Decision is latest involving controversial birth-control drug
WEDNESDAY, April 22 (HealthDay News) -- Responding to a federal judge's directive, the U.S. Food and Drug Administration said Wednesday that it will now allow 17-year-olds to get the controversial "morning-after" birth control pill without a doctor's prescription.
In 2006, the FDA said it would limit over-the-counter access to the pill, also known as Plan B, to women 18 and older. But U.S. District Judge Edward R. Korman ruled last month in a New York lawsuit that the FDA had to reconsider whether to make the drug available to all women, regardless of age, without a prescription. He ordered the agency to let 17-year-olds get the drug, and separately to evaluate whether all age restrictions should be lifted.
"On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription," the agency said in a statement issued Wednesday afternoon on its Web site. "The government will not appeal this decision. In accordance with the court's order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older."
Plan B is an extra high dose of regular birth control that needs to be taken within 72 hours of unprotected intercourse to be effective. Essentially, the drug prevents pregnancy by delaying ovulation. It does not interrupt an already implanted pregnancy.
Religious conservatives object to Plan B, saying it is the equivalent of an abortion pill because it can prevent a fertilized egg from attaching to the uterus, and could also encourage premarital sex.
Supporters of broader access to Plan B argue that it is safe and effective in preventing unwanted pregnancy, and could also help reduce the number of abortions. They also contend that the FDA's decision to limit access to the drug to women 18 and older was a concession to the conservative views of then-President George W. Bush and his administration.
When the FDA announced its approval of over-the-counter sale of the Plan B pill in August 2006, after three years of delay, the decision came with stiff restrictions: Women under the age of 18 could not purchase the pills without a doctor's prescription.
"Our assessment is that this younger age group would strongly benefit from consultation with a health-care provider before using the product," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said during a 2006 news conference. "The application did not contain enough information about this age group to make us comfortable to do the switch fully for those younger people."
The age restriction was also meant to ease concerns for pharmacists, Galson said. "We have all kinds of restrictions that click in at 18," he said. "We thought for this program to practically work, the age 18 made sense."
The FDA originally approved Plan B as a prescription drug in 1999. It is manufactured by Duramed Research Inc. of Bala Cynwyd, Pa.
For more on Plan B, visit the FDA.
SOURCES: April 22, 2009, news release, U.S. Food and Drug Administration; Aug. 24, 2006, news conference with Steven Galson, M.D., director, U.S. Food and Drug Administration Center for Drug Evaluation and Research
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