Group Threatens To Sue HHS Over Xenotransplant Policy

FDA Week, Aug. 13, 1999, p.11

An international health advocacy group called the Campaign for Responsible Transplantation (CRT) is threatening to sue HHS if the agency does not respond to a legal petition opposing xenotransplantation the group filed last December, according to a CRT source. The petition asks the agency to ban xenotransplantation generally, and criticizes HHS for allegedly not performing appropriate impact studies. According to the CRT source, HHS has until Aug. 16 to reply, and after that the group will seriously consider filing a suit.

The group has sent HHS Secretary Donna Shalala two letters since December, dated May 26 and July 30, requesting a response and threatening to take the agency to court on tne grounds of "constructive denial" and "failure to act" under the Administrative Procedures Act.

While HHS has yet to formally reply to CRT's petition, a source close to the agency said that a response is currently being prepared that will reflect input from FDA, the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) - all of which received copies of the petition and the subsequent CRT letters.

CRT's petition argues that when HHS issued its draft xenotransplantation guidelines the agency violated the Public Health Service Act on five counts: 1. HHS did not adequately consider the safety of xenograft recipients; 2. HHS failed to adequately consider the effectiveness and efficacy of xenotransplantation; 3. HHS did not adequately consider the social, ethical, and legal implications of xenotransplantation; 4. HHS did not adequately consider the cost of xenotransplantation; 5. HHS failed to comply with NEPA [National Environmental Policy Act]. Under NEPA an environmental impact study is required.

A source close to HHS suggested that some of the criticisms in the petition may be unfounded or even inapplicable, but did not specify which ones. Other sources point out that it is precisely these sorts of issues that the xenotransplant advisory committee currently being established by HHS is intended to address (see FDA Week, July 30, p1). The committee, which would operate out of NIH's office of the Recombinant DNA Advisory Committee (RAC), will consist of representatives from FDA, CDC, and NIH.

It is unclear if HHS can do anything to satisfy CRT's concerns. The source from CRT says that it is impossible to responsibly develop xenotransplant technology.

Reprinted with permission from FDA Week. (800) 424-9068