WASHINGTON _ The FDA's embryonic effort tooverhaul and standardize its clinical and statistical reviewpractices has begun to acquire discernible shape in thelast few weeks. Center for Drug Evaluation and Research(CDER) director Janet Woodcock told reporters onTuesday that she hopes the first concrete products of theso-called Good Review Practice (GRP) initiative will bepublicly available within six to nine months.

Those documents, written guidelines for the 450-plusclinical and statistical reviewers at the Center forBiologics Evaluation and Research (CBER) and theCDER, could speed and improve review procedures forinvestigational new drug applications (IND), new drugapplications (NDA) and product license applications(PLA). In addition, the highly technical GRP texts will beof keen interest to industry since they could provide aninsider road map of sorts for the regulatory reviewprocess.

"The GRP initiative will provide advice to us internally,but it will also provide advice to be read by the regulatedindustry," explained Robert Temple, director of CDER'sOffice of Drug Evaluation I who joined Woodcock in aninformal press conference called to discuss the GRPproject.

Woodcock cautioned that GRP guidelines will not be a"recipe" for regulatory review but rather "a treatise oncooking" that could aid all participants in the process.She has made the GRP initiative _ first conceived at aCDER management retreat in 1991 _ a top priority sincetaking her current post about six months ago.

Ultimately, the FDA's GRP initiative, as described in aNov. 3 press backgrounder, has the lofty goals of"advancing the state-of-the-art of review" at the FDA andproducing "an evolving, interactive and flexible processof improving review practices and systematicallydeveloping a science of review." The project gatheredsteam after the Prescription Drug User Fee Act passed in1992, lighting a statutory flame under the agency's feetfor more timely reviews of NDAs and PLAs.

The idea behind GRPs, according to Temple, is to createa credible, publicly available standard describing theentire review process to be used by new and experiencedreviewers at the FDA, industry sponsors of drugs and thepublic. The effort has been divided into 11 so-called"tracks," or areas of focus, headed by various agencyofficials.

Although the GRP initiative is couched in the arcanelanguage and organizational schemes of bureaucracy, itcould yield critically relevant nuts-and-bolts directionsfor companies developing drugs.

A Common Understanding

For example, the group of FDA experts spearheading"track four" will work to develop a commonunderstanding of "developmental review practices" (i.e.,issues relating to the pre-IND stage, INDs, and all themeetings and milestones that lead to NDAs and PLAs).Headed by Jay Siegel, director of CBER's Clinical TrialDesign and Analysis Division, the group will ultimatelywrite guidelines for the all-important industry-agencymeeting that takes place at the end of Phase II trials,before a Phase III trial is launched. The ultimate productof track 4 could include a detailed "checklist" of items forreviewers to discuss with companies and guidance forwhat issues should be explored in-depth.

Another group, headed by Woodcock herself and labeled"track 2," will strive to develop a framework for the FDAto incorporate "feedback, evaluation, evolution andchange" into its review process on an ongoing basis.Track 2 team members will attempt, among other things,to set up a "robust, interactive" peer-review process forevaluating data, gather a collection of reviews that areconsidered prime examples of the process at its very best,and promote the development of "regulatory science" byencouraging research and discussion of innovativeclinical trial design and analysis.

The GRP initiative was first announced to CDER staff ata meeting in September but the organizational structurethat will drive the project was unveiled on Nov. 21 at agathering of 600 CDER and CBER clinical and statisticalreviewers and other FDA employees. In breakoutsessions at that meeting, section heads such as Woodcockand Siegel laid out the broad focus areas of the GRPeffort.

"This initiative will reflect expert thinking and willproduce a technical manual," said Woodcock. "Reviewersare concerned that GRP guidelines not be a straight jacketbut they also want to know, `When am I done? Howmuch review is needed?' and these guidelines will helpanswer those questions." Woodcock added thatunnecessarily lengthy FDA reviews are not a "good useof taxpayers' money," a view which is enthusiasticallyshared by many of the Republican members of Congresswho have recently ascended to chairmanships ofCongressional committees with FDA oversight authority.

The GRP initiative will be coordinated with other agencyefforts to streamline the drug approval process, includinguser fee programs, the Computer Assisted New DrugApplication (CANDA) program and the SubmissionManagement and Review Tracking (SMART) program.A steering committee composed of CBER and CDERstaff will meet bimonthly to discuss staffing, resourcesand implementation of the initiative. n

-- Lisa Piercey Washington Editor

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