FDA Office of Pharmaceutical Quality Issues Their Annual Report

On February 28, 2018, FDA’s Office of Pharmaceutical Quality published their first public annual report describing their 2017 accomplishments.  The report discusses the implementation of a number of user fee programs, an overview of quality assessments completed in 2017, a summary of 2017 accomplishments related to key quality initiatives such as the emerging technology team and the New Inspection Protocols Project (NIPP), 2017 guidance documents issued, and OPQ’s involvement in 2017 facility preapproval inspections.

2017 OPQ activities and accomplishments that are captured in this annual report include the following:

  • Completed implementation of a new set of user fee programs (PDUFA VI, GDUFA II, BsUFA), including training of OPQ personnel to help meeting the commitments in these reauthorised user fee programs.
  • Deployed more than 100 OPQ staff to respond to hurricanes Harvey, Irma, and Maria.  OPQ continues to monitor potential short- and long-term drug shortages in these disaster zones.
  • Conducted quality assessments contributing to the approval or tentative approval of the following:
    • 132 new drug applications, including 13 breakthrough therapies
    • 1,027 generic drug applications, including 150 priority first generics
    • 21 biologics applications, including 7 breakthrough therapies and 5 biosimilars
  • Accepted 19 Emerging Technology Team (ETT) meeting requests and held 20 ETT meetings.
  • Initiated a third pilot for NIPP inspections at sterile drug process facilities, and developed a work plan for expanding the NIPP approach to additional dosage forms.
  • Provided an Experiential Learning Site Visit Program for 330 OPQ staff to visit 17 pharmaceutical companies across the U.S.  Note that AbbVie was selected for this program and hosted approx. 20 OPQ personnel in September 2017.  OPQ has requested more industry participants for this program in 2018, and AbbVie has submitted a proposal for consideration in the 2018 program.
  • Participated or led 108 pre-approval inspections for NDAs, ANDAs, or BLAs.
  • In 2017, FDA launched a new effort to make its facility inspections more efficient.  The was called “ConOps”, or concept of operations.  OPQ worked with internal FDA ConOps partners to develop templates for decisional letters to communicate final inspection classifications within 90 days of the end of surveillance, post-approval and for-cause inspections.  These 90-day letters have begun to roll out to facility owners.
  • Expedited 45 ANDAs, 25 ANDA supplements, 2 BLA supplements, and 43 NDA supplements due to drug shortages.
  • Contributed to over 150 peer-reviewed articles.

The report also stated that improved inspection coverage is being achieved by FDA by executing a surveillance plan that aims to inspect all previously uninspected sites (foreign and domestic) by the end of FY 2019.  Additionally, in early 2018, OPQ will be issuing a 2018-2022 Strategic Plan that will include priorities, objective and performance goals over the next 5 years.

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