After three years of delay, the US Food A and Drug Administration (FDA) has approved the over-the-counter (OTC) sale of the emergency contraceptive Plan B, sometimes called the morning-after pill. However, the drug can only be dispensed over-the-counter by a licensed pharmacist.
The pill is an extra-high dose of regular birth control that is effective only if it is taken within 72 hours of unprotected intercourse. The drug prevents pregnancy by delaying ovulation, but it does not interrupt an already-implanted pregnancy.
"Emergency contraception is a method of preventing pregnancy after contraceptive fails or after unprotected sex," explains Dr. Steven Galson, director of the FDAs Center for Drug Evaluation and Research. "Plan B acts primarily by stopping the release of an egg from the ovary. It's important to note that Plan B is not intended for routine use. It's an emergency contraception."
Although approved, the approval was accompanied by the restriction that women younger than age 18 cannot purchase the pills without a doctor's prescription. This condition was set to respond to the concerns of conservative groups that said the contraceptive's easy availability would encourage premarital sex.
"Our assessment is that this younger age group would strongly benefit from consultation with a health-care provider before using the product," says Galson. "The application [for approval] did not contain enough information about this age group to make us comfortable to do the switch fully for those younger people."
Background On The Controversy
The announcement "concludes an extensive process that included getting expert advice from two of the FDAs advisory committees , and [allowing] an opportunity for public comment," according to Galson.
The FDA originally approved Plan B as a prescription drug in 1999. In 2001, more than 60 health groups petitioned the US government to make emergency contraceptives available without a prescription. In December 2003, the FDA advisory committees concluded that Plan B was both safe and effective. They overwhelmingly recommended that the agency make Plan B available without a prescription.
But in an unusual move, the FDA ignored the advice of the committees, and delayed making its decision.
Soon after, the FDA added another condition for approval, informing Barr Pharmaceuticals, the drug's manufacturer, that the morning-after pill could not be sold OTC until more studies were done. The FDA denied that this move was politically motivated, and said it arose from concern that teenage girls would not be able to use the product safely.
Reaction from groups that advocate the OTC sale of this contraception was swift in coming.
"The American Society for Reproductive Medicine [ASRM] is pleased that the FDA has approved making emergency contraception available to women age 18 and over" says ASRM President Dr. Joseph S. Sanfilippo. "We are encouraged that the FDA has heeded the advice of its Reproductive Health Drugs Advisory Committee and the Over-the-Counter Advisory Committee, and has recognized that the morning-after pill is a safe and effective way to protect against pregnancy in an emergency."
However, other supporters of Plan B, such as Planned Parenthood, say the FDAs decision to require age restrictions will hamper efforts to reduce the nation's 3 million annual unplanned pregnancies, and consequently, the number of abortions.
"While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers," says Cecile Richards, president of Planned Parenthood. "The US has one of the highest rates of teen pregnancy in the Western world. Anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy."
Plan B opponents fear that requiring a doctor's prescription for women younger than 18 will do little to limit teen promiscuity.
"If the FDA thinks that enacting an age restriction will work, or that the drug company will enforce it...then they are living in a dream world," says Wendy Wright, president of Concerned -Women for America, which led the opposition to the contraceptive.