OTC ban on `morning-after' pill defended

Possible effects on teen sex require study, FDA says

May 08, 2004|By Vicki Kemper | Vicki Kemper,LOS ANGELES TIMES

WASHINGTON - Dr. Steven Galson, acting director of the Food and Drug Administration's center for drug evaluation and research, said yesterday that politics played no role in his decision to require a doctor's prescription for the "morning-after" birth control pill.

Galson said he rejected his staff's recommendation for over-the-counter sales - as well as an advisory panel's 24-3 vote favoring nonprescription availability - out of concern that not enough was known about the possible effects of the pills on adolescent girls' sexual activity.

Bush administration officials outside the FDA did not influence the process, he said, adding that he was not aware of any White House meetings held to discuss the issue.

"I made the decision," he said yesterday during a news conference.

Galson said that after consulting with his staff and the FDA commissioner's office, he concluded that the agency did not have enough scientific information on whether easier access to emergency contraception would increase the rates of sexual activity - particularly unprotected intercourse - and sexually transmitted diseases among adolescent girls.

"From [ages] 11 to 14, where we know there are substantial amounts of sexual activity, there were no data in the application, and that really concerned me," Galson said.

Women's rights advocates and reproductive health groups continued yesterday to condemn the decision, which the FDA first communicated to Barr Laboratories, maker of the emergency contraceptive Plan B, late Thursday. Dr. Vivian M. Dickerson of the University of California, Irvine, the newly installed president of the American College of Obstetricians and Gynecologists, called the agency's action "morally repugnant" and said it ignored more than 15,000 pages of clinical data from about 40 scientific studies.

However, the U.S. Conference of Catholic Bishops praised the FDA's decision.

The Los Angeles Times is a Tribune Publishing newspaper.

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