Woodcock: FDA Must Hire Specialists to Implement PDUFA VI, 21st Century Cures

The FDA will have to staff up and hire new kinds of scientists to fully implement the provisions of the 21st Century Cures Act and the next generation of user fee agreements, according to FDA leadership.

Testifying on Capitol Hill, CDER Director Janet Woodcock told members of Congress that pursuing real-world evidence and patient-focused drug development will require the agency to hire more big data analysts and social scientists.

“That’s one category we don’t necessarily have enough of,” said Woodcock, before the House Energy & Commerce health subcommittee, on the sixth reauthorization of PDUFA coming this year. Evaluating high-tech treatments, such as novel gene and cell therapies currently under development, will also require qualified reviewers, she said.

In addition, the agency will look to hire rare disease specialists, as the Cures Act directs the FDA to create interagency centers that focus on specific diseases, and direct relevant product approvals. The FDA recently established its Oncology Center of Excellence, which includes oncologists in the coordination of product reviews across CDER, CBER and CDRH.