Washington Editor

The FDA's Center for Biologics Evaluation and Research issued a positive annual report saying it has met or exceeded most of the higher performance goals Congress set in the Prescription Drug User Fee Act (PDUFA) III.

PDUFA III gives the agency authority to charge pharmaceutical and biotechnology companies a fee when they submit new drug applications or biologics license applications. When PDUFA was reauthorized in 2002, the industry agreed to higher fees (from $300,000 per application to $400,000) in exchange for quicker drug reviews. Jesse Goodman, director of the Center for Biologics Evaluation and Research (CBER), said that in 2003 the division reached its goals.

Specifically, the agency released figures stating that CBER approved 22 BLAs in 2003, compared to 21 in 2002 and 16 in 2001. The median review time for priority BLAs (six in total) was 12.1 months, up slightly from 12 months in 2002 (five in total).

The median approval times for regular user-fee BLAs was 20 months, down from 28 months in 2002, and the median approval time for non-user-fee BLAs was nine months, compared to 13 in 2002. (See BioWorld Today, Jan. 20, 2004.)

Overall, the FDA said the median review time for BLAs in 2003 was 12.8 months, compared to 12.9 months in 2002 and 13.8 in 2001.

The figures do not include all product classes, since many were transferred to the Center for Drug Evaluation and Research (CDER). Classes currently under the authority of CDER include monoclonal antibodies for in vivo use; cytokines, growth factors, enzymes, immunomodulators and thrombolytics; and proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of those products (except clotting factors). (See BioWorld Today, June 30, 2003.)

In 2004, CBER expects to make progress on a number of initiatives that support the goals of the FDA's plan, including efficient risk management, improving health care through better information, improving patient and consumer safety, protection from terrorism and smarter regulation through a stronger work force, Goodman said.

The agency also intends to implement its critical path initiative, a plan designed to help the industry gain a better understanding of what's expected in the drug application process. That initiative is part of a goal to make the agency more transparent. (See BioWorld Today, April 15, 2004.)

Also, the report notes that 2003 was Goodman's first year on the job. He replaced Kathryn Zoon, who accepted a position with the National Cancer Institute. (See BioWorld Today, Dec. 16, 2002.)