The agency’s annual enforcement report signals mixed enforcement trends for pharmaceutical companies and medical device makers. While the pharmaceutical sector appears to be increasingly in the crosshairs of warning letters, recalls have fallen. On the flip side, medical device makers are seeing a notable decline in warning letters but an uptick in recalls.
The FDA’s annual enforcement statistics show that in FY2016, the Center for Devices and Radiological Health (CDRH) issued only 85 warning letters – a notable decline from the 168 it issued in 2015. In parallel, the Center for Drug Evaluation and Research (CDER) issued notably more letters in 2016 (151) compared with 2015 (76). Enforcement levels at the Center for Biologics Evaluation and Research (CBER) remained flat, with only four letters issued in 2016. Overall, the agency experienced a substantial decline in warning letters in 2016, dropping from a peak of 17,232 in 2015 to 14,590 in 2016. With the exception of the Center for Tobacco Products, which is responsible for the majority of letters, CDER lagged only behind the Center for Food Safety and Applied Nutrition (CFSAN) in the number of warning letters.
The agency experienced an overall decline in recalls, though levels remained above lows observed in 2013 and 2014. As is typically the case, the CDRH continued to lead the pack in terms of recall events – issuing slightly more in FY2016 (1,183) than in 2015 (1,175). The CDER experienced a decline in recalls from 303 in 2015 to 277, as did the CBER, which saw recalls decline from 651 to 575.
Notably fewer recalls by the CDRH were classified as Class I in 2016 (111) than 2015 (287). However, this drop was accompanied by a jump in the number of Class II (2,671 v. 2,484) and Class III (116 v. 69) recalls. Recalls by the CDER were primarily deemed Class II (1,272), though there was an uptick in the number of Class III recalls (170 vs. 120). Recalls by the CBER were mostly categorized as Class II (513) and Class III (267), with only one deemed Class I. Indeed, CBER lagged only behind the CFSAN in terms of Class III recalls.
Despite the decline in warning letters and recalls, the FDA actually experienced a slight increase in the number of seizures – up from one CDER seizure in 2015 to a total of four, one of which was by the CDRH and one of which was by CDER. Irrespective of the slight climb, however, seizure levels remained low compared with the high observed in 2011 (15). In terms of injunctions, there was a slight decline (17 vs. 21), primarily due to a drop in CDRH injunctions (from four in 2015 to none in 2016).