By Sydney Lupkin and Sarah Jane Tribble
The Food and Drug Administration has more than 700 job vacancies in its division that approves new drugs, and top officials say the agency is struggling to hire and retain staff because pharmaceutical companies lure them away.
“They can pay them roughly twice as much as we can,” Janet Woodcock, who directs the FDA’s Center for Drug Evaluation and Research (CDER), said at a rare-diseases summit recently in Arlington, Va.
The FDA has been under fire for taking too long to approve new drugs, despite approving a record number of generic drugs in 2015. Although it met its goal of hiring 1,000 new employees to help clear the backlog of unapproved generics, that program had nearly 200 job vacancies as of Sept. 30. And CDER itself had 711 openings out of 5,525 positions at the end of September, according to spokeswoman Theresa Eisenman — meaning that more than 1 out of 8 positions were empty.
Most openings have occurred as the result of new laws or initiatives increasing the FDA’s workload and creating new positions. The agency has had a difficult time accelerating its hiring in response, but the pace has picked up, Eisenman said. CDER continues to utilize employees borrowed from elsewhere within the FDA and contract workers to help fill the breach.
Should the center not come much closer to full strength, said panelist Peter Saltonstall, president and chief executive of the National Organization for Rare Disorders, the FDA won’t be able to speed approval of orphan drugs.
“Do the math, folks. . . . You are talking about trying to get things expedited and move more quickly with that many openings?” Saltonstall said.
[FDA grants accelerated approval to controversial muscular dystrophy drug ]
Woodcock wrote in December that staffing was a priority in 2016 because the center had “more than 600 staff vacancies.” At the Arlington event, she called the federal hiring system “challenging,” adding that prospective candidates often take other jobs while waiting for the FDA to make an offer.
“We move rather slowly — like a snail might be a better analogy,” agreed Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “A young person with a family can’t wait four months for us to get through some of the federal hiring process. So if they have something else that’s more . . . expedient, they will take that.”