Court: FDA Should Provide Group More Documents on RU 486 Abortion Drug

National   |   Steven Ertelt   |   Jun 6, 2006   |   9:00AM   |   WASHINGTON, DC

Court: FDA Should Provide Group More Documents on RU 486 Abortion Drug Email this article
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by Steven Ertelt Editor
June 6, 2006

Washington, DC ( — A federal appeals court has ruled that the Food and Drug Administration did not provide an adequate enough explanation to a judicial watchdog group about why it would not hand over more than 6,000 pages of documents about the approval process behind the dangerous RU 486 abortion drug.

The U.S. Court of Appeals for the District of Columbia ruled that a lawsuit Judicial Watch filed against the federal agency should return to the U.S District Court for the District of Columbia.

There, the district court should further review the case and order the FDA to provide more information about the documents it withheld in response to Judicial Watch’s 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.

This allows the group or individual requesting the documents to legally challenge those that are withheld and for a court to determine if they were appropriately withheld.

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," the court ruled. "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."

“We are pleased the court will not allow the FDA to continue to subvert with the open records process,” said JW President Tom Fitton in a statement provided to

“The American people have a right to know why a dangerous and deadly drug was approved by an agency charged with protecting public health," Fitton said. "Judicial Watch will continue to aggressively push for the release of documents related to the approval of RU-486.”

Shortly after the FDA rushed the approval process for the dangerous abortion drug in the waning days of the Clinton administration, Judicial Watch filed a FOIA request seeking all FDA documents related to the approval process.

When the FDA failed to produce documents, Judicial Watch filed a lawsuit.

The FDA provided 9,000 documents but withheld 4,000 more and provided only limited information about another 2,000.

The abortion drug has been responsible for the deaths of seven women in the United States and has injured more than 950 women.

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