BIO Raises Concerns About FDA’s Proposed Rule On Disclosure Of Gene Therapy Trial Data

WASHINGTON, D.C. (January 17, 2001) -- Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO) issued the following statement on the U.S. Food and Drug Administration’s (FDA) proposed rule governing disclosure of data from gene therapy and xenotransplantation clinical trials.

“BIO has several concerns with the FDA’s proposed rule for public disclosure of data involving clinical trials of gene therapy and xenotransplantation medicines,” Feldbaum said.

“First, the FDA is proposing public disclosure of information that may compromise patients’ rights to medical confidentiality and companies’ rights to confidentiality of trade secrets involving their innovative medicines. Although the FDA has said such data would be redacted from publicly disclosed materials, there are no assurances some sensitive information would not be revealed.

“Second,” Feldbaum said, “disclosing data on all adverse events in clinical trials without first investigating the causes could unnecessarily frighten patients and the public. The vast majority of adverse events in clinical trials are related to the patients’ underlying diseases, not the experimental medicines. Under current regulations, when the cause of an adverse event is linked to the drug being tested, the FDA immediately shuts down the clinical trial.

“Third, the proposed disclosure rule is a dramatic deviation from 30 years of FDA regulations and practice. This is a troubling precedent. The legal arguments made by the FDA in its proposal are not specific to gene therapy and xenotransplantation.

“The FDA regulates all aspects of clinical trials and in the case ofgene therapy and xenotransplantation, some clinical trial protocols also are reviewed in public forums before they begin by the National Institutes of Health’s Recombinant DNA Advisory Committee.

“Protecting patients in clinical trials is paramount,” Feldbaum added. “Making sure trial protocols are safe and closely monitoring their progress is essential; so is making sure patients understand the risks involved in clinical trials. Existing rules provide these protections.

“Requiring disclosure of information that has no bearing on patients or the public could hinder the progress of innovative drug development.”

BIO represents more than 950 biotech companies, academic institutions and biotech centers in all 50 U.S. states and 26 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental products.