The FDA intends to speed the review time of biologics by transferring the application process from the biologics center to the drug center.
That doesn't mean the agency intends to eliminate the Center for Biologics Evaluation and Research (CBER), currently responsible for handling all biologics license applications (BLAs). Instead, the intention is to free up CBER to focus on blood products, vaccines, gene therapy and tissue transplantation.
"FDA's drug and biological product reviews have long been the gold standard for the world," Lester Crawford, deputy commissioner of the FDA, said in a prepared statement. "By carefully combining part of our present biologics review operation responsibilities with our drug review operation, FDA will be optimally positioned to uphold that gold standard by continuing to review novel pharmaceutical products promptly and rigorously in an accountable, consistent manner."
And while the agency hasn't released too many details on the pending changes, so far the reception within the industry appears rather positive.
"The companies are registering a positive reaction because of the perceived inconsistencies in the process between CDER [Center for Drug Evaluation and Research] and CBER," Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization, told BioWorld Today. "This came out in our deliberations regarding PDUFA III and we think this development is important and in part stems from those negotiations."
PDUFA, or the Prescription Drug User Fee Act, was first approved by Congress in 1992, and reauthorized in 1997 and again this year. The law gives the FDA the authority to charge pharmaceutical or biotechnology companies a "user fee" to review drug and biologics applications.
When industry and FDA representatives began discussing reauthorization last year, startling figures highlighting the disparity between CDER and CBER review times became an issue.
According to FDA documents, 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 new drug applications (NDAs), including 10 priority products that made it through in a median time of six months. The median review time for the others was 12 months, and there was a median of 14 months for approval. (See BioWorld Today, Jan. 29, 2002.)
BLAs are considerably more complex than NDAs, according to the FDA.
Nevertheless, the agency came under fire again this summer when the House Energy and Commerce Committee questioned the drug approval process following the ImClone Systems Inc. debacle surrounding the cancer drug Erbitux. (See BioWorld Today, July 1, 2002.)
The committee noted protocol violations in the Erbitux clinical trials and suggested to the agency that CBER's fast-track process needed improvement.
Crawford has established a working group to develop by January an implementation action plan and timeline for the consolidation. Murray Lumpkin, senior associate commissioner, will chair that working group.
Susan Cruzan, a spokeswoman for the FDA, deferred all questions surrounding the working group and possible changes at CBER to a brief press release. She would not comment on how the consolidation would impact employees.
The press release stated that the FDA's current policy on generic biologics would not be affected by the consolidation. (Biologics are not included under the Hatch-Waxman Act that created the generics industry.)