The Food and Drug Administration has proposed a rule to make information involving xenotransplantation and gene therapy clinical trials available to the public.
On January 17, the FDA published a proposed rule in the Federal Register that would make information publicly available on all new or ongoing clinical trials involving xenotransplantation or gene therapy. Under the rule, the FDA said it would provide public access to most of the study design and safety information about these types of studies but would withhold confidential information related to businesses or study participants.
"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," said FDA Commissioner Jane E. Henney, MD.
The FDA added that information about xenotransplantation trials also will be publicly available through an advisory committee on xenotransplantation being assembled by the Department of Health and Human Services.
The Biotechnology Industry Organization, which represents biotechnology companies and academic institutions, released a statement questioning whether the disclosure of information may compromise both company and patient confidentiality. Another concern, said organization president Carl B. Feldbaum, is that "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."
A 90-day public comment period is underway.
For Your Information:
The FDA's statement is at www.fda.gov/bbs/topics/NEWS/2001/NEW00748.html.
Comments can be e-mailed to FDADOCKETS@OC.FDA.GOV or sent to Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 10-61, HFA-305, Rockville, MD 20852.
The Biotechnology Industry Organization posts its statement at www.bio.org/news/article.html?XP_PUB=press_release&XP_TABLE=articles.db&XP_RECORD=2001_0117_02.
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