ELECTRONIC FILING SYSTEM MEANT TO ACCELERATE, IMPROVE BIOLOGICS REVIEWS

CBER is increasing the use of electronic applications for new biologics in order to ensure more efficient, effective and consistent reviews, an agency official said.

The FDA is not able to address new biologics license applications (BLAs) as efficiently as possible under the current paper-based system, Robert Yetter, CBER's associate director for review management, said. Applications take longer to process, and the agency lacks a repository of easily accessible information to improve the review process going forward. To address the problem, the agency is seeking more electronic submissions and is developing systems for handling them.

Greater use of electronic applications will both improve the FDA's handling of individual reviews and help it develop an electronic archive of BLAs to foster greater consistency in the future, Yetter told attendees at an Oct. 17 Regulatory Affairs Professionals Society conference.

The agency will be able to analyze the data to make sure that the FDA's science and regulatory interpretations are consistent and supportable. There is a "benefit for us, the industry and the public health" as the approach will "allow [the agency] to do a better regulatory job."

An electronic system has the additional benefit of being less resource intensive, a necessity given that many of the CBER offices are understaffed, James Kenimer, president and CEO of The Biologics Consulting Group, said. Staffing problems stem from insufficient funding to hire and keep personnel and declining morale because of the perception that the agency is becoming more of a political entity, he said.