DeLauro Holds Hearing on FDA Budget for The Center on Biologics Evaluation and Research

Statement

The hearing will come to order. Today, we welcome to the subcommittee, Dr. Jesse Goodman, who is Director of the FDA's Center for Biologics Evaluation and Research (CBER), which oversees vaccines, blood products, tissues, and related devices, as well as therapeutics including cellular, tissue engineering and gene therapies. Thank you for coming today Dr. Goodman.

Today's hearing on the Center for Biologics Evaluation and Research is the second in a series of oversight hearings that take a closer look at each of the Centers at the FDA. We began this series with a hearing on February 27 examining the Center for Drug Evaluation and Research (CDER). While the Center for Drug Evaluation and Research receives more attention because of its responsibility overseeing the safety of prescription drugs, Center for Biologics Evaluation and Research's regulation of biological and related products is equally important. I believe this is the first time this subcommittee has held a hearing focused exclusively on CBER.

Unfortunately, the importance of its mission is not reflected in the FY 2009 budget request for Center for Biologics Evaluation and Research. The non-user fee part of CBER's budget request for FY 2009 is $158 million, an increase of just under $3 million, or a mere 1.9 percent over FY 2008. While the budget request document contains a lengthy description that tries to make this tiny increase sound like it will accomplish a lot, I fear that will not be adequate.

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If we are to return the FDA to the gold standard for which it was once known, the agency will need additional resources. The subcommittee is trying to do our part, but we also need the Administration to demonstrate their commitment to improving FDA. Unfortunately, the Administration's budget request for the agency, and for CBER, does not reflect any type of commitment toward making the necessary improvements.

Providing additional resources could help leverage some of the good work being done at CBER. For instance, in your testimony, Dr. Goodman, you talk about CBER's interdisciplinary review teams and how they work together to design and analyze results of post-approval monitoring. You also note that CBER has established product safety teams for tissue, blood, and vaccines. This sounds like a serious effort for which I would like to know more about.

The good thing about holding an oversight hearing on CBER is that it allows us the opportunity to examine a number of important issues that we normally would not have the chance to discuss in depth. These include tissue safety, and recalls of blood and blood products. In fact, on these issues, some of the responses to questions for the record last year by the FDA were unsatisfactory and require follow-up discussion. This hearing provides that opportunity for the subcommittee.

Thank you again for being here, Dr. Goodman. I look forward to discussing these issues with you and I appreciate your willingness to rearrange your schedule to accommodate the subcommittee.

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