Anti-xenotransplant group asks for summary judgment in case against FDA

Last Updated: 2002-01-16 11:41:03 EST (Reuters Health)

NEW YORK - The Campaign for Responsible Transplantation (CRT) said on Wednesday that it has asked a US District Court for a summary judgment ruling in the non-profit organization's lawsuit against the US Food and Drug Administration (FDA), which would force the agency to release documents allegedly detailing the potential risks of xenotransplantation.

According to CRT Director Alix Fano, in March 2000 the organization made repeated requests under the Freedom of Information Act (FOIA) to the FDA for information on clinical trials in which animal cells, tissue and organs are transplanted into humans.

In violation of the FOIA, the agency did not respond to these initial requests, Fano told Reuters Health. CRT subsequently filed a lawsuit against the agency in November 2000 to force the release of the roughly 32,000 documents. (See Reuters Health report, November 27, 2000.)

"This [request for summary judgment] is the culmination of almost two years of haggling with the FDA over trying to get this information," Fano said.

Lawyers representing CRT in the suit said that they expect the court will compel the FDA to disclose a portion of the requested documents, but if not, at the very least require that the agency provide justification for the withholding of the information.

The lawyers added that the dispute is expected to be resolved by early September.

FDA officials were not immediately available for comment.

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