A physician who reads this blog sends along this summary of the Government Accounting Office’s report in December warning of the vulnerability of US drug supply lines. From the GAO report:

More than 60 percent of establishments manufacturing drugs for the U.S. market were located overseas in fiscal year 2018. FDA has estimated that about 40 percent of finished drugs and 80 percent of active drug ingredients are manufactured overseas. FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States, regardless of where they are produced and conducts inspections of both foreign and domestic drug manufacturing establishments. GAO has had long-standing concerns about FDA’s ability to oversee the increasingly global supply chain, an issue highlighted in GAO’s High Risk Series for the last 10 years. GAO recommended in 2008 (GAO-08-970) that FDA increase the number of inspections of foreign drug establishments. GAO found in 2010 (GAO-10-961) and 2016 (GAO-17-143) that FDA was conducting more of these foreign drug inspections, but GAO also reported that FDA may have never inspected many establishments manufacturing drugs for the U.S. market.

The GAO’s concern is about drug quality, but notice the part I highlighted above. Most drugs are made overseas. In this map from that GAO report, we see that over 400 such facilities are in China:

WIRED reports:

The biggest problem is that there is no publicly available information on what portion of which critical medicines originate in China, and specifically where those factories are located, she says. Pharmaceutical companies consider such information to be proprietary. “One of the big unknowns is how many products are sole-sourced—in which literally only one place in the world makes that raw material,” she says. “We don’t have good information on that at all.”

China has 15 percent of the world’s facilities that manufacture active pharmaceutical ingredients for 370 essential drugs, while the US has 21 percent of those facilities, according to the FDA. But the agency doesn’t know how much those facilities produce—if they produce anything at all.

That lack of information is unsettling. “What is the threat to our national health care if there is some kind of geopolitical issue or an outbreak like this or some kind of natural disaster? We really don’t know,” says Michael Ganio, director of pharmacy practice and quality at the American Society of Health-System Pharmacists.

More:

“All it takes is one plant to shut down to cause a global shortage. That’s because there’s such concentration of global production in China,” says Rosemary Gibson, author of China Rx and a strong advocate for rebuilding domestic capabilities.

“This is a warning to the United States and other countries,” she adds. “If you have a supply chain concentrated in a single country, no matter what country it is, that’s a risk of epic proportions.”

Congress should prepare legislation now to address this problem. It’s too late for the coronavirus crisis, but maybe not for future crises.