Morning-After Pill Is Over the Counter
FDA OKs 'Plan B' to Be Sold Without Prescription to Women 18 and Older
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
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.
Plan B works like other birth control pills to
prevent pregnancy. Plan B acts primary by stopping the release of an egg from
the ovary. It may prevent a sperm from fertilizing the egg.
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.