America’s Drug Supply Depends on India and China. You Should Fix That, FDA.
Every year, millions of Americans depend on drugs like carboplatin, a common cancer drug, and antibiotics to save their life, but that doesn’t mean they’re readily available. America’s drug shortage problem, which has been festering for decades, has become a serious issue impacting most U.S. hospitals and their patients.
As is often the case in the health care industry, there is a complex reason but relatively simple solution for drug shortages. That fix was highlighted on Tuesday in a letter from 11 governors to Congress calling for, among other policy changes, diversifying the U.S.’s drug supply. (READ MORE: China’s 21st Century Empire Building)
The letter’s signatories, which included Kristi Noem (S.D.), Sarah Sanders (Ark.), Eric Holcomb (Ind.), Kim Reynolds (Iowa), Tate Reeves (Miss.), Mike Parson (Mo.), Greg Gianforte (Mont.), Joe Lombardo (Nev.), Chris Sununu (N.H.), Greg Abbott (Texas), and Mark Gordon (Wyo.), noted that the drug shortages currently plaguing U.S. hospitals are “not new, but they are becoming more frequent and more severe.” The governors expressed frustration that there hasn’t been a “good explanation for why.”
Their complaint may be a little tongue-in-cheek. The letter pointed out that more than 80 percent of active pharmaceutical ingredients (APIs) found in American prescription drugs come from China and India. “This limited supply chain creates a national security risk,” they wrote, “and leaves America competing with other nations for essential resources.” The governors are concerned that “the Chinese Communist Party has gained far too great of an influence over our prescription drug manufacturing.”
Most American Drugs Depend on China and India
Back in 2019, the Council on Foreign Relations noted in its analysis of the ongoing shortage:
We certainly underestimate the share of APIs from China given that Chinese-made APIs can come to the United States as part of the finished drug products from countries like India. However, the lack of a reliable API registry makes it difficult to estimate the true market share of Chinese-made APIs.
Unfortunately, sourcing APIs from China is not without risk; not only could our dependence on the CCP backfire if it decides to use that dependence as a weapon against us, but Chinese-made drugs — like most things made in China — are not known for their high quality or safety.
Let’s imagine a (not unlikely) scenario in which China invades Taiwan, and the U.S. chooses to defend it. The fact that we depend on China for treating cancer, bacterial infections like RSV, and other life-threatening conditions means that the war will be waged not just on a small island off the coast of China but also in the hospital rooms of millions of American cancer patients. (And, of course, a hypothetical invasion of Taiwan wouldn’t be good news for Chinese cancer patients either.)
China’s drug supply is also frequently subpar. As the Council on Foreign Relations wrote:
In the summer of 2018, one of China’s largest domestic vaccine makers sold at least 250,000 substandard doses of vaccine for diphtheria, tetanus, and whooping cough. It was the latest in a slew of scandals caused by poor quality drug products made in China over the last decade.
China isn’t the only country we depend on for our pharmaceutical drug supply — we have also become increasingly reliant on India, which sources many of its APIs from China. Even disregarding that inconvenient fact, the quality of drugs from India is even worse than those from China. (READ MORE from Aubrey Gulick: AI Could Become Medicine’s Right-Hand Man)
One of the contributing factors to the current chemotherapy shortage is the “almost farcical conditions” discovered by FDA inspectors last November when they investigated an Indian manufacturing plant owned by Intas Pharmaceuticals. According to the Atlantic:
The plant … had hardly any working systems for ensuring the purity or sterility of its products. And its employees were trying to conceal evidence of these problems by shredding and hiding documents or, as one quality-control officer admitted, dousing them in acid.
Intas Pharmaceuticals is a major supplier of cancer drugs, providing “half of the country’s supply in some cases.” The fact that it has been forced — rightly — to cease production has left hospitals on this side of the globe scrambling to figure out how to treat patients without the drugs they need.
Americans Should Make American Drugs
The solution, as the governors’ letter earlier this week indicated, is fairly simple in its concept. America needs more American drug manufacturers sourcing products from the United States. And the governors aren’t the only ones calling for it.
In July, the American Hospital Association told Congress that “diversifying manufacturing sites as well as sources of critical raw materials to ensure supply chain sustainability” is crucial to the effort to pull the U.S. out of the drug shortage crisis. (READ MORE: Weight-Loss ‘Miracle Drugs’ Under Fire for Potentially Causing Cancer They May Prevent)
That same month, the Hill reported that the FDA is planning on doing the exact opposite. The government agency announced that, in order to address the cancer drug shortage, it would, according to the Hill, be “opening the way for more cancer drugs from China as the U.S. continues to deal with an ongoing shortage in key chemotherapy treatments.”
Addressing a festering issue requires a long-term solution. In some ways, the current drug shortage crisis could be the golden chance the U.S. needs to shore up and expand American manufacturing of pharmaceutical drugs — after all, China and India certainly seem to be incapable of meeting U.S. demand. Given the national security risks and fickle supply chains, common sense dictates that Americans turn to Americans to produce life-saving medications. Unfortunately, there’s not a lot of common sense around.
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