6/06/2006

United States Court of Appeals: FDA Failed to Provide Adequate Explanation for Withholding Abortion Pill Documents
Case Remanded Back to U.S. District Court for Further Review

WASHINGTON, June 6 /Christian Newswire/ -- Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced today that the U.S. Court of Appeals for the District of Columbia Circuit ruled that the Food and Drug Administration (FDA) failed to provide adequate explanations for withholding more than 6,000 documents from Judicial Watch related to the approval of the abortion pill RU- 486. The appellate court remanded the case back 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 in response to a Judicial Watch Freedom of Information Act (FOIA) request.

When a federal agency refuses to release documents responsive to a FOIA request, it is required by law to produce a Vaughn index, which describes in detail the documents withheld along with the reasons for withholding them. The purpose is to allow the requester to challenge individual documents, and for the court to determine if the exemptions invoked by the government hold merit. The appellate court agreed with Judicial Watch that many of the FDA’s Vaughn index descriptions for the RU-486 documents were inadequate.

“...The FDA labeled many index entries with scientific codes, lab jargon, or other identifications specific to the agency...By using this shorthand, the FDA missed sight of the Vaughn index’s purpose – to enable the court and the opposing party to understand the withheld information in order to address the merits of the claimed exemptions,” the court ruled. “We accordingly remand the case for further explanation of these technical descriptions...”

Because federal agencies are allowed to withhold documents produced prior to the adoption of an agency policy, or documents that reflect the “consultative process,” the court also ruled the FDA must provide “dates for documents that lack them or explanations where dates cannot be found.”

Shortly after the FDA rushed the abortion pill RU-486 to market in the United States in the closing days of the Clinton administration, Judicial Watch filed a FOIA request seeking all FDA documents related to the RU- 486 approval process. When the FDA failed to produce documents, Judicial Watch filed a lawsuit. The U.S. District Court for the District of Columbia ordered the FDA to produce all responsive documents by October 15, 2001. The FDA disclosed 9,000 documents, but withheld over 4,000 in their entirety and parts of almost 2,000 more. (Documents previously uncovered by Judicial Watch led to calls on the Bush administration to take RU-486 to be taken off the market.)

“We are pleased the court will not allow the FDA to continue to subvert with the open records process,” said JW President Tom Fitton. “The American people have a right to know why a dangerous and deadly drug was approved by an agency charged with protecting public health. Judicial Watch will continue to aggressively push for the release of documents related to the approval of RU-486.”

To read a copy of the court’s opinion, visit www.judicialwatch.org