FDA lifting the blind
WASHINGTON - The FDA's proposal to release information from gene therapy and xenotransplantation INDs has elicited a wide range of responses from industry, from predictions that it would have a positive impact to concerns that it threatens the ability of companies to develop and market therapies, unfairly stigmatizes the two technologies, and sets a precedent for lifting the confidentiality that cloaks most data submitted to the agency.
Last week's Federal Register notice proposing the new policy was FDA's final major new policy announcement under the Clinton administration. The agency started to develop the rule 18 months ago, shortly after a patient died in a clinical trial at the University of Pennsylvania's Institute for Human Gene Therapy. In response, NIH took steps to collect and disseminate adverse event reports from gene therapy trials.
At the same time, members of Congress, academic researchers and patient advocates charged that FDA was improperly allowing companies to keep secret important information about the