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Executive Summary

Intramural research programs at FDA's Center for Biologics Evaluation and Research must be preserved in order for the agency to be able to review adequately new biotechnology products, Division of Cytokine Biology Kathyrn Zoon, PhD, contended at the Nov. 8-9 meeting of the Edwards Committee's Subcommittee on Drugs and Biologics. "Don't eliminate the research as a component because I think you'd be doing the agency as well as public health a disservice," Zoon told the subcommittee. "We have the flexibility to have staff dedicated to regulatory activities, but I think you can't just say the research is not an important component of our organization for without it we can not perform our duties responsibly." Subcommittee Chairman Lawrence Horowitz had asked Zoon whether it would be possible for CBER to maintain its research programs while managing the " quadrupled workload" that is expected from the biotech products now in development. CBER has "the capacity to shift the ratio between the research and the regulation already at our disposal," Zoon replied. Defending the center's research activities, Zoon said CBER deals with "issues that you have to work out at a level of the [sciences]." She suggested that the only way to deal with these issues in a "meaningful [way] and then translate it to the industry is by having people that actively work in that area." Also speaking on the subject of CBER research, Bruce Merchant, MD/PhD, spokesperson for the Association of Biotechnology Companies and a former CBER staffer, said that "the research activity within CBER is, I believe, extremely important." However, he suggested that the research activity "can be abused." There are incidences "in which personal scientific interests impede an individual's time spent on critical regulatory review," Merchant maintained. He added that research and regulation can be accomplished side by side with "effective management within the agency." Asked by Horowitz whether he thought CBER was capable of handling the the anticipated wave of new biotech applications, Merchant answered: "Absolutely, because if the workload quadruples, I think that it's very appropriate for there to be corresponding increases in staff." Horowitz also asked Merchant for his thoughts on FDA's current organizational structure with separate centers for drugs and biologics. Merchant said he sees "both systems working rather well in a parallel fashion." Immunex Corporation Chairman Stephen Duzan said that "whether [drugs and biologics are] organized into separate arms or a single entity, to me is not the issue: both kinds of expertise need to be resident at the FDA, both sets of capabilities have to be there." Duzan noted that "there will be instances where products are going to necessarily draw on both. Whatever makes sense in the form of an organizational structure is more important that mandating some kind of amalgamation." Acknowledging the "clear differences in statute-based procedure" between the two centers, Center for Drug Evaluation and Research Director Carl Peck, MD, said there are "clear indications that the two centers are moving towards a more common approach." CBER has "rich research, hands-on, state-of-the-art capacity to ask the right questions and make sound judgments based on personal experience," Peck said. CDER's experience with clinical evaluation of efficacy and toxicity provides "our capacity for guiding drug development programs, which is where I think we're moving towards [CBER], being more and more involved in product development." CDER may actually be at a disadvantage by not having a research program like CBER, Peck suggested. "We're probably more cautious than we need to be, he told the subcommittee. "Because our scientists are not engaged at the moment, simultaneously, in research, they may ask more questions, they may be less certain about some answers than an active scientist would be."

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