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FDA’s Drug Approval Team Copes With 700 Unfilled Jobs

Pharma companies lure staff away

The FDA 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, according to a report from Kaiser Health News.

“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 recently at a rare-diseases summit in Arlington, Virginia.

The FDA has been under fire for taking too long to approve new drugs, despite clearing a record number of generic medications in 2015. Although the agency 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 September 30, the Kaiser article notes. And the CDER itself had 711 openings out of 5,525 positions at the end of September, according to spokeswoman Theresa Eisenman—meaning that more than one out of eight positions was empty.

Most openings have occurred as the result of new laws or initiatives that increased the FDA’s workload and created new positions. The agency has had a difficult time accelerating its hiring in response, and the pace has picked up, Eisenman said. The CDER continues to use employees borrowed from elsewhere within the FDA and contracts workers to help fill the breach.

In addition to lower federal salaries, Woodcock said new employees must divest any stock they have in companies related to food or drugs before they begin working at the FDA—and that can similarly deter good candidates.

The 21st Century Cures Act, which passed the House in 2015 and has not yet been approved by the Senate, could help the agency meet its hiring goals. A portion of the multibillion-dollar bill would amend existing laws to make FDA postgraduate degree requirements less strict for some positions.

The bill also would allow the FDA to offer higher pay without prior approval from the executive branch, as long as the amount is less than the president’s $400,000 annual salary. The FDA has starting salaries of up to $160,300 per year, according to listings on 

House Speaker Paul D. Ryan (R-Wisconsin) said in September that the legislation would be on his to-do list when Congress returns to work this month. How to pay for it remains a major issue, however.

Source: Kaiser Health News; November 3, 2016.

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