FDA Launches Difficult Search For Recently Authorized Drug Reviewers

United States Food and Drug Administration officials were, understandably, pleased late last year when Congress authorized the agency to hire 600 new drug reviewers. Additional staff, FDA officials contended at the time, would be bound to reduce-- perhaps by as much as half--the time required for pharmaceuticals to move through the agency's review process and, thus, make great inroads in relieving FDA's long-criticized "biotech bottleneck." Now, however, the edge of optimism among the officials has been dulled a bit, as they realize that they may have some trouble finding and hiring the right scientists to fill those 600 open positions. Attracting the new reviewers, who will be financed through user fees levied on pharmaceutical and biotechnology companies, will be difficult, they say. For one thing, no new employment incentives are being offered. In addition, there are the usual drawbacks of goverment and FDA employment: the bureaucratic red tape involved in getting a federal job, the enormous load of paperwork reviewers must deal with, and the low pay offered to qualified candidates. Nonetheless, FDA officials say, they are aggressively scouring academia, medical research facilities, and industry in search of scientists and physicians with the necessary credentials, including a less-tangible qualification--a commitment to public service. "You visit universities, you contact people, you network," says Gerald Meyer, deputy director of FDA's Center for Drug Evaluation and Research (CDER), which will employ half the new reviewers. "You be as aggressive as you can, and you tell them public service is worth the sacrifice." Many of those people are self-selecting, adds Mary Jo Veverka, FDA's senior adviser for management and systems. "Everyone knows that FDA is buried in paper, but there is a real sense of mission and commitment and value that is being given to the patient," she says. "It's an exciting time to be at the agency, but you wouldn't stay without that commitment." The new reviewers will be phased in over a three-year period after a statute is passed this spring that allows FDA to collect user fees from pharmaceutical companies to review their drug applications. The enabling legislation, the Prescription Drug User Fee Act, a joint effort of FDA and the drug industry, was approved last fall; only a minor statute that details the way the funds are collected remains to be approved early in this congressional year. The statute is regarded by FDA as housekeeping, sure to win passage. The estimated $330 million that will then be collected over five years from the fees will help FDA speed up the drug review process; in fact, agency officials have promised by 1997 to cut review time from an average 23 months to 11 months. Higher- priority drugs will take half that time. That is, of course, if the FDA can attract the staff it needs. The job description calls for reviewers to have experience in a variety of medical and scientific disciplines and to be familiar with the conduct of scientific research and procedures in the medical community. All will be charged with reviewing clinical and laboratory data and rendering expert judgment on the safety and efficacy of new pharmaceuticals. They will be almost equally split between CDER and the Center for Biologics Evaluation and Research (CBER), the agency's two reviewing arms, both in Gaithersburg, Md. The needs for CDER and CBER have recently been defined, based on the agency's current backlog and its present and future application load. CDER, which already has more than 1,400 reviewers, wants to hire 40 physicians, 22 pharmacologists, three pharmacists, 25 consumer safety officers, 36 chemists, 11 statisticians, and numerous technical and administrative support personnel. CBER is smaller, but it is growing faster than CDER, and so it needs just as many new reviewers of about the same mix. Hardest to find will be physicians, who are often highly paid in the private sector, and chemists, who often make $20,000 more a year in industry, says CDER deputy director Meyer. But FDA's tough work also is its drawing card, he says. "I find we appeal because we offer the best training in the world. Reviewing potential drugs can be one of the most extraordinary, demanding jobs these people can have," says Meyer. Agency officials say they expect to find these people among the ranks of the newer doctoral graduates, hungry for an interesting job, and older professionals, who seek new challenges. As an example of the latter, FDA officials point to physician- scientists like Roger Williams. An M.D. and a professor of pharmacology and medicine, Williams left the University of California at San Francisco in October 1990 to come to suburban Maryland and work for FDA. He was 50, and he took a sizable slice in pay. But he says he has never been happier. "I really have loved every minute," says Williams, director of FDA's generic drugs division. "I was financially secure and felt it was time to give something back. My reward has been a tremendous feeling of challenge and accomplishment." Renee Twombly is freelance writer based in Durham, N.C.

FDA Launches Difficult Search For Recently Authorized Drug Reviewers

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