Washington Editor

Kathryn Zoon said the FDA's move to transfer some regulatory responsibilities from the Center for Biologics Evaluation and Research to the drugs division played a part in her decision to resign, effective in January.

Zoon, who has served as director of the Center for Biologics Evaluation and Research (CBER) since 1992, sent an e-mail to her staff Friday saying she will leave the agency to join the National Cancer Institute as principal deputy of the Center for Cancer Research.

"The most important reason for this decision was an opportunity to return to a more research-oriented job," Zoon said in the e-mail. "As center director, much of my time has been diverted away from science to other tasks. In this new position, I will be working to help transfer promising new treatments from the experimental stage to a larger patient population."

Zoon's resignation comes on the heels of the swearing-in ceremony for Mark McClellan, President Bush's newly appointed FDA director. But more importantly, it follows Lester Crawford's decision to give some of Zoon's responsibilities to CDER, the Center for Drug Evaluation and Research. Crawford, FDA deputy commissioner, headed up the agency before McClellan came along. (See BioWorld Today, Sept. 9, 2002.)

Crawford hoped to speed the review time of biologics by transferring the application process to the drugs center.

While the FDA has previously stated that biologics license applications (BLAs) are more complicated and difficult to comprehend than new drug applications (NDAs), figures provided by the agency show a startling disparity in the speed at which applications are reviewed.

According to the agency, in 2001, CBER reviewed 16 BLAs in a median time of 13.8 months and approved them in a median time of 20.3 months. Comparatively, CDER reviewed 66 NDAs, including 10 priority products that made it through in a median time of six months. The review time for the other 56 products was 12 months, and there was a median time of 14 months for approval. (See BioWorld Today, Jan. 29, 2002.)

Crawford said the transferring plan would free up CBER to focus on blood products, vaccines, gene therapy and tissue transplantation.

"It would be wrong to say I am leaving because of the decision to transfer some regulatory responsibility away from CBER," Zoon said in the e-mail. "It would be just as wrong to say that decision had no influence on my decision to leave FDA."

Before becoming director of CBER in March 1992, Zoon was the director of the Division of Cytokine Biology in CBER. From 1975 to 1980, she worked at the National Institutes of Health on the production and purification of human interferons. She earned her Ph.D. in biochemistry from Johns Hopkins University in Baltimore.