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Wednesday, Sept. 27, 2000
Contact: HRSA Press Office
(301) 443-3376


HHS Secretary Donna E. Shalala today announced creation of an Advisory Committee on Organ Transplantation to strengthen scientific, medical and public involvement in the department's oversight of transplantation policy. In particular, the new committee will provide independent review and advice to HHS concerning revised organ allocation policies being developed by the nation's transplantation network.

The new committee, to be formed this fall, was recommended by the Institute of Medicine (IOM) in a report mandated by Congress in 1998.

"In its report to Congress, the Institute of Medicine endorsed the role of HHS in ensuring the fairness and effectiveness of the nation's organ transplantation system," Secretary Shalala said. "At the same time, the IOM recommended creation of a new entity to provide the department with top-notch, science-based counsel on transplantation policy. This new advisory committee will fill that need."

National transplantation policies are developed by the Organ Procurement and Transplantation Network (OPTN) for approval by HHS. Under regulations that took effect earlier this year, the OPTN policies must be designed to meet performance standards to ensure that the system operates in the best interest of patients. The performance standards are included in the HHS regulation and are also consistent with IOM recommendations. In particular, the IOM called for sharing livers for transplantation across broader population areas than at present. The IOM concluded that broader sharing will help ensure that livers are provided to patients with greatest medical need, as determined by transplant physicians.

"The IOM data support our finding that more lives can be saved through broader sharing of organs, with particular focus on livers," Shalala said. "Under the final regulation, the OPTN has been developing proposals for improving liver allocation policies. Our new advisory committee needs to be in place to provide its independent assessment of these proposals."

The IOM report focused on liver transplantation policies because human livers are in such short supply, and because liver allocation policy has been the subject of debate for a number of years. In its regulation, which took effect March 16, HHS made it clear that organ transplantation policies will continue, as previously, to be developed by the transplant community through the OPTN. HHS review and approval is needed to make these policies binding on OPTN members.

This summer, the OPTN has developed proposals for better characterizing the medical condition of patients waiting for a liver transplant. These proposals are currently being made available by the OPTN for public comment. The new advisory committee is to be in place in time to review OPTN proposals when they are submitted to HHS.

In addition to its review of OPTN-developed policies, the advisory committee will examine transplantation data needs, as well as other transplantation issues, including scientific, public health, ethical, coverage and financing issues. The committee will include up to 20 members. Nominations for prospective members must be made within 30 days of publication of the Federal Register notice announcing the committee.

Earlier this month, HHS reported an increase in organ donation for the first half of 2000, and HHS this month also released a new guide to help in the training of hospital staff and others who talk with families of potential organ donors and request organ donation.

"All these steps represent progress toward an organ transplantation system that will serve patients better," Shalala said. "They are signs that we are on a path toward new progress in organ donation and transplantation."


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