Judge orders FDA to justify withholding documents on xenotransplantation

By Ori Twersky

WASHINGTON (Reuters Health) – A federal judge has ruled that the US Food and Drug Administration (FDA) failed to provide adequate reasons for withholding from the Campaign for Responsible Transplantation (CRT) approximately 27,000 records concerning clinical trials of cross-species transplants, the advocacy group said on Wednesday.

CRT is a coalition of about 90 public-interest groups seeking to ban xenotransplantation. The group believes that the technology – which involves transplanting animal cells, tissues or organs into humans – is dangerous, expensive, unnecessary and inhumane.

The ruling by a US District Court for the District of Columbia comes in response to the nonprofit’s request for a summary judgment in its November 2000 lawsuit against the FDA concerning document allegedly detailing the risks of xenotransplantation. (See Reuters Health Report, January 16, 2002.)

CRT filed a request for the documents in March 2000 under the Freedom of Information Act (FOIA) to obtain data on the side effects seen during clinical trials, including rates of infection and death. The group filed suit the following November after the FDA refused to grant the FOIA request.

CRT said in a statement on Wednesday that Judge Ricardo M. Urbina of the US District Court of Columbia has given the FDA until November 10, 2002, to provide further justification for withholding the record at issue and to supply additional documents and affidavits in its defense. The group said the judge also order both parties to resume settlement talks.

“It’s a major victory for us because we have been going through two years of litigation with the FDA telling us that we have no case,” CRT director Alix Fano told Reuters Health. “This ruling validates our case.”

“We know that since the early 1990s there have been at least 16 deaths,” Fano added. “These deaths were attributed to underlying conditions, but we want to see what role xenotransplantation might have played in causing these deaths.”

Federal law requires agencies such as the FDA to release certain document to the public upon request. But the law also provides certain statutory exemptions.

According to CRT, the FDA claimed that the records were protected as either trade secrets or confidential commercial information and because they would reveal internal agency discussions. The Judge ruled on Tuesday that the agency failed to prove that it could withhold the records, because it did not describe in sufficient detail whether the documents qualified as trade secrets or commercial information. The judge also concluded that the agency’s contentions about disclosure of internal FDA discussions were “vague” and “conclusory,” Fano said.

In its lawsuit, CRT maintained that the records it request should not be exempted from disclosure because the trial sponsors already released details about their experiments to the media and the public through press releases, the Internet and presentations at FDA-sponsored public meetings.