By John-Henry Westen
WASHINGTON, April 25, 2006 (LifeSiteNews.com) – A hearing this morning at the U.S. Court of Appeals for the District of Columbia Circuit concerned a Freedom of Information Act (FOIA) lawsuit against the FDA over documents concerning RU-486.Â Judicial Watch, the public interest group that investigates and prosecutes government corruption, has demanded that the FDA release 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.
Judicial Watch President Tom Fitton told LifeSiteNews.com that two of the three justices expressed concern about the “sufficiency of the Vaughn index” the FDA presented.Â In other words, the reasons given by the FDA for the documents to be denied public access were too vague.Â
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”.ÂÂThat measure 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 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.”
A ruling from the court is expected within the next few months.