US FDA gene therapy data plan: BIO fears

The US Biotechnology Industry Association has announced that it has anumber of serious concerns relating to the Food and Drug Administration's proposed new rule governing disclosure of information from gene therapy and xenotransplantation clinical trials (see also page 26).

The industry's first concern, according to BIO president Carl Feldbaum, relates to the FDA's proposal for the public disclosure of information which may compromise both patients' rights to medical confidentiality and companies' rights to confidentiality of trade secrets involving their innovative medicines. Although the FDA has stated that such data would be redacted from publicly-disclosed materials, there are no assurances that some sensitive information would not be revealed, said Mr Feldbaum.

Disclosure "could frighten patients and public unnecessarily"