CBER-CDER Transition: FDA Creating Template For Product Review Transfer

FDA is creating a template to help it decide what products should be transferred from the Center for Biologics Evaluation & Research to the Center for Drug Evaluation & Research under its proposed reorganization.

Acting Commissioner Lester Crawford told a Women in Government Relations luncheon Oct. 11 that FDA has developed recommendations on what kinds of products should be regulated by CBER based on products already on the market.

FDA decided to "look at all the products of compounds that are being reviewed, and then make a decision on a product by product category," Crawford said.

Crawford says he possesses a listing of "all the products that [CBER] regulates and all the categories that they regulate. And I have the recommendation for sort of the final cut on the names of the things that come there."

"The way we're doing that is we're taking those already on the market, and deciding where they go, and then you'll have the template for deciding what actually comes and what stays behind."

Crawford said FDA will have the transfer of therapeutic biologics from CBER to CDER "effectuated by the end of the year, but maybe not much before then."

Agency officials were evaluating different consolidation plans at least six months before Crawford rejoined FDA in February, the deputy commissioner noted.

"When I got there, there had been an ongoing process for six months....I was given some options," he said.

"One of the options was...merging the center for drugs with the center for biologics, and I said, 'no, we tried that before, so we're not going to do that,'" Crawford said. FDA attempted to consolidate the centers in 1982.

Crawford also noted that former Acting Commissioner Michael Friedman was interested in the transfer of biological therapeutics review in the late 1990s.

FDA's goal is "getting the maximum efficiency and putting together a truly functional, critical mass of experts to evaluate these products. And that occasioned the transfer [of therapeutic biologics] to the center for drugs."

Crawford praised the CBER staff, saying they "have done a good job on the therapeutic biologics, but we either have to beef up the critical mass or they lose people, or we need to transfer it. And transferring, I thought, was a much more useful thing to do than re-merging the centers, so I elected not to do that."

FDA announced its plans to move review of biologic therapeutics from CBER to CDER on Sept. 6 (¹ (Also see "CBER/CDER Consolidation Working Group Set To Meet Week Of Sept. 16" - Pink Sheet, 9 Sep, 2002.), p. 3). The decision followed meetings between House Energy & Commerce Committee staff and CDER Director Janet Woodcock, MD, and CBER Director Kathryn Zoon, PhD.

CBER staff reacted emotionally to the proposed switch at a CBER centennial forum in September (² (Also see "FDA Needs Five Centers, Crawford Says; CBER Centennial Is Emotional Affair" - Pink Sheet, 30 Sep, 2002.), p. 8). One former CBER staffer wrote HHS Secretary Tommy Thompson, urging him to reconsider the switch, which she described as coming independent of consultation with CBER or the biotech industry (³ (Also see "CBER/CDER Reorganization Will Lengthen Reviews, Ex-FDAer Warns HHS" - Pink Sheet, 30 Sep, 2002.), p. 9).

FDA's working group on the CBER/CDER reorganization, chaired by Senior Associate Commissioner Murray Lumpkin, MD, met Oct. 17 and is expected to develop by January an implementation action plan and timeline for the consolidation, which will address logistical issues.

Some CBER reviewers and staff are expected to join the combined CDER team to provide the necessary scientific expertise for biologics reviews.

Specific staff announcements have not been publicized, but it is expected that CBER will lose about 70% of its staff to CDER, and a good portion of the user fees it once received.

The consolidation comes after years of lobbying by the biotechnology industry to bring biologics reviews more in line with drug reviews, particularly in the manufacturing area.