By Barbara Unger, Unger Consulting Inc.
FDA recently published its enforcement statistics for FY2017, a practice that started with the publication of FY2009 data. The metrics provide a high-level overview of enforcement actions — including injunctions, seizures, warning letters, and recalls — conducted by all FDA Centers. This posting will look at data from the enforcement metrics in two ways:
Data used to construct the Figures 1 through 5 below are taken directly from the FDA slide decks of enforcement actions from 2008 through 2017. The figures do not, however, appear in the FDA slide decks. All data are in fiscal years (FY).
Fig. 1 shows the combined number of CDRH product seizures and injunctions, which varied between 0 and 2. CDRH had no injunctions or seizures in 2009, 2014, and 2017.
Fig. 2 shows that warning letters issued by CDRH increased slightly between 2010 and 2013 (with a dip in 2011), followed by a dramatic decrease in FY2014, another increase in 2015, and decreases again in 2016 and 2017. Please note that these data do not exclusively represent GMP warning letters, but include all warning letters issued by CDRH. The decrease in 2017 also reflects the decrease in warning letters for advertising, which have all but disappeared.
Fig. 3 shows that CDRH’s average number of recall events between 2008 and 2017 is 1,080, and ranges in value between 776 and 1,283. The number of CDRH-recalled products averaged 2,709, with a range in value between 2,304 and 3,226.
Fig. 4 shows the number of CDRH Class I recall events per fiscal year between 2010 and 2017 has consistently hovered around 50. It also shows that the number of CDRH Class I products recalls increased from 2009 through 2011, decreased precipitously in 2012, increased again in 2013 and 2014, and then continued to decrease through 2017.
The question often arises whether Class I recalls as a percentage of total recalls is increasing over time. When considering CDRH Class I recall events as a percentage of the total of CDRH recall events, Fig. 5 shows that values remain consistent between 4 percent and 6 percent, with a low of 2 percent in 2008.
For CDRH Class I recall products as a percentage of total CDRH-recalled products, the values increase between 2008 and 2011, and then decrease by approximately half in 2012. From 2012 through 2014, they increase again to the levels of 2010 and 2011, but then decrease in 2015, 2016, and 2017. This variability may simply represent normal fluctuations, given the small numbers, but it is something we will monitor in the future.
It’s always interesting to use the past as a roadmap for the future. This year, with the new administration in the White House, it is a bit more complicated. The current administration has worked to diminish regulations, but its approach to enforcement actions remains unclear.
Time will tell; it will be a wait-and-see situation, and enforcement trends may continue as they did in 2017. Stay tuned — we will monitor these trends and let you know what we see, read, and ultimately find in the FY2018 enforcement metrics.
About the Author:
Barbara Unger formed Unger Consulting, Inc. in December 2014 to provide GMP auditing and regulatory intelligence services to the pharmaceutical industry, including auditing and remediation in the area of data management and data integrity. Her auditing experience includes leadership of the Amgen corporate GMP audit group for APIs and quality systems. She also developed, implemented, and maintained the GMP regulatory intelligence program for eight years at Amgen. This included surveillance, analysis, and communication of GMP related legislation, regulations, guidance, and industry compliance enforcement trends. Barbara was the first chairperson of the Rx-360 Monitoring and Reporting work group (2009 to 2014) that summarized and published relevant GMP and supply chain related laws, regulations, and guidance. She also served as the chairperson of the Midwest Discussion Group GMP-Intelligence sub-group from 2010 to 2014. Barbara is currently the co-lead of the Rx-360 Data Integrity Working Group.
Before Amgen, Barbara worked for the consulting firm Don Hill and Associates, providing regulatory and quality services to the pharmaceutical industry, and for Eli Lilly and Company in quality and CMC regulatory affairs positions. She began her career in the pharmaceutical / device industry with Hybritech Inc. and received a bachelor's degree in chemistry from the University of Illinois at Urbana-Champaign. You can contact Barbara at email@example.com.