ANDA Backlog, OPQ, Abuse-Deterrent Opioid Guidance Are Among CDER's Top ’15 Priorities

Addressing the ANDA backlog, setting up the pharmaceutical quality office, and issuing final guidance on abuse-deterrent opioids are among the roughly dozen top priorities for CDER in 2015.

CDER Director Janet Woodcock outlined the office’s 2015 plans in an internal presentation given to agency staff, and many are continuations of projects started in 2014.

One of the most prominent projects to carry over from last year is implementing the GDUFA review goals that went into effect Oct. 1; once completely implemented the goals require the FDA take action on 90 percent of ANDAs within 10 months of submission. Meeting the GDUFA goals depends in part on the new IT system that manages electronic ANDAs, and Woodock says the ANDAs filed since the system went live are on track to meet initial review goals. The agency will continue to refine the new system as part of the GDUFA implementation efforts next year, she added.

Starting up the Office of Pharmaceutical Quality (OPQ) on Jan. 11, 2015, represents another top-tier priority, Woodcock said. Particularly important for OPQ, which will be the office in charge of all drug safety issues, will be implementing its manufacturing metrics collection program to evaluate the quality status of all drug facilities selling into the U.S.  

Another key priority in the quality realm will be integrating the Office of Regulatory Affairs’ pre-approval facility inspections into the OPQ team review so that drug manufacturers receive more standardized quality assessments, she said.

Additional front-burner priorities include reexamining agency policy on drug advertising and promotion, which comes in light of the 2012 Caronia decision in the U.S. Second Circuit that found off-label promotion was protected by free speech, participating in the 21st Century Cures Congressional roundtables to shape future drug regulation, responding to the Ebola outbreak and filling more than 600 job vacancies at the agency.

Secondary, important priorities laid out by Woodcock include implementing the biosimilars program, refining the agency’s drug safety program, implementing drug track-and-trace regulations and improving the breakthrough therapy designation program.

Refining personalized medicine policies also drew considerable attention in the presentation. This will be done in part through continuing efforts to engage with and collect knowledge from patient and non-profits groups, Woodcock said.

Ongoing priorities for CDER include continuing to meet the goals of PDUFA and reducing the freedom of information request backlog.

See the presentation here: www.fdanews.com/12-19-14-CDER-2015-Priorities.pdf. – Bryan Koenig