FDA TECHNOLOGY AND FACILITY SHORTFALLS HIGHLIGHTED BY ACTING COMMISSIONER BENSON BEFORE "BLUE RIBBON" COMMITTEE; "FUNDAMENTAL QUESTION" IS FDA MORALE

Deteriorating morale at FDA is a "fundamental question" that should be addressed along with the agency's hardware and facility needs, FDA Acting Commissioner Benson suggested in a briefing paper prepared for the FDA "blue ribbon" panel's first meeting on May 17-18. "Hardware and facilities aside, the fundamental question is how life in FDA has affected the self-image and morale of our personnel," Benson stated. After commending agency personnel for their "expertise, professionalism and high dedication," Benson added that "despite their devotion to public service, we see tell-tale signs of erosion." Benson noted that the increase in the amount of "public criticism and oversight" directed at FDA "has tended to create an aura of distrust and lower morale." The acting commissioner acknowledged that an "appropriate amount of oversight is necessary and beneficial," and in the case of the generic scanal "resulted in critical improvements in our generic drug review program that will serve the public good." However, Benson added that "the events of last year...have contaminated the atmosphere in which we work." He suggested that "unruly disruptive oversight" would lead to a situation where FDAers "are apt to become more disenfranchised." Benson warned that "these factors" would have a "pernicious effect on productivity and employee attitudes toward government service" and "diminish our ability to recruit and retain top-grade people." In addition to personnel, Benson also pointed out the increasing need for FDA to upgrade its information and scientific technology base, which is being compromised by the agency's lack of funding. He also highlighted the shortage of space at the agency and suggested that the "optimal solution" is the "consolidation of all of FDA's headquarters components at one location." While nearly all of the presentations by FDA center officials and top administrative personnel underscored FDA's lack of adequate resources, the issue of "user fees" was not brought up during the entire day-and-a-half inaugural meeting of the blue ribbon panel. However, several committee members questioned Benson about the resources issue. For example, former Kennedy staffer Lawrence Horowitz, MD, asked Benson if more resources would mend the agency's problems. Benson responded that it would not and that the agency needs to improve its credibility with the outside and its morale on the inside. Benson indicated that part of the agency's credibility and morale problems are related to the "lambasting" the agency has gotten recently in Congress. While emphasizing the value of oversight hearings to the agency and its processes, Benson suggested that "there's an optimal amount" of oversight and "in my view we've reached that." He noted that "we've been hit hard" on generic drugs and while the criticism is "appropriate," the process "in my view" needs "to be calibrated." Benson avoided committing himself on structural changes within the agency or on changes in the agency's mandate. When asked by Horowitz about structural changes, Benson answered: "I'm a strong advocate of change," but noted that structural changes "will happen" so "you don't necessarily start there." When Horowitz was a top staff aide to Sen. Kennedy during the 1970s, there was discussion of putting FDA's food and drug regulatory activities into two separate agencies. Committee Chairman Edwards asked if Benson could provide his thoughts to the committee later on restructuring, downsizing or relinquishing of some responsibilities. Center for Drug Evaluation and Research Deputy Director Gerald Meyer and Center for Biologics Evaluation and Research Director Paul Parkman, MD, both highlighted personnel shortages and lack of space as main problems. In his presentation on the situation at CDER, Meyer said the drug center has "a resource problem like everyone else." He noted that the workload is determined by outside factors and the center's "resources aren't indexed to it, whether it's space, whether it's FTEs (full-time equivalents, or personnel), whether it's dollars." A factor in CDER's personnel problem, Meyer said, is the inability to provide "competitive pay for scarce category professional staff." He noted that a starting pharmacokineticist receives between $20,000 to $40,000 more in an industry position than at FDA. Meyer stressed the importance of being able to recruit and retain top-notch medical reviewers, given the center's steadily increasing workload. CDER's current annual workload, Meyer told the panel, includes 119 new NDAs, 225 pending NDAs, 5,737 amendments/supplements, 1,057 new INDs, 9,500 active INDs, 784 new ANDAs/AADAs, and 1,191 pending ANDAs/AADAs. Also CDER has a full compliance agenda: two injunctions, 33 seizures, 203 regulatory letters and 319 recalls. The CDER deputy director pointed out that the center expects a significant influx of INDs in the future as a result of the pharmaceutical industry's exponential increase in R&D spending. In addition, Meyer noted that 185 drugs, including a number of breakthrough compounds, will be coming off patent by 1995 resulting in a deluge of ANDA applications for the Office of Generic Drugs. Despite the problems, Meyer indicated that CDER as a whole is well. "We make good decisions. We very seldom find substantial disagreement about our decisions on the safety and effectiveness of a product." In addition, he said that the agency has made a "significant" reduction in the NDA backlog: "We've gone from an overdue backlog of 165 applications in 1985 to 67 last Dec. 31," Meyer told the panel. Meyer also provided the panel with CDER's list of responsibilities in order of priority. On the top of the list were facilitating new AIDS drugs on the market and shortening the review time of NDAs by meeting with industry sponsors during development. Panel member Richard Merrill, a former FDA chief counsel currently at the University of Virginia School of Law, questioned the high priority given by Meyer to helping companies prepare NDAs and noted that the agency of the 1970s would not have recognized the same responsibility. Asked by a panel member whether CDER expects to see changes in the traditional categories of drugs it reviews, CDER Director Carl Peck said the agency is reviewing what it thinks "are likely prescription drugs that will be, that should [be], or are being considered for OTC use." He said that FDA is "rethinking our traditional approach to that and how we should manage that for the future." Peck added that "we have at the moment over 40 NDAs at various levels of electronic submission. You could call all of these experiments because no two are alike...We are in an aggressive planning and training mode to encourage the transfer of the formerly many linear feet of paper that the agency receives to electronic media." In a "best scenario" presented to the committee, Meyer said FDA "would like to have an industry who can submit applications in the latest electronic format available, [so] we can review those applications in concert with academic colleagues...in a thoughtful way, and we can translate that into an expedited approval process. And that we can do that in the context of a staff that is well-based, well-housed with opportunities for both laboratory and clinical research." CBER's Parkman, who will be retiring from FDA in July, told the committee that his center also faces the challenges of recruitment and retention problems and the lack of working space. Parkman also expressed his frustration with the bureaucratic processes involved in procurement and promulgating regs. CBER also is facing growing responsibilities and public pressure from the AIDS epidemic, Parkman noted. He pointed out that the Public Health Service estimates that "over 365,000 [AIDS] cases will be reported by 1992" and that the public wants FDA to make AIDS products available before approval. In addition to AIDS, CBER is also faced with increased regulatory and approval responsibilities from the rapidly growing biotechnology industry. Like CDER, the workload at CBER is steadily increasing, Parkman reported. The FDA official noted that from fiscal year 1985 to 1989, the number of active INDs in the biologics area has increased 89%. The center projects that by FY 1991 the amount of active INDs will increase by 134%. Parkman provided a glimpse of biologics' resource/workload history for non-AIDS activities from FY 1973 to 1989. During that timespan, the number of active INDs increased 406% (from 411 to 2,080), and operating dollars increased 2% (from $6.4 mil. to $6.6 mil.), while the number of FTEs decreased 1%. In the biotech area, Parkman noted that product applications have increased over 135% during the last four years. He added that over 50% of all new INDs received are for biotechnology-derived products. Parkman addressed some of the ways in which CBER has dealt with its problems. In order to accommodate the large number of AIDS-related applications, CBER "reprioritizes workload" to divert personnel to cover those activities. The center reprogrammed its resources by breaking out a new division for cytokines and is currently developing a new one for hematology products. CBER is trying to improve internal procedures by starting a training program to increase the efficiency of its review staff and looking at computerization of submissions. Meyer and Parkman were among a group of FDA officials, including Benson and representatives from each of the centers, that presented during the two-day session. The major thrust of the presentations was the agency's shortage of manpower, lack of adequate facilities and lack of funds. Regarding FDA's facilities problem, Office of the Commissioner Chief of Staff Joseph Levitt said FDA has "received support from many quarters for the concept for a consolidated FDA Washington area campus...we are now working directly with the General Services Administration in developing a program of requirements for such a facility." FDA's Office of Regulatory Affairs is also facing manpower and resource problems. The office's associate commissioner, Ronald Chesemore, pointed out that some of his district offices are experiencing a high rate of turnover in investigators and that the field labs are working with 10-year old equipment. He noted that his office needs to implement "a field-wide automated information system on imports" in order to be able to interact with other agencies.