FDA Drug Chief Says He Made ‘Morning After’ Pill Decision

Dr. Steven Galson, acting director of the Food and Drug Administration’s center for drug evaluation and research, said Friday 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 23-4 vote favoring nonprescription availability -- out of concern that not enough was known about the possible effects of the pills on the sexual activity of young girls.

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 Friday 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 Friday 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 UC 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 some 40 scientific studies.

However, the U.S. Conference of Catholic Bishops, noting that the drug sometimes works after conception by preventing a fertilized egg from implanting in a woman’s womb, praised the FDA’s decision.

“The Plan B distributor may argue that it’s all the same, but preventing human life from beginning is not the same thing as destroying life that has already begun,” said Cathy Cleaver Ruse, planning director of the conference’s Secretariat for Pro-Life Activities. “A drug which can destroy human embryos and increases health risks to women and girls does not belong on the drugstore shelf.”

In rejecting Barr’s application, the FDA said the manufacturer could get another shot at over-the-counter status by submitting information demonstrating Plan B could be used safely by girls younger than 16 without a doctor’s guidance or by agreeing to limit over-the-counter availability to those 16 and older.

“We’re not shutting the door on it,” Galson said. A reapplication process is expected to take at least several months.

The FDA approved Preven, another emergency contraceptive, as a prescription-only drug in 1998; Plan B was approved a year later. The drugs, which contain higher doses of the hormones that are in once-a-day birth control pills, are up to 89% effective in preventing pregnancy when taken within 72 hours of unprotected sex.

Those who support making Plan B available without a prescription continued to insist Friday that the White House was behind the FDA’s decision. Elizabeth A. Cavendish, interim president of NARAL Pro-Choice America, said her group was sending e-mail alerts to about 400,000 activists encouraging them to send “a prescription to President Bush to tell him to take a dose of reality. American women are pro-family planning.”

Thirty-three nations allow the sales of emergency contraception without a prescription.

Galson’s concerns about the ready availability of the morning-after pill echoed those raised in a letter that 49 members of Congress sent to Bush in January, urging him to reject over-the-counter status for Plan B.

In that letter and in subsequent statements, Rep. Dave Weldon (R-Fla.) said that “since adolescents are most vulnerable” to sexually transmitted diseases, easier access to the morning-after pill could lead to increased rates of promiscuity and disease among teens.

Cavendish disputed that assertion, citing a study this year in the Journal of Pediatric and Adolescent Gynecology that examined the sexual behavior of 301 predominately minority, low-income, sexually active women ages 15 to 20 who had not been using long-term contraception. It concluded that providing emergency contraception to the women was “not associated with more unprotected intercourse or less condom or hormonal contraception use.”

Proponents of easier access to the drug said that by preventing unwanted pregnancies, it also would reduce the number of abortions by as many as hundreds of thousands a year.