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December 18, 2015.
The front-burner assignment for drug regulators in 2016 is to negotiate new user-fee agreements for drugs, generic drugs, and biosimilars; one of many important tasks for FDA set by Congress, reports Janet Woodcock, director of the Center for Drug Evaluation (CDER). Woodcock’s priority list for 2016 highlights the need to further implement other legislative mandates such as drug compounding, track-and-trace, and sunscreen oversight, she explained at the FDA/CMS Summit on Dec. 14, 2015. And CDER officials will continue to spend considerable time responding to inquiries from Capitol Hill involving FDA-related legislative initiatives, such as the “21st Century Cures” proposal and its counterpart under development in the Senate.
Other important CDER assignments are to re-evaluate drug advertising and promotion in light of recent court decisions involving the first Amendment and to continue to deal with the prescription opioid epidemic by encouraging abuse-deterrent formulations and promoting safe prescribing. Woodcock also highlighted the importance of a smooth-running CDER operation, noting continuing efforts to implement the new “Panorama” IT system for managing drug review and regulatory functions. To accomplish all these tasks, she stressed the need to fill approximately 600 staff vacancies in CDER, a situation aggravated by outdated curbs on FDA salaries and cumbersome recruitment policies.
Woodcock cited CDER’s hard work to improve the generic-drug approval process, which will continue to take steps to minimize multiple review cycles. The new Office of Product Quality has been established, and its staff will strive to develop quality metrics and prepare for a major overhaul of the FDA field inspection program for new therapies and manufacturing facilities. Streamlining clinical trials will involve multiple projects, Woodcock said, including new IT systems and improved approaches for study monitoring and ensuring data quality. CDER will evaluate further the breakthrough therapy program, update the patient-focused drug development initiative, and continue support for personalized medicine development. Woodcock’s priority list for 2016 is long and comprehensive, as can be seen in her full presentation.