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FDA proposed rule requires public access to information on gene therapy, xenotransplantation clinical trials.

In a move designed to assure that human subjects involved in xenotransplantation or gene therapy trials are being properly monitored for safety, the US Food and Drug Administration (FDA) has issued a proposed rule that would require public access to information on all new or ongoing studies.

Under the proposed rule published in the January 17 Federal Register, the FDA would provide information to the public on most of the study design and safety information about gene and xenotransplantation studies. The FDA said it will not release confidential business information or personal information related to study participants, however.

FDA Commissioner Jane Henney, MD, called the agency's action an "important step in ensuring greater public confidence" in the often controversial technologies. Henney pointed out however that while both technologies hold "great promise," they also "may pose a remote, but unique risk to the individuals who have volunteered to participate" in the studies.

"Our proposal will ensure that the public is fully informed as we investigate these new public health opportunities and challenges," she added. (Editor's note: At the request of President Bush, Henney resigned as FDA Commissioner on January 2. Her successor has not been named.)

The US biotechnology industry immediately let it be known that it does not agree with the FDA's decision to make the research information public.

Michael Werner, bioethics counsel of the Biotechnology Industry Association (BIO), expressed concern that the broad wording of the FDA's proposed rule may lead to the agency releasing more data about all clinical trials not just about gene therapy and xenotransplantation.

"The rationale they use and the legal arguments that they use are not specific to those technologies," Werner said. "Therefore, it could be that they are thinking, in general, that data from clinical trials could be released inappropriately, and that's of great concern."

Werner added if the proposed rule is "just about gene therapy and xenotransplantation they're being unfairly targeted and the regulations are inappropriate."

Carl Feldbaum, BIO chairman, issued a statement on the FDA's rule charging that 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."

BIO also objected strongly to the FDA's intention of releasing information on adverse events involving patients before the causes are determined. Charging that the release of such data could unnecessarily frighten the public, Feldbaum argued that "vast majority of adverse events in clinical trials are related to the patients' underlying diseases."

FDA said the proposed rule will ensure that the agency's policies for public access to the information are compatible with those of other government agencies that oversee similar types of research.

Most of the information that would be discovered about gene therapy trials under the proposal is already publicly discussed in open meetings of the Recombinant DNA Advisory Committee of the National Institutes of Health, the FDA said. Similarly, information about xenotransplantation trials will be publicly available through the Secretary's Advisory Committee on Xenotransplantation (SACX), which will hold its first meeting on February 20-21 in Rockville, MD.

The proposed rule is posted on the Internet - Under the rulemaking process, there is a 90-day public comment period on the proposal. Written comments should be submitted to: Dockets Management Branch, FDA, 5630 Fishers Lane, Room 10-61 HFA-305, Rockville, MD 20852. Comments may also be e-mailed to FDADOCKETS@OC.FDA.GOV
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Title Annotation:Government Activity
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Feb 16, 2001
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