FDA’s Center for Drug Evaluation & Research: 2016 Priorities

FDA’s Center for Drug Evaluation & Research (CDER) 2016 Priorities & Areas of Focus

Front Burner Priorities:

• Negotiate PDUFA 6 agreements
• Negotiate GDUFA 2 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 Sunscreen Innovation Act
• Continue implementation of 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, progress made, but more work 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  • Issue draft guidance on generic versions of abuse-deterrent opioid formulations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 Safe Use group
•  Improve staffing:
  • Continue to have more than 600 staff vacancies
  • Recruiting for multiple executive positions

Important Priorities:

*In no particular order

• Integrate Sentinel Network into routine drug safety activities
• Further implement biosimilars program, issuing additional guidance and launching educational efforts (Recent Senate hearing)
• Further implement statutory provisions related to the drug supply chain and “track and trace”
• Continue Drug Label Improvement Initiative
• Develop legal framework for Patient Medication Information (PMI) project
• Respond to outbreaks (ongoing)
• Develop a process and ultimate policy documents on evaluation of a biomarker as a surrogate endpoint for accelerated approval
• Develop a strategic plan for managing drug imports: progress made Full staffing and process standardization in re-organized Office of Compliance
• Continue to refine policies around personalized medicine; ongoing
• Continue to develop policy approach for antimicrobials to treat drug-resistant organisms
• Establish well-documented OPQ operations
• Ongoing assessment of impact of “Breakthrough Therapies” program
• Further implementation of qualitative benefit/risk assessment
• Modernize clinical evidence development, fully utilizing electronic health data (priority of Dr. Califf)
• Further advance patient-focused drug development program
• Evaluate the impact of requiring CV safety studies for certain chronic indications, e.g., diabetes and obesity (underway)
• Make significant progress on FDA-EU mutual reliance initiative
• Continue to push standards development and standardized electronic submissions
• Refine biomarkers qualification program
• Improve combination product Inter-Center review process
• Advance progress of the more than 22 consortia
• Work on ways to get drugs not supported by PREA/BPCA studied in children: new external pediatric network and neonatal consortium
• Develop implementation plan and training for pregnancy/lactation label rule
• Further develop use of Bayesian statistics, adaptive designs, modeling approaches, etc. for difficult drug evaluation issues

Continuing Priorities:

The following have been of high priority in the past and they are continuing to perform well:

• PDUFA and GDUFA processes: meeting the goals
• FOI : Reducing the backlog in the face of a higher request rate
• Advisors and Consultants: holding AC meetings
• OSE operations: multiple safety functions
• CDER research functions: well-organized, integrated with regulatory staff, and productive

Important Administrative/Managerial Priorities:

• Evaluation of CDER governance system: improvements underway
• Develop a more mature quality management system
• Implement CDER Diversity Plan
• Plan and implement a new time reporting system
• Continue to look at root causes for Employee Viewpoint Survey Results lowest scores (CDER generally gets excellent scores overall in this survey)

As stated by Janet Woodcock, MD, Director of CDER, at the FDA/CMS Summit for Biopharma Executives on December 14, 2015.