Woodcock Announces CDER’s 2016 Priorities & Says ANDA Backlog was the Biggest Challenge of GDUFA I
On Monday, December 14th, the director of FDA’s Center for Drug Evaluation and Research (CDER), Janet Woodcock, M.D., spoke at the FDA/CMS Summit for Biopharma Executives where she announced the division’s top priorities for 2016.
Overview of 2015
Dr. Woodcock began by saying that the Agency has done “pretty well” throughout 2015. She also highlighted a number of the FDA’s accomplishments over the past year, drawing attention to many of the “front burner” priorities such as:
- Met and exceeded GDUFA performance goals
- Accomplishment of the stabilization of new Office of Generic Drugs (OGD)
- Completion of Standup of Office of Pharmaceutical Quality
- Completion of 2015 PAG agreement work
- Issued multiple draft and final guidances regarding pharmacy compounding
- Met all milestones related to the Sunscreen Innovation Act
- Responded to Congressional requests on ‘21st Century Cures’ legislation
In addition to the Agency’s successes, Woodcock also highlighted some concerns from 2015, such as the backlog of ANDAs. She stated that FDA experienced a “huge turnaround” this past year, and has exceeded its goals for GDUFA. Furthermore, she said the Agency is interested in reducing the number of review cycles for generic drugs currently trending at about four cycles per drug. , She declared that the ANDA backlog was the biggest challenge of GDUFA I, but stated that FDA is confident it will be able to get through the stockpile of generic applications within the next two years.
View a complete list of CDER’s 2015 priorities here.
Priorities for 2016
After touching on the successes of 2015, Woodcock dove into CDER’s goals for 2016. She provided an overview of what to expect in the coming year and highlighted a number of “front burner” priorities that CDER plans to tackle, including:
- Negotiate PDUFA VI and GDUFA II agreements
- Negotiate a second BSUFA program
- Continue to implement new (and clarified) statutory provisions on drug compounding and outsourcing facilities
- Continue to meet milestones of the Sunscreen Innovation Act
- Continue implementation of the Track and Trace program
- Respond (as needed) and participate (as requested) in Congressional inquiries and FDA-related legislative initiatives
- Re-evaluate the regulation of drug advertising and promotion in light of current jurisprudence around the 1st Amendment (ongoing; some progress has been made, but more work is needed.)
- Continue to plan for and build out Panorama for new drug review process and other regulatory functions
- Prescription opioid epidemic:
- Issue draft guidance on generic versions of abuse-deterrent opioid formulations
- Evaluate opioid labels and REMS
- Work on appropriate prescribing through the Safe Use group
- Improve staffing:
- Continue to have more than 600 staff vacancies
- Recruiting for multiple executive positions
Woodcock included additional concerns as well, categorizing them as “important priorities,” “continuing priorities,” and “important administrative/managerial priorities.” A full list of CDER’s 2016 priorities can be found here.
For more information on CDER’s goals and priorities for 2016, view Dr. Woodcock’s presentation here.