The coronavirus outbreak in China reached a milestone last week with the sharpest one-day increase of new cases yet, 14,840 in Hubei province. It’s a sign that things will get worse before they get better. 

As the world watches China grapple with an unprecedented crisis, here at home the alarm is waking up some in Washington to a shocking vulnerability in our nation’s health security. The U.S. depends on China for thousands of chemicals needed to make prescription drugs; in fact, we depend on China for 80 percent of the core components to make our generic medicines. And today, generics represent some 90 percent of all prescriptions dispensed here in the U.S. 

With China on lockdown to prevent the spread of the coronavirus, industrial production to supply America’s pharmacies and medicine cabinets is at risk of interruption. With just-in-time inventories, drug shortages and a lack of availability in the coming months are very real prospects that are keeping many people up at night.   

Medicines to treat the coronavirus depend on Chinese suppliers

Thankfully, the U.S. has been spared so far from a widespread outbreak. But last week the Centers for Disease Control and Prevention (CDC) said it expects the coronavirus to “take a foothold” here. 

If that happens, people who become seriously ill from the coronavirus and require hospitalization will be cared for using many medicines sourced from China. Here are some examples: 

Sedatives such a fentanyl and propofol, which are administered to people placed on ventilators to help them breathe, are made with core ingredients from China. 

Medicines to treat shock, such as epinephrine and dopamine, are also made with chemical components from China. Antibiotics to treat sepsis, a life-threatening bloodstream infection, are make with raw materials supplied by China.  

Shortages of medicines are like hurricanes: both are predictable. Yet whereas we have a response system in place for hurricanes, we neither predict nor have a response system for the very real possibility that our drug supply lines could be severed. And unlike hurricanes, drug shortages are largely preventable. 

The present predicament is the result of our treating generic medicines as cheap commodities rather than strategic assets to sustain human life.  

It hasn’t helped that the outsourcing of our generic medicine manufacturing to China has been a well-kept secret. That’s why it took three years to do the research for my book, China Rx: Exposing the Risks of America’s Dependence on China for Medicine, which first revealed this vulnerability.  

FDA: Rely on China for emergency preparedness 

As hospitals scramble at the last minute for a solution to a potentially very serious situation, the FDA has proposed that drug manufacturers prepare risk management plans that spotlight choke points in supply chains. The agency would also require companies to identify alternative sources if a major disruption occurs. But there’s a big problem with these proposals: they depend on Chinese companies to help us when we are facing a crisis.   

Consider that China’s domestic businesses are making many of the generic drugs prescribed by doctors and taken by millions of Americans. I predict they will capture 20 percent of the U.S. market share by 2025. And by the 100th anniversary of the founding of the People’s Republic of China, Chinese domestic companies will supply at least 80 percent of America’s medicines.   

With these projections, let’s go back to the FDA’s proposal. It would require Chinese manufacturers to tell the agency about their alternative sources in the event of a major disruption. In effect, the FDA’s plan is for the U.S. government to rely on China to help us be prepared for emergencies. Remarkable indeed.   

In addition to supply problems, the quality of generics made in China is a big issue. The FDA is already highly constrained when it conducts inspections of drug manufacturing facilities there. Now the agency has recalled its inspectors from China because of the coronavirus, and it will be many months before they return. The FDA cannot require employees to go to China; these assignments are voluntary. And it’s unlikely that anyone will want to travel there for the foreseeable future.  

Imagine you are an FDA employee inspecting a manufacturing facility in China and you observe serious violations of U.S. standards. You write a report and submit it to the agency. The FDA has the authority to stop the company from exporting medicines to the United States. Would the Chinese government, and the company you inspected, want you to conduct any more inspections? Would you want to go back, fearing possible retaliation?   

A strategic choice

We have a strategic choice to make as a country. We can continue down the current path, increase our dependence on China, and accept the risk to our survival that this entails. 

Or we can invest in domestic manufacturing of a minimum level of production of essential medicines to prevent a situation where our supply is severed. 

Some say the market should decide and government should not be involved. But bear in mind that U.S. companies aren’t competing with Chinese companies. They are competing with the Chinese government, which subsidizes its industry. This is hardly a free market.   

The coronavirus outbreak in China is showing the world that the unthinkable can happen. Next time, it could be New York, Chicago, Los Angeles, or Washington, D.C. We need a plan to predict, prepare, and respond, to ensure a sustainable supply of trustworthy medicines and medical supplies, including masks, gloves, and gowns, to protect doctors, nurses, and the public. And we need to execute the plan. But first, Washington policymakers in Congress and the executive branch need to make a decision. The public awaits their answer.   

Rosemary Gibson is senior advisor at the Hastings Center and author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine. Follow her on Twitter @Rosemary100.