FDA Enforcement Drops Under Trump Administration

FDA Warning Letters to medical product manufacturers fell by 12% in fiscal year (FY) 2017. According to an agency tally, Warning Letters to drug, biologic and medical device makers totaled 211 in FY 2017, 29 fewer than the 240 issued in FY 2016. Device makers saw the largest decrease in such letters — dropping almost 50% from 81 issued in FY 2016 to 41 in FY 2017. Drug Warning Letters increased marginally from 156 issued in 2016 to 164 in 2017. And biologic letters doubled from three issued in 2016 to six in 2017. Foreign enforcement actions fell from 159 in 2016 to 144 in 2017.

FDA’s enforcement numbers also show that domestic and foreign inspections for medical product makers dropped 13% last fiscal year — 6,943 inspections in FY 2017 compared with 8,013 in FY 2016. Drug inspections saw a 30% drop from 2,878 to 2,016 last year. Device inspections fell 9% from 3,259 in 2016 to 2,958 in 2017. And biologic inspections actually rose 5% from 1,876 in 2016 to 1,969 in 2017.