WASHINGTON - The FDA took less than 12 months in 1994 toapprove seven biologic therapeutic agents - including two noveltherapeutic agents - compared with nearly two years to review andapprove 10 applications in 1993.

Approved was Centocor Inc.'s ReoPro, an anti-blood clotting agent(marketed by Eli Lilly and Co.) and Enzon Inc.'s Oncaspar, atreatment for acute lymphoblastic leukemia (marketed by Rhone-Poulenc Rorer, Inc).

FDA's Center for Biologics Evaluation and Research (CBER)Deputy Director Mike Beatrice said in an interview with BioWorldToday that the reduced approval times are evidence that that theagency is attempting to trim the time required to review productapplications.

To further demonstrate CBER's willingness to make the regulatoryprocess easier to navigate, Beatrice said the center is working on fourmajor initiatives to provide manufacturers with regulatory relief.They will be on the street within 12 months, he said.

CBER is attempting to make the regulations as flexible as possiblewithin the limits of the law. "Usually changing regulations is a longprocess. However, creative minds can do a lot by interpretingexisting requirements and `flexing' the requirements so that bothCBER and the industry can do more."

Beatrice pointed to the April 7 publication in the Federal Register ofan FDA statement specifying what category of compliance wasneeded when a manufacturer wanted to make what is called an`establishment' change. "That notice stated three levels of regulatorycompliance. A change could be reported voluntarily with no furtheraction by FDA. Or the change could be implemented within 30 daysif the manufacturer notified FDA and supplied supporting data. If themanufacturer did not hear from FDA, it could go ahead andimplement the change. And finally, the most extensive changerequired the manufacturer to obtain a complete approval from theagency."

Several biotech manufacturers have dismissed the April 7 notice asnot enough. "I would buy that. It's not enough," said Beatrice."CBER has several more regulatory changes planned."

Beatrice said CBER was re-writing the establishment regulations tomake them even more flexible. "At the very least we will create threecategories of manufacturing changes that have to be reported, muchlike what CDER [Center for Drug Evaluation and Research] does,"he said.

"The goal is to make the regulation more outcome-oriented rather than focused on the manufacturing process. Theproblem with the regulations now is that they require changes in themanufacturing methods to be reported and approved by the center.We would like to change that. We intend to stipulate that only thosemanufacturing changes that affect the final product must be approvedby CBER," Beatrice said.

"Our goal is to reduce the reporting burden by 50 percent. If we cando better than that, we will," he said.

Beatrice said regulations involving lot release information, contractmanufacturing, cooperative manufacturing arrangements anddesignation of the manufacturer's responsible head are all being re-written to reduce the compliance burden on manufacturers.

Regulations giving manufacturing more flexibility in the licensingprocess will be released within a few weeks. More liberal rules on lotrelease will be proposed within 12 months. Reducing reportingrequirements will be proposed in Sept. 1995. And regulationsreducing the standards for product establishment will be out beforethe end of 1995, Beatrice said. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.