Members of Congress Ask FDA to Reconsider Morning After Pill Decision

National   |   Steven Ertelt   |   May 13, 2004   |   9:00AM   |   WASHINGTON, DC

Members of Congress Ask FDA to Reconsider Morning After Pill Decision

by Steven Ertelt Editor
May 13, 2004

Washington, DC ( — Forty-one members of Congress have signed off on a letter to acting FDA Commissioner Lester Crawford asking him and the federal drug agency to reevaluate their decision to deny an application by Barr Laboratories to sell the controversial "morning after" pill over the counter.

The representatives charged the agency with putting politics ahead of science and called for top officials to resign.

Pro-life groups praised the agency’s decision last week saying that it will protect teens and allow physicians to help women make better choices. The drug can sometimes act as an abortion agent to destroy the life of a unique human being moments after conception.

The FDA denied Barr’s request because the pharmaceutical company failed to provide enough data about the impact of the drug on teens.

The agency said Barr’s main basis for approval was a study of 585 people who had used the drug. However, the FDA pointed out that only 29 of the subjects were 14-16 years old.

The agency’s decision was atypical because it disagreed with the recommendation of an advisory panel that voted 23-4 in December in favor of sales with a prescription. Also, Steven Galson, acting director of FDA’s Center for Drug Evaluation and Research, said he made the decision himself to deny the application over the objections of the panel and other FDA staff.

Twelve House members, including Rep. Louise Slaughter (D-NY), called for Crawford and Galson to step down and said she wants the non-partisan General Accounting Office "to investigate the serious allegations that the FDA allowed political considerations to affect its decision."

"The FDA’s decision to ignore its own scientific advisory and its own staff clearly demonstrates that the leadership would rather pander to conservative interests than protect women’s health and well-being," Slaughter said at a news conference.

Planned Parenthood, NOW and the pro-abortion National Women’s Law Center joined Slaughter at yesterday’s press conference.

Meanwhile, Rep. Carolyn B. Maloney (D-NY), another abortion advocate, said she would introduce legislation that would require the agency to review its decision and confirm that it was a science-based rather than a politicial one.

Peter Pitts, FDA associate commissioner for external relations, told Reuters that the agency stands by the decision.

Pitts pointed to the letter the FDA sent Barr Labs showing the drug company how it could get the drug approved for over-the-counter sales. "We presented to Barr a bright path forward to approval," he said.

The FDA said Barr could resubmit the application with a caveat that customers purchasing the drug must be at least 16 years-old. Younger women would need a doctors’ order to be able to buy the pills.

Barr chief executive Bruce Downey confirmed that his company would do that.

Pro-life groups hailed the agency’s decision as a victory for women and teenagers.

"A drug which can destroy human embryos and increases health risks to women and girls does not belong on the drugstore shelf," Cathy Cleaver Ruse, of the United States Conference of Catholic Bishops, said.

Ruse said the morning after pill has been associated with a heightened risk of ectopic pregnancy, a potentially fatal condition. Medical authorities in the U.K. and New Zealand have issued warnings about the drug’s dangers.