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FDA Approves 'Plan B' Pill for 17-Year-Olds
Date:4/22/2009

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.

More information

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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