Dr. Stephen Hahn of the U.S. Food and Drug Administration reports the agency is closely monitoring the supply chain with the expectation that the COVID-19 outbreak will impact the medical product supply chain. And this implies a high probability of disruptions to supply or critical product shortages in America. These potential shortages include an actual drug needed for this crisis. The FDA pays particularly close attention to the Chinese element of the U.S. supply chain given that country was the epicenter and the level and extent of outsourcing of medical products and supplies to that country.
The FDA has contacted over 180 drug manufacturers reminding them of their legal requirements of notice to the FDA should they anticipate any disruption. Additionally, they have requested that these drug makers evaluate, holistically, their supply chains, such as active pharmaceutical ingredients not to mention other components produced in China. Along these lines the FDA identified about 20 other drug products which sole source active pharmaceutical ingredients to China. Thus far, the firms don’t report shortages due to the COVID-19 outbreak, reports the FDA in a press release. The FDA will continue to monitor and alert the American public.
The FDA reports 63 manufacturers representing 72 facilities in China that produce essential medical devices. These are products that could be subject to shortages in the case of COVID-19 supply disruptions. The FDA has contacted all of them and thus far no supply disruptions are reported. However, the FDA reports several firms in China do report challenges including the quarantine of workers.
TrialSite News has reported on localized instances where emergency room physicians and clinical investigators shared that there were in fact significant shortages for key protective gear such as masks, etc. According to the FDA press release, they too have heard of such instances. However, the agency is not aware of specific widespread shortages of medical devices or protective gear, but they do note that the CDC and other U.S. partners have informed of significant sales demand for a range of human medical products and ancillary protective gear as some U.S. healthcare facilities prepare for greater demand as the outbreak intensifies.
The concern here is that although the FDA does acknowledge that they have heard of challenges in the supply chain they report that there are no “widespread shortages.” Well, in a way that doesn’t matter. There is certainly a localized crisis of supply, such as ones discussed yesterday. These localized supply crises pose danger to medical professionals and patients. They are certainly an example of a less than optimal medical protective gear and equipment supply chain.
Medical Device Makers not under Legal Obligations
The FDA reports that medical device manufacturers are not under any legal obligation to notify the FDA of potential shortages or even if a product will be discontinued that could eventually lead to a shortage. Moreover, they are not legally obligated to respond to the FDA requests for information about supply chain disruption. But the FDA has taken proactive measures to be in touch with these device makers.
Biologics and Blood Supply
Additionally, the FDA reports that at this time there are no known cellular or gene therapies made in China for the U.S. market. And there are no reported shortages at this time. The agency reports no shortages of biologics.
Generally, respiratory viruses are not known to be transmitted by blood transfusion. But the FDA doesn’t know what the potential for the potential of transmission of COVID-19 by blood and blood components are at this time.Source: U.S. Food and Drug Administration