Transplant Societies Protest FDA Policy in American Journal of Transplantation

Thursday, March 20, 2008 General News J E 4
MOUNT LAUREL, N.J., March 19 In an Open Letterto the Federal Drug Administrations (FDA), which appears in the April issue ofthe American Journal of Transplantation (AJT), the American Society ofTransplantation (AST) and the American Society of Transplant Surgeons (ASTS)explain how FDA policy is thwarting the field of transplant medicine in theUnited States. Flavio Vincenti, MD, president of the AST and one of theletter's authors, described the letter as an appeal to the FDA to reconsiderits policy.

In summary, FDA policy mandates the use of immunosuppressive drugs inorgan transplantation clinical trials (in the control arms) that are no longerthe preferred regimen of drugs of transplant physicians. The letter can bereviewed by going to .

About AST

The American Society of Transplantation (AST) was founded in 1982 and isan organization of more than 2,700 transplant professionals dedicated toimproving patient care through the promotion of research, education, advocacyand organ donation. AST provides a forum for the exchange of knowledge,scientific information and expertise in the field of transplantation.

If you are interested in speaking with the letter's primary author, Dr.Vincenti, or would like to receive a copy of the letter, please contact BethDrost at 215.884.6499.Vincenti maintains that FDA policy has: -- discouraged many transplant centers from participating in clinical trials of new transplant drugs -- driven American patients away from enrolling in clinical trials -- caused drug companies to seek patients outside the U.S. for clinical trials -- weakened clinical trial results of innovative transplant drugs

SOURCE American Society of Transplantation


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