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FDA proposes IND data disclosure

January 17, 2001 8:00 AM UTC

The FDA on Wednesday released a proposed rule on the public disclosure of data about gene therapy and xenotransplantation research that would alter the agency's policy of releasing virtually no information about INDs. According to FDA, the two technologies pose unique risks, particularly potential transmission of infectious agents from recipients to the public and inadvertent modification of the germline that can only be addressed through public discussion. The proposed rule would mandate public disclosure of data from gene therapy and xenotransplantation INDs, including data provided by sponsors on product and patient safety, such as results from preclinical and clinical studies; clinical indications to be studied; protocols for planned studies; and identification of the biological product(s) and descriptions of the method of production.

Under the proposal, safety reports would be released to the public when they are submitted to FDA. Changes in regulatory status, such as the imposition and lifting of clinical holds, also would be made public. Trade secrets, confidential commercial information and information that could identify individual patients would be not be disclosed publicly. FDA asserted that most of the information it plans to release is already in the public domain as a result of disclosures by NIH and data that companies provide voluntarily or in response to SEC regulations. ...