The existential threat that China has become to the United States is well documented in recent national security strategic documents. China’s occupation of the disputed Spratly Islands in the South China Sea, their research and development of hypersonic weapons, and modernization of their military all clearly demonstrate the growing menace to America’s way of life. Less articulated, but no less important a threat to national security — especially given the current trade war with China — is China’s production of poor quality and tainted drugs.
China has become the world’s largest supplier of active pharmaceutical ingredients, or API, providing key components to drugmakers worldwide. “The national security risks of increased Chinese dominance of the global API market cannot be overstated,” Christopher Priest, the acting deputy assistant director for health care operations and Tricare for the Defense Health Agency, recently told the U.S.-China Economic and Security Review Commission. The Defense Health Agency manages the health care of military members, including prescription drugs. Concerns about the safety and quality of Chinese-made drugs are rising at a time of heightened trade tensions between Washington and Beijing.
A recent Bloomberg report found that “the Trump administration sees the increasing use of Chinese-made active ingredients in drugs taken by U.S. troops and civilians as a national security risk.” The FDA has issued multiple recalls of generic valsartan, a blood pressure drug, due to the presence of a cancer-causing chemical called NDMA — a product used to make rocket fuel. According to the New York Times, “the tainted valsartan came from a Chinese manufacturer, Zhejiang Huahai Pharmaceutical Company,” and was distributed in the U.S. by generic giant Teva Pharmaceutical Industries, among other companies.
The tainted Chinese valsartan was purchased by the Defense Logistics Agency, which oversees the supply chain for U.S. military health care facilities. The Bloomberg report quotes Larry Wortzel, a member of the U.S.-China Economic and Security Review Commission: “[My blood-pressure medications] were contaminated with rocket fuel. I imagine active people have the same problem. This affects the readiness of our troops.”
Lax regulation in foreign countries put the safety of patients at risk as well. Though the number of generic drugs approved by the FDA increased 94 percent since fiscal year 2014, the number of surveillance inspections done globally — to ensure drug-making plants meet U.S. standards — dropped 11 percent in fiscal 2018. Margaret Hamburg, the FDA commissioner during the Obama administration, sees this decline as a cause of concern to the integrity of the products noting: “Maintaining, if not increasing, inspections would seem crucial, given the global sourcing, supply chain, increase in approvals and quality issues.”
Issues with data integrity at companies in China are causing doctors to question whether or not the drugs are working the way they’re intended, as the FDA typically counts on the drug manufacturers to identify and report problems through company testing. The FDA has increasingly issued warning letters to production plants in India and China, with both countries receiving 39 of 61 notices sent by the Office of Manufacturing Quality in the FDA’s Center for Drug Evaluation and Research in 2017.
According to the FDA, about 80 percent of the manufacturers of active ingredients used to make US-consumed drugs are located outside of the country. Given concerns around the decrease in FDA surveillance inspections of foreign and domestic drug manufacturing facilities, the House Energy and Commerce Committee has written to the FDA Commissioner for a briefing on the FDA’s efforts to preserve the integrity of patients’ drugs.
The good news is that the National Security Council is examining the practice of sourcing medicines from China, and some experts are calling for a stricter examination of the military’s sourcing of prescription drugs. Rosemary Gibson, in testimony to the U.S.-China commission, said: “We wouldn’t have our aircraft carriers and nuclear submarines built in China, and for very important medications we really should look at what it takes to purchase based on value not just price. We want cheap, we can buy cheap. But what’s missing from the whole equation is quality.”
The bottom line is that a reliance on foreign medicines from potentially hostile powers leaves us susceptible to shortages if China were to cut off drug shipments to drive leverage in other foreign policy negotiations. Unsafe Chinese generics don’t just threaten national security by potentially delivering poisonous medicines to our troops, but also threatens the health and wellness of the whole population.
NOTE: An earlier version of this story referenced Scott Gottlieb, who stepped down as FDA commissioner in April.
Gregory T. Kiley is a former senior professional staff member of the Senate Armed Services Committee and U.S. Air Force Officer.