'Morning-after' pill headed over-the-counter?

By Leslie Wade
CNN Medical Producer

WASHINGTON (CNN) -- The makers of the emergency contraception product Plan B will meet with the Food and Drug Administration Monday to discuss changing the drug's status from prescription to over-the-counter. Plan B, often called the "morning-after pill," can prevent women from becoming pregnant in case of contraceptive failure or unprotected sex.

Representatives from the Women's Capital Corporation, which makes Plan B, will propose two safety studies. The FDA is expected to make a decision on the proposals Monday. Study results would be submitted to the FDA upon completion in early 2002. A status change for the drug could take place in mid- to late 2002.

Emergency contraception is currently available only through clinics such as Planned Parenthood or with a doctor's prescription. Women are prescribed two pills, the first taken within three days of sexual intercourse and the second taken 12 hours later.

Reaching a doctor, filling the prescription, or getting to a family planning clinic within this 72-hour window is not always possible. Doctors say if emergency contraception becomes available over-the-counter, the convenience would increase a woman's chances of preventing pregnancy. It typically reduces the likelihood of pregnancy by more than 75 percent.

Although emergency contraceptive pills (ECP) have been around for more than 25 years, it was not until the late 1990s that two dedicated ECPs, Plan B and Preven, came onto the U.S. market. Prior to that doctors prescribed a little-known regimen of several birth control pills to serve as emergency contraception.

Emergency contraceptive pills are often confused with RU-486, also known as the abortion pill. It is taken by pregnant women to end a pregnancy early, while ECPs help prevent a pregnancy from occurring. If a pregnancy is already established the morning-after pill will have no effect.

Experts say widespread use of emergency contraception in the U.S. could prevent up to 1.5 million unintended pregnancies and 700,000 abortions each year. During a pilot project in Washington, from March 1998 through June 1999, almost 12,000 ECP prescriptions were provided. The study estimated the ECP use prevented approximately 677 unwanted pregnancies, about half of which would have ended in abortion.

During the study, pharmacists were able to prescribe ECPs without the supervision of doctors -- women could come directly to the pharmacist and request the product.

RU-486 nod ushers new era of abortion debate
September 29, 2000
Male contraceptive pill on the horizon?
September 8, 2000
FDA approves first emergency contraceptive kit
September 2, 1998
FDA approval of abortion pill linked to stringent conditions
June 7, 2000

Consumer's Guide to 'Plan B'
Planned Parenthood
U.S. Food and Drug Administration

Note: Pages will open in a new browser window

External sites are not endorsed by CNN Interactive.