From: Jonathan Harpaz [joneve@netvision.net.il]
Sent: Saturday, March 10, 2001 6:25 AM
To: fdadockets@oc.fda.gov
Cc: Jonathan

Docket No. 00N-0989
Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane
Room 10-61 HFA-305
Rockville, MD 20852

 
A proposed rule from the Food and Drug Administration (FDA) would provide public access to most of the study design and safety information on all new or ongoing clinical trials involving either gene therapy or xenotransplantation. The FDA would not release confidential business information or personal information related to study participants.



    a.. This proposal only brings gene therapy and xenotransplantation in compliance with the same types of information already released to the public by other government agencies. 
    b.. Because of the grave public health risks, disclosure should include additional information such as physicians, medical centers, and so on. All information should be made public except trade secrets and patient identification. 
    c.. The FDA must assume the sole responsibility for summarizing and distributing information submitted by the research sponsor, rather than leave it to the sponsor’s discretion. 
    d.. Because of the pubic health risks, ethical issues, cost uncertainty, and the inability to adequately assess other alternatives, all xenotransplantation clinical trials should stop. 
Yours sincerely

J. Harpaz