Pharma Supply Chain

As we have noted multiple times before the reliance on China as a key element in our pharma supply chain is an exceptionally high risk factor. As JAMA has just noted:

As the US and other countries have increasingly become dependent on procuring the ingredients for many pharmaceutical agents from India or China, oversight by the US Food and Drug Administration (FDA) of non-US manufacturers has not kept pace. In 2018, the FDA conducted onsite inspections of only about 20% (935) of the estimated more than 4000 registered non–US human drug manufacturing facilities abroad, and language barriers, travel constraints, and bureaucratic issues have created challenges with completing the inspections. In congressional testimony in 2019, the FDA has cited inspector vacancies, lengthy training requirements, and restrictive foreign facility policies as impediments to a more rapid ramp-up of its overseas inspections.⁷ The FDA has issued multiple recalls of suspected contaminated drugs in recent years, including the widely reported alert involving much of the generic drug valsartan, which was found to contain the carcinogenic contaminant, N-nitrosodimethylamine. In 2008, a recall of contaminated heparin containing components traced to unregulated Chinese family pig farms was associated with 81 deaths in the US. Both the valsartan and heparin recalls involved contamination from Chinese factories that lacked adequate inspections by US regulators.

 Hopefully the current viral outbreak will open the eyes of regulators and lawmakers to the irreparable harm that could result if we allow this to continue!