WASHINGTON -- After months of demonstrating that the Food and Drug Administration can be tougher in regulating drugs and medical devices, Commissioner David A. Kessler announced yesterday his second major thrust since taking office: a program of rapid approval for biotechnology products.
The products, mainly produced through genetic engineering, are considered the next big breakthrough area for the pharmaceutical industry, whose leaders hailed Mr. Kessler's announcement.
Mr. Kessler said he would hire 50 new experts solely to review and approve biotechnology products. He said the drug agency's center that reviews biotechnology products would be reorganized under a new chief, Dr. Kathryn C. Zoon.
A top official of the agency said the announcement was intended to signal industry "that the agency will not be obstructionist."
"We are signaling to the industry."
The official called the step one of the most important since Mr. Kessler took office 16 months ago.
According to a survey by the Pharmaceutical Manufacturers Association, only two biotechnology products were approved last year at the agency and one the year before. But 21 await approval, 131 are being reviewed and several hundred more will be reviewed soon. Most new products are in biotechnology, company officials said.
They include a wide range of products, from human growth hormone to vaccines, quick pregnancy tests to a life-saving treatment for hairy-cell leukemia. In his announcement yesterday at a meeting of the Massachusetts Biotechnology Council, an industry group, Mr. Kessler spoke of the promise of products created by genetic manipulation. "Not since the discovery of penicillin has there existed the potential for a science to have such a profound impact on the human condition," he said. "We must make full use of it.
Richard Godown, head of the Industrial Biotechnology Association, yesterday's action was especially important because Mr. Kessler had sought money from Congress hire more people but did not get it, "so he had to squeeze it out of an already underfunded agency."
The 50 new reviewers will be chiefly medical doctors and holders of doctoral degrees, to add to the approximately 200 now working in the Center for Biologics Evaluation and Research on biotechnology products.