FDA's Quality Office Touts Achievements in Second Year

Posted 01 March 2018 | By Michael Mezher 

FDA's Quality Office Touts Achievements in Second Year

In its first ever annual report, the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality (OPQ) says it met its performance objectives while working to implement new programs in a challenging year.

FDA first launched OPQ in 2015 to standardize and centralize its oversight of drug quality for both foreign and domestic manufacturers.

On top of implementing a new set of user fee programs in 2017, OPQ Director Michael Kopcha says that more than 100 of his staff of 1,300 were deployed as part of FDA's response to hurricanes Harvey, Irma and Maria.

"OPQ continues to monitor potential short- and long-term drug shortages in these disaster zones," Kopcha says.

2017 Activities

As part of its routine operations, OPQ conducted quality assessments for 132 new drug applications (NDAs), 1,032 abbreviated new drug applications (ANDAs) and 21 biologics license applications (BLAs) in 2017.

Among those were 13 NDAs and seven BLAs with breakthrough therapy designations, five biosimilars and 150 first generics.

In response to potential drug shortages, OPQ says it expedited the quality assessments for 115 ANDAs and ANDA, BLA and NDA supplements.

While FDA's Office of Regulatory Affairs (ORA) carries out most pre- and postapproval inspections of drugmakers' facilities, OPQ says its staff participated in or led 108 of the 304 preapproval inspections FDA conducted in 2017.

In 2017, FDA launched a new effort to make its facility inspections more efficient, dubbed "ConOps" or concept of operations, which OPQ contributed to through the development of new templates for 90-day decisional letters sent after the conclusion of surveillance, postapproval and for-cause inspections.

OPQ also released ten draft and final guidances in 2017, covering topics such as the use of nanomaterials in drugs and biologics and the pre-submission of facility information for priority ANDAs. The office also released or updated ten internal manual of policies and procedures (MAPP) documents, covering issues such as evaluating emerging technologies and managing drug shortages.

Additionally, OPQ says its staff worked on more than 150 peer-reviewed articles published in 2017 focusing on technical issues related to drug quality, including challenges related to biosimilars.

As for its plans going forward, OPQ says it aims to release a five-year strategic plan for 2018-2022, detailing the office's priorities and performance goals over the course of the current user fee agreements.


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