What Happens When the World’s Pharmacy is Under Quarantine?

By Cathalijne Adams
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The Coronavirus is further exposing America’s dependence on China for our medicine.

Perhaps this month’s headlines have kept you up at night with Contagion-like nightmares or made you rethink your cruise vacation plans. But the Coronavirus that first emerged in China’s Hubei province could also potentially lead to some serious (and scary) side effects.

That's because much of the world, including the United States, is largely dependent on China for its pharmaceuticals and over-the-counter drugs, and there are few options for manufacturing beyond China’s borders. Furthermore, what limited oversight there was from U.S. Food and Drug Administration (FDA) officials in China is even more minimal, as the FDA moved to halt inspections in the country.

The United States imports everything from over-the-counter vitamins to cancer medication from China. This isn't by accident; China made dominating the world’s pharmaceutical drug supply one of its critical ‘Made in China 2025’ missions and funneled substantial government funds into the sector.

Rosemary Gibson, a healthcare expert at the Hastings Center and author of China RX: Exposing the Risks of America’s Dependence on China for Medicine, estimates that 80% of the key ingredients in America’s drug supply originates in China or India — with China serving as the sole source for some the world’s most commonly used medicines such as penicillin.

Even more troublingly, CNN Business reports that Indian pharmaceutical companies source 70% of its active pharmaceutical ingredients from China.

Should the factory shutdowns due to the Coronavirus continue, the impacts on the health of America’s most vulnerable citizens could be devastating.  

“If China shut the door on exports of medicines and their key ingredients and raw material, U.S. hospitals and military hospitals and clinics would cease to function within months, if not days,” Gibson said in an interview this past year.

Currently, the FDA is actively monitoring pharmaceutical production in China, but has suspended inspections of manufacturing facilities there, in accordance with the State Department’s travel advisory.

“We are 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.,” the agency stated in a Feb. 14 press release.

In lieu of inspections of pharmaceutical manufacturing facilities in China, of which the agency typically conducts approximately 500 a year, the FDA is relying upon increased record requests and import screening among other measures to ensure that drugs entering the U.S. meet FDA standards.

“While the outbreak is impacting our ability to conduct inspections in China,” the FDA states, “it’s important to underscore that the FDA’s regular risk-based process of surveillance testing of imported products, including those from China, which is based on a number of factors, continues. Fortunately, at this time, we are not seeing the impacts of this outbreak resulting in an increased risk for American consumers from imported products.”

However, the FDA has come under intense scrutiny in the past for failing to identify drugs imported from China that were contaminated and has been slow to remove these drugs.

Between 2007 and 2008, the agency's failure to identify contaminants in the blood-thinning medication Heparin led to the death of 246 people.

In her 2018 book, Gibson revealed that the FDA is chronically understaffed and largely unable to effectively monitor the numerous pharmaceutical manufacturing facilities overseas.  

That the FDA has dramatically reduced its capacity to supervise the production of America’s pharmaceuticals in China is serious cause for concern.

However, the answer to this significant threat to public health is not only to increase FDA inspections of overseas pharmaceutical production facilities, but more importantly to support domestic production.

Just this October, the U.S.-China Economic and Security Review Commission warned of the existential threat to the American public posed by China’s dominance of the global pharmaceutical supply.  

As the coronavirus disruption to the U.S. drug supply demonstrates, America’s near-complete dependence on China for medicine leaves our nation excruciatingly vulnerable.   

Listen to Gibson’s interview on The Manufacturing Report podcast to learn how you can check the origin of your medications and how China’s aiming to dominate the world’s drug supply chain.