Woodcock Talks Up PDUFA, Increasing Staffing as Top Priorities

CDER Director Janet Woodcock sees PDUFA reauthorization and beefing up staffing as two top priorities that will occupy much of the FDA’s time over the next year.

Woodcock made this prediction during a podcast posted last week, during which she described the agency as strained in terms of staffing. Extra staff and resources are needed as negotiations for the next iteration of the PDUFA — as well as discussions about biosimilar and generic drug user fees — move forward.

She also noted that the FDA is interested in hiring to improve its OTC monograph process for reviewing nonprescription drugs. “If I could have 800 people on board this minute who aren’t here right now, I think we’d all be in a much better position,” Woodcock said in a wide-ranging interview on the FDA director’s corner podcast.

With the economy improving, Woodcock says it’s even “more challenging” for the FDA to hire qualified people. “We can’t compete with external salaries for the scientists and medical people and top executives and lawyers for that matter, and so we really are very down on people and that’s putting a strain on staff,” Woodcock said. “We’re going to have to push on hiring and also leadership development.”

Another top priority this year, Woodcock said, is the FDA’s focus on the prescription drug opioid epidemic.  She said companies can work on developing deterrent formulations, noting that the agency unveiled final guidance for drugmakers last year.

One of CDER’s key achievements last year was transforming its generic drug program and “getting it into a very high level of productivity,” Woodcock said.

Yet another major challenge, she said, was working with Capitol Hill on the proposed 21st Century Cures Act, which passed in the House and is pending in the Senate, with hearing scheduled for Feb. 9.

Read the transcript here: www.fdanews.com/01-22-16-transcript-woodcock.pdf.