“As the spread of COVID-19 threatens to disrupt pharma supply chains and create drug shortages, the Trump administration is reportedly looking for ways to reduce U.S. dependence on APIs and drugs from China. So, how dependent is the U.S. on China for its drugs? The fact is, the FDA doesn’t know.
Janet Woodcock, FDA’s director of the Center for Drug Evaluation and Research, in congressional testimony in October said while it is clear drug production, particularly of APIs, has moved out of the U.S., the FDA doesn’t know a lot more than that. FDA info show the number of Chinese facilities licensed to produce APIs for U.S. drugs is smaller than in the U.S., 13% versus 28%, but those statistics don’t mean much.
“The FDA doesn’t know whether Chinese facilities are actually producing APIs, how much they are producing, or where the APIs they are producing are being distributed worldwide, including in the United States,” Woodcock reported. “… Similarly, we do not have information that would enable us to assess the resilience of the U.S. manufacturing base, should it be tested by China’s withdrawal from supplying the U.S. market.”