FDA enforcement metrics for FY2014 were published on April 17, 2015. This practice began with the publication of FY2009 data. The metrics provides a high level overview of the number of enforcement actions including: injunctions, seizures, warning letters and recalls conducted by all FDA Centers. This posting will look at the data from the enforcement metrics in two ways:
- First, we will address the data presented in the FY2014 slide deck. These data represent all centers of the FDA: Center for Drug Evaluation and Research (CDER), Center for Biologic Evaluation and Research (CBER), Center for Devices and Radiologic Health (CDRH), Center for Veterinary medicine (CVM), Center for Food Safety and Nutrition (CFSAN) and Center for Tobacco Products (CTP).
- Second, we’ve developed additional graphs from data in FDA enforcement metrics published between 2009 through 2014 that address only CDRH (devices) and CDER (drugs). We look at trends over the entire time period for a selected set of actions. Data from CBER, CFSAN, CVM and CTP are not included. CBER is not included because the majority of enforcement actions are taken against blood and plasma entities. The figures in this section are not published in the FDA metrics.
The data provided in these metrics includes numbers of events but do not identify the firm(s) involved. For example, companies associated with products seizures or injunctions are not identified. Nonetheless, the information is useful to provide a high level year over year perspective on FDA’s enforcement actions.
- CONCLUSIONS based on FDA FY2014 Enforcement Metrics: Each conclusion references the slide number(s) in the FDA deck. Considering only the data in the 12 slides in this year’s deck:
- Seizures continue to decline from a high of fifteen in 2011 to four in 2014. CDER and CFSAN each initiated two product seizures in 2014. (slides 2 and 3)
- Injunctions also decreased from the upper teens between 2010 and 2013 to ten in 2014. CFSAN was associated with 8 injunctions and CDER and CVM were associated with one injunction each in 2014. (slides 4 and 5)
- Total warning letters continues to increase dramatically. FDA issued a total of 8,690 warning letters in 2014 and 8,220 of them were issued by the Center for Tobacco Products. All other centers combined issued a total of 470 warning letters. CTP accounts for 95% of the warning letters issued by FDA in 2014. (slides 6 and 7)
- The total number of recalled products from all Centers is essentially unchanged at 8061 from 2013 (8044), and almost the same as in 2009 (8065). The number of products recalled in the years 2010 – 2012 ranged between 9288 and 9469. In 2014, CDRH had the most products recalled (2706) followed closely by CFSAN (2549), then CDER (1647), CBER (992), CVM (167) and no recalls of tobacco products. The number of recall events was markedly lower than the number of recalled products in all cases. (slides 8 – 11)
- CFSAN lead the number of Class I recalls for both events (221) and products (1117). CDRH followed, then CDER, CVM, CBER and again the center for tobacco products had no recalls. (slide 12)
- CONCLUSIONS based on FDA data from 2009 – 2014 for CDER and CDRH.
As mentioned in the Background section, data used to construct the Figures supporting the conclusions below are taken directly from the FDA slide decks of enforcement actions from 2009 through 2014. The figures do not, however, appear in the FDA slide decks. The conclusions in the bullet points identify the associated figure which readers should reference
- The combined number of injunctions associated with CDER and CDRH increased between 2009 and 2013, but decreased in 2014. The numbers for both injunctions and seizures are small and variations in absolute numbers may not be meaningful. The drop in the number of injunctions between 2013 and 2014 does appear significant, but in all cases the numbers are small. 2014 saw the fewest number of injunctions in the past 6 years. (Figure 1)
- The combined number of product seizures associate with CDER and CDRH decreased between 2010 and 2013 but increased slightly in 2014. In both cases, the number of seizures and number of injunctions, the numbers are small and don’t readily allow identification of trends. (Figure 1)
- Warning letters issued by CDRH increased between 2010 thru 2013 (with a dip in 2011), followed by a dramatic decrease in FY2014. Warning letters issued by CDER have markedly decreased from their peak in 2010 yet increased slightly this year to the same level as in FY2012. Please note theses are not exclusively GMP warning letters but include ALL warning letters issued by the specific Center. (Figure 2). For additional analysis of GMP warning letters, please see a previous blog entry.
- Total CDER recalls events and products show no discernable trend over the period 2009 – 2014. The number of recalled products continues to outnumber the number of recall events. (Figure 3)
- The number of Class I CDER recall events has gradually increased from 2009 through 2014. The number of products subject to a Class I recall in each year reached a high point in 2010, decreased in each of the next two years and then increased so that the number for 2014 is essentially the same as in 2010. I have not evaluated the numbers, but it may be that the recalls of multiple products from several compounding pharmacies / outsourcing facilities in 2014 was the cause of the dramatic increase in the number of recalled products. We may take a look at this in a future blog entry. We will be addressing recalls of parenterals due to foreign particles sometime in early July that will cover 2011 thru mid-2015. (Figure 4)
- Total CDRH recall events have remained reasonably consistent from 2011 through 2014. The number of CDRH recalled products increased from 2009 through 2011, then decreased until 2013 only to increase again in 2014. (Figure 5)
- The number of Class I CDRH recall events has increased gradually. The number of Class I products subject to recalls increased from 2009 through 2011, decreased significantly in 2012 and has continued to increase through 2014. (figure 6)
- The question often arises as to whether Class I recalls as a percentage of total recalls is increasing over time. When considering only CDER Class I recall events as a percentage of the total CDER recall events, values from 2009 through 2013 varied between 9% and 14%. In 2014, the value increased significantly to 21%. This may be due to the recalls conducted by some compounding pharmacies where sterility of product cannot be assured. We will follow this when data publish next year, or in a future blog post. The number of products recalled also increased but did not approach the previous high in 2010. (Figure 7)
- The question often arises as to whether Class I recalls as a percentage of total recalls is increasing over time. When considering only CDRH Class I recall events as a percentage of the total of CDRH recall events, values remain consistent between 4% and 6%. For CDRH Class I recall products as a percentage of total CDRH recalled products, the values between 2012 and 2014 clearly show an increasing trend. The value in 2014 however, is essentially the same as in 2010 and 2011. This may simply represent normal variability given small numbers but it is something we will monitor in the future. (Figure 8)
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