FDA PROPOSES A NEW PUBLIC DISCLOSURE RULE FOR GENE THERAPY AND XENOTRANSPLANTATION CLINICAL TRIALS

The Food and Drug Administration (FDA) today issued a proposed rule that would make publicly available information on all new or ongoing clinical trials involving either gene therapy or xenotransplantation. Under this proposed rule, published today in the Federal Register, FDA would provide public access to most of the study design and safety information about these types of studies. FDA would not release confidential business information or personal information related to study participants.

“Today’s action is an important step in ensuring greater public confidence in these revolutionary therapeutic technologies,” said FDA Commissioner, Jane E. Henney, M.D. “ Both of these technologies hold great promise, but they may also pose a remote, but unique risk to the individuals who have volunteered to participate in these types of studies. Our proposal will ensure that the public is fully informed as we investigate these new public health opportunities and challenges.”

Human gene therapy is defined as the administration of genetic material to modify or manipulate the expression of a gene product or to alter the biological properties of living cells for therapeutic use. Cells may be modified outside the body (ex vivo) for subsequent administration to the subject or altered in the body (in vivo) by gene therapy products given directly to the subject.

Xenotransplantation refers to any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (1) live cells, tissues, or organs from a nonhuman animal source; or (2) human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.

The proposal will also ensure that FDA’s policies for public access to this information are compatible with those of other government agencies that oversee these types of research. Much of the information that would be disclosed about gene therapy trials under this proposal is already publicly discussed in open meetings of the Recombinant DNA Advisory Committee of the National Institutes of Health. Similarly, information about xenotransplantation trials will also be publicly available through the Secretary’s Advisory Committee on Xenotransplantation, which is being assembled by the Department of Health and Human Services.

Under the rulemaking process there will a 90 day public comment period on this proposal. Written comments may be submitted to:

Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane
Room 10-61
HFA-305
Rockville, Maryland 20852

Comments can also be e-mailed to FDADOCKETS@OC.FDA.GOV. These comments will be considered in the development of any final rule.

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