Aug. 24, 2006 -- The FDA has approved Plan B, the so-called morning-after emergency contraceptive, to be sold without prescription to women age 18 and older.
Plan B's maker, Barr Pharmaceuticals, expects to introduce over-the-counter sales to women 18 and older by the end of the year.
To get Plan B, women will have to go to a pharmacy that has health care professionals on staff. The packages won't be in store aisles.
"Because Plan B will remain a prescription product for women 17 and younger, it will be sold in retail pharmacy outlets from behind the counter," Barr said, in a news release.
The drug company plans to work closely with pharmacies and wholesalers to make sure the age restriction is observed.
In a media teleconference, the FDA's Steven Galson, MD, MPH, explained why the age limit was set at age 18. "There are other prescription products, like nicotine replacement products, that require that age. And we thought for this program to practically work, the age 18 made sense. We didn't want to put in place a more complicated regime that might risk the program falling apart," he says. Galson directs the FDA's Center for Drug Evaluation and Research.
How to Use Plan B
There are nearly 3 million unintended pregnancies each year in the U.S., according to Barr, and Plan B could help prevent some of them.
Plan B should be taken as soon as possible after unprotected intercourse. When Plan B is taken within 72 hours of unprotected intercourse, studies show the risk of pregnancy decreases from 8% to 1%. The pill's effectiveness declines the longer a woman waits to use it; it is even more effective when taken in the first 24 hours after intercourse.
What Plan B Is and Isn't
Plan B is an emergency contraceptive. That means it's supposed to be used only as a backup plan when a couple has unprotected sex or when other contraceptive methods fail. Plan B should not be used as routine contraception and does not protect against HIV/AIDS and other sexually transmitted diseases (STDs).
Plan B is one of two approved emergency contraceptives. The other is Preven from Gynetics Inc. Gynetics has not asked for over-the-counter status, so today's FDA action applies only to Plan B.
If fertilization does occur, Plan B may prevent a fertilized egg from attaching the womb. If a fertilized egg is implanted prior totaking Plan B, it will not work and pregnancy proceeds normally.
Plan B is not the same as RU-486, the so-called "abortion pill," which causes a chemical abortion after pregnancy occurs.
Path to Over-the-Counter Approval
Plan B has been available by prescription to women of any age since 1999. Its maker, Barr Pharmaceuticals, has long sought FDA approval to market Plan B available over the counter.
In April 2003, Barr applied to market Plan B an over-the-counter drug. In December 2003, an FDA advisory committee met to discuss Barr's application.
The committee backed Barr's application. But the FDA decided it needed more information about how Plan B could be safely used by adolescents without supervision by a licensed practitioner.
In March 2004, Barr submitted another application, this time limiting Plan B's over-the-counter sales to women at least 16 years old.
In May 2004, the FDA declined to complete its review of that application, calling Barr's proposal "preliminary and incomplete."
Barr subsequently submitted more information in support of its application. In August 2005, the FDA again delayed a decision.
Lester M. Crawford, DVM, was FDA commissioner at the time. He issued a statement on Aug. 26, 2005 citing "unresolved regulatory and policy issues" as the reason for the delay.
In his statement, Crawford noted that the FDA had concluded "the available scientific data are sufficient to support the safe use of Plan B as an over-the-counter product, but only for women who are 17 years of age or older."