CBER/CDER Consolidation Receives McClellan’s Blessing; Tensions Continue

Incoming Commissioner Mark McClellan, MD/PhD, is indicating strong support of the shift of biological product reviews from the Center for Biologics Evaluation & Research to the Center for Drug Evaluation & Research.

"The goal of this initiative is to bring under one roof the reviews of products in clinical development and clinical data analysis and their use in medical practice," McClellan told analysts at Schwab's Washington Research Group Annual Symposium in Washington, D.C., Nov. 7.

"This shift will enable the biologics center to focus its expertise on some of what I think are the most challenging regulatory and innovation issues in the years ahead," he declared, noting the importance of CBER's review of vaccines and other countermeasures against bioterrorism.

"Some of the most important challenges facing FDA are those facing the center for biologicals, and we want to make sure that those challenges are addressed effectively."

McClellan noted that CBER will continue to be responsible for "products like vaccines and countermeasures for bioterrorism, which are absolutely critical for homeland defense, and which need to be developed rapidly," as well as blood products, gene therapy and human tissue products.

"But there are some concerns about the safety and adequacy of our good manufacturing, of manufacturing product processes in this area" of human tissue products, he added.

CDER Deputy Director Steven Galson, MD, acknowledged the tensions surrounding the product review shift during a Nov. 5 "CDER Live" discussion.

"This has been a very difficult step for many people in the agency, and we value very, very highly the scientific expertise and the individuals and all they've contributed in CBER, and we really have very high hope and expectations that we'll be able to retain that expertise in CDER," he said.

Galson emphasized that shifting the review of therapeutic biologics from CBER to CDER is not expected to extend review times.

"As we've talked about since the agency began talking about the consolidation, the products that do move into the Center for Drugs will move with the appropriate staff and with the appropriate support and resources, and so it should not have any impact on review times or review quality, of course."

CDER Director Janet Woodcock, MD, is understood to have met on Nov. 7 with many of the CBER staff members expected to be transferred under the consolidation.

Some CBER scientists have indicated their intent to leave the agency because of the transfer, and CBER Director Kathryn Zoon, PhD, has publicly discussed her concerns with retention (^{1 3} (Also see "CBER/CDER Reorganization: Product Transfer Set, Resources Under Review" - Pink Sheet, 4 Nov, 2002.), p. 24). Concerns also have been raised about the ability of CBER's new gene therapy office to function under the new system (² (Also see "CBER Gene Therapy Office May Be Isolated In FDA Reorganization Plan" - Pink Sheet, 4 Nov, 2002.), p. 26).

Several biotech firms, including MedImmune, Idec and Centocor, have written to McClellan and FDA Deputy Commissioner Crawford, urging them to reconsider the consolidation. Some of the letters raise concerns about the process by which the consolidation was decided, and the continuation of intramural research at FDA.

CBER staff and other scientists involved in agency matters are also questioning the reasons behind the move. Some believe that the decision was influenced by the ImClone issue, while others think that slower review times at CBER encouraged the transfer.

FDA Science Board members also expressed concern over the lack of public discussion on the plan prior to its swift implementation, expected to be completed by year-end (^{1 3} (Also see "CBER/CDER Reorganization: Product Transfer Set, Resources Under Review" - Pink Sheet, 4 Nov, 2002.), p. 24).

Noting that the Science Board has reviewed "issues around various centers" over the last three years, board member and Amgen VP-Clinical Safety Assessment Harold Davis, PhD, said he "can't understand...how those issues are any more scientific-oriented for this board than the potential issue around what's going to happen if we should merge CBER into CDER."

"Please understand, I'm not speaking for it or against it at all, it's just the fact that if we're going to do, if the agency's going to do that, I would say that."