Judicial Watch • Judicial Watch Goes Before Appellate Court to Force Release of FDA RU-486 Records

Judicial Watch Goes Before Appellate Court to Force Release of FDA RU-486 Records

Judicial Watch Goes Before Appellate Court to Force Release of FDA RU-486 Records

APRIL 20, 2006

Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced that oral argument is scheduled for next week in the U.S. Court of Appeals for the District of Columbia Circuit on Judicial Watch’s Freedom of Information Act (FOIA) lawsuit against the FDA over documents concerning RU-486. The argument is scheduled for Tuesday, April 25th at 9:30 AM (Judicial Watch, Inc. v. Food and Drug Administration, et al. (APPEAL 05-5256)). The FDA continues to withhold more than 4,000 documents from the public pertaining to the approval process used for the abortion pill, which has been linked to the deaths of at least six women.

Nearly six years ago, the Clinton administration rushed the abortion pill RU-486 through the FDA’s drug approval process in an effort to appease radical pro-abortion activists. Through use of the FOIA, and later through litigation, Judicial Watch discovered that RU-486 was approved under the "Accelerated Approval of New Drugs for Serious or Life-threatening Illnesses," a measure that was adopted for use in rare cases to encourage the manufacture and importation of drugs designed to treat life-threatening diseases such as cancer or heart disease.

Judicial Watch also uncovered clinical trials and other documents that revealed serious health complications resulting from the use of the drug, including over 840 "Adverse Event Reports" that describe hospitalizations, severe infections, internal bleeding and other complications. The documents uncovered by Judicial Watch spurred calls for the drug’s removal from the market. At least six American women have died after taking RU-486.

The FDA partially complied with a court order by releasing 9,300 documents to Judicial Watch. However, the FDA has failed to adequately describe in its three-volume, 1,500-page Vaughn Index the more than 4,000 documents it withheld from release to the public. The FDA’s RU-486 index, which is supposed to accurately describe in detail which documents are being withheld along with the reasons for the failure to disclose, contains thousands of documents without full descriptions, dates or any basis for the claims of exemption.

"The FDA continues to abuse the open records process by withholding pertinent health information from the public," said Judicial Watch President Tom Fitton. "We’re tired of the FDA’s stonewalling the public’s right to know about the political motivations behind the RU-486 approval process, as well as the inherent dangers of this abortion drug."

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