Struggles with Test Kit Shortages Hinder U.S. Efforts to Mount a Response
Here in the U.S., (as of Mar. 16, 2020) cases have climbed to over 3000 in 49 different states and Washington, D.C. with at least 67 deaths so far. In early February as coronavirus cases started to rise in the U.S., the Centers for Disease Control and Prevention (CDC) announced they had shipped 200 kits that could test up to around 160,000 samples from patients to labs around the country. That initial round of expanded testing proved to be problematic because it was found that some of these kits were faulty.
Now the country faces a shortage of tests because of manufacturing struggles to meet the demand for millions of tests as Americans discover they might have unwittingly spread the disease to dozens of other people. A priest in Washington, D.C. was quarantined after testing positive, but not before he had shaken hands and distributed communion to possibly hundreds of members of his congregation, prompting the CDC to ask that the entire church self-quarantine. As instances like this continue to happen, the increasing demand for tests will further exacerbate the growing deep backlog faced by test kit manufacturers.
Fears over the spread of the virus have disrupted travel for business, conventions and tourism around the world, spooked the stock market and prompted schools and university campuses to switch entirely to online learning to avoid inadvertent transmission.
However, disruption to daily life might not be the only concern for Americans.
A Precarious Supply Chain
In a report in February, the FDA stated they were limiting or postponing inspections on drug and medical device manufacturers out of safety for its officials, further slowing down the timeline for product entry to U.S. markets at a time when demand is increasing to manage the spread of the disease.
While pharmaceutical and medical device manufacturing companies are required by law to warn the U.S. government of any potential shortages or other disruptions to their supply chains, the FDA has taken the extra step of reaching out to companies to remind them of these obligations.
The crisis over the coronavirus has brought renewed attention to major flaws within the medical supply chain for the U.S., primarily revolving around dependence on Chinese products.
According to the FDA, around 13.4% of all drugs imported to the U.S. come from China, with about 83% of that being completed products, 7.5% being active pharmaceutical ingredients (APIs) and the rest being drugs for animals.
APIs are the crucial core components of drugs that pharmaceutical companies use to build their products. China is one of the most dominant producers of APIs, accounting for as much as 40% of the world’s supply of APIs. That fraction keeps growing, leading to increased reliance on Chinese production worldwide. India, for example, uses as many as 80% Chinese APIs to manufacture its generic drugs, many of which are also imported to U.S. markets.
On Feb. 27, 2020, the FDA issued a statement saying that an undisclosed pharmaceutical company could no longer produce an undisclosed drug because it lost access to the critical active pharmaceutical ingredient (API) needed to make the drug. They did note that for the time being, there were plenty of alternatives still available on the market, but the situation requires close monitoring as the virus continues to affect the markets and supply chain.