Concern for drug shortages grows as COVID-19 outbreak drags on
Some drugmakers in China restarted production this week after an extended break for the Chinese New Year, but as the COVID-19 outbreak drags on, governments are trying to get a handle on whether it will result in drug shortages and whether there is anything they can do about it if it does.
China, as the largest producer of active pharmaceutical ingredients (APIs) in the world, is the starting point in the global supply chain for many products.
China’s WuXi Biologics announced this week it has restarted production at three sites. AstraZeneca CEO Pascal Soriot in a call with media said production at its two sites has resumed and they were nearly up to full speed, Bloomberg reports.
“So far, we’ve had relatively limited disruption to our activities,” Soriot said. “We’ll get past this epidemic and China will remain a very important part of our company.”
But in an emergency meeting in Brussels, concerns about shortages were raised by health ministers from France and Finland, CTGN reports. EU Health Commissioner Stella Kyriakides said her group has a task force monitoring supplies, and, for now, no shortages are in evidence.
The FDA late Friday said it is being vigilant and added resources to monitoring the situation closely because it is "keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S." If shortages arise it said "we will use all available tools to react swiftly and mitigate the impact…"
Historically, the FDA and drugmakers have turned to alternate suppliers to help make up shortfalls, but in this case that may be hard to do. That is because China is considered the largest producer of the ingredients drugmakers everywhere require to make their products. Many of those APIs are for generic drugs, and generic drugs make up nearly 90% of the U.S. drug supply.
In India, which gets two-thirds of its APIs from China, the government determined drugmakers have about two-months supply on hand, the Indian Express reports. That is particularly important to the U.S. since the FDA estimates that India accounts for 40% of the U.S. generics.
The Association for Accessible Medicines, whose members make generic drugs and biosimilars, said in an emailed statement that its members spend considerable time and resources each day planning for contingencies, including supply interruptions.
“An event like the coronavirus outbreak is handled by our members in the same manner as other emergency situations, with an immediate review of their individual supply chains,” the statement says. “Our members then make the adjustments necessary to minimize any disturbances to their supply chain. AAM is working closely with all stakeholders, including the U.S. government, to address the needs of patients in the United States for high-quality, FDA-approved generic and biosimilar medicines.”
Feb 15, 2020
https://www.fiercepharma.com/
