China has become the world’s largest producer and exporter of “active pharmaceutical ingredients,” the base components drug companies use to manufacture most of the medications we rely on. China’s dominance puts both the health of Americans and our national security at risk.
According to the findings of a new report from the U.S.-China Economic Security Review Commission, which was established by Congress in 2000, China’s pharmaceutical industry “is not effectively regulated by the Chinese government” and has been responsible for a number of drug safety scandals.
Our dependence on Chinese pharmaceutical products, the commission concluded, means “the American public, including its armed forces, are at risk of exposure to contaminated and dangerous medicines.”
The risk comes not only from the possibility of poorly overseen manufacturing, but also because of possible interruptions in production or a trade war. “Should Beijing opt to use U.S. dependence on China as an economic weapon and cut supplies of critical drugs,” the report noted, “it would have a serious effect on the health of U.S. consumers.”
The Chinese government promotes and protects the nation’s pharmaceutical companies to the disadvantage of foreign competitors, as it does in other sectors; yet because of our dependence on the drug components China produces, we have little leverage.
The situation is a prescription for disaster, and U.S. consumers, as well as many government officials, are woefully ignorant of the situation. People often have no idea the medications they rely on are made from Chinese components, since manufacturers only have to say where a finished drug was produced.
If China were to block or slow supplies of ingredients needed for common, essential drugs, like those to treat hypertension, stroke, cardiac disease, infections, diabetes and other serious conditions, morbidity and mortality would skyrocket worldwide. In effect, we could see a policy-induced pandemic.
Even in the absence of such actions by China, supplies of key drugs are sometimes uneven. As of Dec. 4, the FDA was reporting shortages of 116 different drugs, including key chemotherapy drugs and other medications used to treat serious disease. As a result of drug shortages, U.S. hospitals and medical personnel sometimes have had to resort to second- or third-line medicines.
So what can we do to address the dangers?
First, Congress needs to take stock of the situation. We need to know exactly how dependent the United States is on Chinese pharmaceuticals and precursors. We need to know what other sources are available, including domestically, and how close those sources might come to meeting our needs.
We also need to understand exactly what the FDA can and can’t do to guarantee the safety of precursor imports from China. The FDA deploys some inspectors there, but there are far too few to monitor the large number of producers. Once Congress understands the situation, it should take steps to grant whatever new authority is necessary to the FDA and other agencies to better protect the quality and quantity of medicines necessary for the health of Americans. And it should without delay direct the FDA to increase the number of inspectors in China.
Another step Congress could take is requiring drug manufacturers to fully disclose to consumers where the active pharmaceutical ingredients used in a drug come from. It isn’t enough to disclose where the final drug was made.
Congress could also use its considerable power of the purse to protect Americans by requiring government health systems (including Medicare, Medicaid, the U.S. Department of Veterans Affairs) to buy pharmaceuticals only from domestic manufacturers or production facilities abroad that can be inspected and certified by the FDA.
In recent decades, we have seen increasing globalization of pharmaceutical production. This is a good thing, with the potential to ensure adequate supplies of vital medicines. But the whole system is compromised when it relies too heavily on a single, potentially unreliable source of ingredients.
Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was founding director of the Food and Drug Administration’s Office of Biotechnology. John J. Cohrssen is an attorney who has served as counsel for the House Energy and Commerce Committee.