Amid rising concern over the quality of the pharmaceutical supply chain, a government report finds that the number of domestic and foreign plant inspections conducted by the Food and Drug Administration declined from 2016 through 2018, partly due to a dearth of available inspectors.
Specifically, domestic inspections decreased by 13% and foreign inspections fell by 13% during that two-year period, although the number of foreign inspections exceeded domestic inspections in 2015. But while the FDA had 190 inspectors in the U.S. who conducted most foreign inspections, another 58 positions were vacant, according to a preliminary analysis by the U.S. Government Accountability Office.
This GAO report regurgitates the same data about what percentage of our “American” drugs are foreign made. It states: “FDA has estimated that about 40 percent of finished drugs and 80 percent of active drug ingredients are
manufactured overseas.” According to our research from last year, 71 of 100 top brand name drugs, as in finished drugs, were foreign made: https://www.pharmacychecker.com/news/fdas-drug-importation-data-is-wrong/.
As we consider importation, getting our facts straight about what percent of our drug supply is already imported should be a priority.
Janet was specifically asked (twice) about using external contractors to supplement the foreign inspection staff. Both times she declined to even directly address the question. For some reason, even though the FDA is struggling to hire inspectors, retain inspectors, and train inspectors, there is no plan to use outside contractors to conduct inspections. It boggles the mind.
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