WASHINGTON _ When the FDA's Center forBiologics Evaluation and Research (CBER) kicks off thebeginning of its fiscal year next Monday, it will have toredouble its efforts to review and act on applications frombiotech manufacturers to make sure product reviews arecompleted within the time limits set by the agency. In allreview categories, the center has set stricter review timetables than those specified during the last fiscal year.

Shortening review times is one of the FDA's five goalsidentified to accomplish its strategic plan. The FDA is"committed to reducing the review time for priorityapplications to within six months of submission and thereview time for standard applications to within 12 monthsof submission," according to an FDA report to Congress.The regulatory timetables are detailed in the FDA's"Justification of estimates for appropriations committees"submitted to Congress annually.

The Republican-controlled Congress already appearsintent on keeping close track of how well the FDA meetsits deadlines for conducting product reviews. In hearingsheld earlier this year, the House Commerce Oversight andInvestigations Subcommittee, chaired by Rep. Joe Barton(R-Tex.), made a point of faulting the FDA for havingreview times that were longer than those of regulatoryagencies in other countries. (See BioWorld Today, July27, 1995, p. 1.)

For the next fiscal year, CBER has committed its staff tomeeting the following goals, including:

* Review and act on 80 percent of product licenseapplications, establishment license applications and newdrug applications that are designated standardapplications within 12 months after their submission.

* Review and act on 80 percent of efficacy statementsand amendments within 12 months after their submission.

* Review and act on 80 percent of manufacturingsupplements, and amendments within six months ofsubmission.

* Review and act on 80 percent of completed applicationsresubmitted following receipt of a not approvable letterwithin six months after the resubmission date.

CBER defines `act on' as "the issuance of a completeaction letter after the filing of an application." The FDAissues three types of action letters, including approvalletters, approvable letters and not approvable letters.

The FDA estimates that Congress will have toappropriate an additional $2 million to CBER's currentbudget of $143 million in order to expand its staff by 35additional positions in order to meet the review timetable. Overall CBER operations will shrink slightly infiscal 1996 as the number of full-time equivalents isreduced by 23 or 2.4 percent.

With the start of the fiscal year on Oct. 1, 1995, CBERalso plans to begin work on a gene therapy registryinformation system as a project under FDA's SubmissionManagement and Review Tracking program. The registrywill be an automated systematic record of demographic,clinical outcomes and safety data for all genetic therapyregistry patients in the U.S. n

-- Michele L. Robinson Washington Editor

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