in 2003, two FDA entities, the Nonprescription Drugs Advisory Committee and the Reproductive Health Drugs Advisory Committee, voted overwhelmingly (23 to four) to approve Plan B as an OTC drug without age restrictions, changing it from a drug offered by prescription only. But when the FDA approved Plan B for OTC use in 2006, it didn't follow the recommendations of its joint committee, instead setting an age limitation for OTC sale at 18 years of age (modified in 2009 to 17 years) and maintaining the drug's prescription-only status for younger consumers. Causing further confusion, despite the June 20 approval for Plan B One-Step to be sold off the shelf without age restrictions, the original Plan B remains behind the counter and its sale to those younger than 17 is still by prescription only.
Plan B and Plan B One-Step contain the same amount of active drug. The two-dose Plan B regimen makes it somewhat more complicated to use than the single-dose Plan B One-Step. Nurses who work with sexually active female patients who are of reproductive age should provide education regarding the availability of these emergency contraceptives and how to use them.
To read the FDA news release regarding the approval, go to http://1.usa.gov/15GqdTS.