Transplant Societies Protest FDA Policy In American Journal Of Transplantation

Main Category: Transplants / Organ Donations
Article Date: 21 Mar 2008 - 0:00 PDT

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In an Open Letter to the Federal Drug Administrations (FDA), which appears in the April issue of the American Journal of Transplantation (AJT), the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS) explain how FDA policy is thwarting the field of transplant medicine in the United States. Flavio Vincenti, MD, president of the AST and one of the letter's authors, described the letter as an appeal to the FDA to reconsider its policy.

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

In summary, FDA policy mandates the use of immunosuppressive drugs in organ transplantation clinical trials (in the control arms) that are no longer the preferred regimen of drugs of transplant physicians. The letter can be reviewed by going to http://www.a-s-t.org.

About AST

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

American Society of Transplantation
http://www.a-s-t.org