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.”
The White House is working on an executive order to close “loopholes allowing the government to purchase pharmaceuticals, face masks, ventilators and other medical products from foreign countries,” sources have told The New York Times. The hope is that raising federal demand could nudge drugmakers to move production to the U.S. But this comes as falling U.S. prices for generics among growing world production has led many drugmakers, some with plants already in the U.S., to sell off or close facilities making generics as they concentrate on high-margin, specialty drugs .
Novartis is expected within the month to close a deal with India’s Aurobindo for about 300 generics drugs that it no longer felt were worth keeping, along with three U.S. manufacturing facilities. GlaxoSmithKline just agreed to sell a drug manufacturing facility in Canada to a Taiwanese CDMO as the U.K. company focuses on other areas.
The FDA has suggested that “advanced manufacturing technologies” could help U.S.-based drug production make up ground against China and other countries. Processes like continuous manufacturing and 3D printing facilities are cheaper to build and operate, but they also are a major departure from more than 100 years of batch production. While the agency can’t force drugmakers to make those moves, “incentives” might lead them to it, Woodcock suggested.
There's a small number of drugmakers already going this direction. Pfizer has developed what it calls Portable Continuous Miniature Manufacturing, modular plants that can fit on a truck. Through continuous manufacturing, they can reduce the time needed to get products to market from years to days. It is using the process for both API and large-molecule drug production across its manufacturing network, including in the U.S.
Pfizer has three API facilities in the U.S. in Kalamazoo, Michigan; Franklin, Ohio; and Middleton, Wisconsin. Pfizer spokeswoman Kimberly Becker says “less than 2% of our active pharmaceutical ingredients (API) and key materials globally are sourced from China.”
Whether the novel coronavirus will be the tipping point for drugmakers to adopt new technologies is still unknown, but, Woodcock told Congress, “These new ways of making drugs could, with the proper strategies, revitalize pharmaceutical manufacturing in the United States.”