WASHINGTON _ Kathryn Zoon, director of FDA's Center forBiologics Evaluation and Research (CBER), said on Monday thatCBER has hired 165 new employees since October 1992 under theterms of the Prescription Drug User Fee Act. The new hirees include 90reviewers and 20 medical officers, as well as support staff.Zoon provided the updated figures to attendees of the Food and DrugLaw Institute's annual Biologics Update. The CBER hirings are acritical part of the FDA's plan to shorten product license application(PLA) and establishment license application (ELA) review times, asrequired by the 1992 user fee legislation.In total, the FDA is authorized to employ about 700 new drugreviewers and support staff by the end of fiscal 1997 (the FDA's fiscalyear runs from Sept. 1 through August 31). About half of the new hireswill accrue to CBER and half to the Center for Drug Evaluation(CDER), unless differing workloads at the two divisions warrant aweighted distribution. The personnel expansions will be fundedentirely by the user fees levied on approximately 175 pharmaceuticaland biotechnology companies.The number of qualified and trained reviewers is considered the key toaccelerating PLA and new drug application (NDA) review times. "Youcan bring lots of new people on board but without training, they can'tdo their jobs," said Zoon, adding that aggressive reviewer trainingprograms are currently underway at CBER.Zoon chronicled the FDA's recent progress toward achieving otheruser fee program goals, such as eliminating the backlog of existingapplications. She said that the backlog of PLAs and ELAs at CBER hasbeen a top priority in the last year. In addition, CBER has focused onclearing out effectiveness and manufacturing supplements.According to Zoon, as of Oct. 1, 1992, there were 25 ELAs and 26PLAs in CBER's backlog that were covered by the user fee program.As of June 30 this year, the FDA had taken final actions on all of theELAs and 24 of the PLAs. Surprisingly, 18 of the ELAs and 16 of thePLAs were withdrawn by the sponsors."There was a high number of withdrawals," noted Zoon. "It appears wehad a lot of old dogs at the Center (CBER) and there were very fewapprovables in the backlog cohort. Indeed, only two of the 26backlogged PLAs were approved by FDA while none of the 25backlogged ELAs were approved.As of Oct. 1, 1992, there were 232 manufacturing supplements inCBER's backlog and six effectiveness supplements. By June 30 thisyear, those numbers had been reduced to zero and seven, respectively.Again, a high percentage of supplements were withdrawn by theirsponsors for various reasons.The user fee law sets a six-month deadline for FDA review of"priority" applications and a 12-month deadline for review of"standard" applications. ("Priority" applications are for drugs offeringsignificant advances over existing treatments.) Zoon pointed out thatFDA doesn't have to meet those standards until 1997. Even so, shemeasured CBER's performance in 1993 and 1994 to date using the1997 standards.Zoon said that in fiscal 1993, CBER received 10 ELAs and 10 PLAs.The division met review deadlines on 75 percent of ELAs and 86percent of PLAs. CBER scored lower on review times formanufacturing and effectiveness supplements, meeting reviewdeadlines for those two submission types only 50 percent of the time.In fiscal 1994 to date, CBER has received six ELAs and six PLAs.Although review deadlines haven't kicked in yet for all thesubmissions, not a single one is yet overdue, said Zoon. In addition,Zoon said the number of applications receiving a "refusal to file"(RTF) rating from CBER decreased slightly in 1994, suggesting thatcompanies are preparing their PLAs and ELAs more knowledgeablyand carefully. (A submission that receives an RTF rating is deemed byFDA insufficient for agency review. Manufacturers can appeal an RTFthrough the FDA's chief mediator and ombudsman's office.)AIDS Researcher Warns Against Price ControlsA top AIDS researcher told journalists at a news conference Mondaythat drug price controls could have a chilling effect on the developmentof new drugs to treat AIDS.Paul Volberding, director of the Center for AIDS Research, professorof medicine at the University of California at San Francisco and chiefof the AIDS program at San Francisco General Hospital, said that theprice for cheaper drugs may be fewer drugs."We obviously need more drugs for HIV in this epidemic," saidVolberding. "And yet, some major companies have announced thatthey don't feel that AIDS provides them enough chance for success indrug development to warrant their involvement. It seems to me that inhealth care reform we must pay attention to that."Volberding cited Indianapolis-based Eli Lilly & Co.'s recent decisionto drop all active programs in AIDS drug development as typical ofcurrent sentiment in the pharmaceutical industry. He said that privatesector research is the main engine behind AIDS drug discovery,research and development, and federally funded programs cannot fill inthe gap if drug companies abandon the effort. Volberding blamed thedecline in AIDS drug development on uncertainty over health carereform and the politics of AIDS."AIDS is a very political disease," said Volberding. "The ability of adrug company to control the development of a drug is threatened withthis epidemic. There are a variety of reasons for uncertainty, butcertainly not knowing the final result of health care reform has got tobe a major one."Volberding was in Washington to attend a meeting of the AIDSClinical Trial Group, a group of researchers who conduct clinicalresearch. He is also a member of Bristol-Myers Squibb Physicians'Panel on Health Care Reform, described in a statement as "a group ofphysicians speaking about health care reform from the perspectives ofresearch and patient care." n

-- Lisa Piercey Washington Editor

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

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