The U.S. Court of Appeals for the D.C. Circuit ruled June 2 that the Food and Drug Administration (FDA) failed to adequately explain why it withheld more than 6,000 documents pertaining to the dangerous abortion drug RU-486 under a Freedom of Information Act request by the watch-dog group Judicial Watch.

The court returned the case to the U.S District Court for the District of Columbia for further review and ordered the FDA to provide more information about the documents withheld.

The court's decision highlights the ongoing controversy surrounding the fast-tracked approval of RU-486, a drug that has killed at least eight women and injured hundreds more. A special report released in May by Judicial Watch, titled, "The Clinton RU-486 Files," revealed President Bill Clinton's legal, political and press strategy for ensuring approval of the dangerous drug.

Clinton's first official act in office was to order the Department of Health and Human Services (HHS) and the FDA to coordinate the marketing of RU-486. In one confidential memo, former HHS Secretary Donna Shalala bragged that she and former FDA Commissioner David Kessler personally convinced the makers of RU-486 to market the abortion pill in the United States.

In response to the mounting concern over the deadly drug, the FDA held a conference in May to study the bacterium, known as Clostridium sordellii, related to the RU-486 deaths. C. sordellii has been linked to four RU-486 deaths in California and one in Canada since 2000. In each case, the women took RU-486 in combination with another drug, misoprostol. Yet the scientists at the FDA conference reached no consensus as to whether RU-486 played any role in the deaths of the California women.

Wendy Wright, President of Concerned Women for America, said that the FDA has a "lower standard when it comes to women's health. ... Death seems to be an acceptable complication when dealing with abortion."

Through March 31, the FDA has received reports of 950 serious side effects after the use of RU-486, including nine life-threatening incidents, 232 hospitalizations, 116 cases of heavy bleeding that required transfusions, and 88 infections.

Frustrated with the FDA's refusal to take action, Congress held a hearing, led by Rep. Mark Souder (R-Indiana), chairman of the Criminal Justice, Drug Policy and Human Resources Subcommittee, to study the safety of RU-486. In addition, Rep. Roscoe Bartlett (R-Maryland) has introduced Holly's Law, a bill that would require the FDA to immediately suspend its approval of RU-486 and institute an independent review of the approval process the FDA used to declare this drug safe and effective.

Take Action: Contact your representative. Ask him or her to pass Holly's Law! The lives of women and their unborn children can no longer wait. Capitol Switchboard: 202-225-3121. Or, enter your zip code in the box at right to send an e-mail.

For more information:
Individual Safety Reports
Deadly Approval
How to Report a Complication