As COVID-19 spreads worldwide, U.S. legislators and health officials worry about the impact the disease will have on Americans' access to pharmaceuticals and medical equipment made overseas, especially in China.
Experts say U.S. dependence on foreign-made products, including medicine, puts the nation’s health security at risk. Both of Missouri's U.S. senators, Roy Blunt and Josh Hawley, have bills that would address what Blunt characterized as a danger.
The U.S. Food and Drug Administration reports that nearly 40% of finished drugs and roughly 80% of active pharmaceutical ingredients are manufactured in more than 150 countries overseas — primarily China and India.
Global disruptions tied to COVID-19, the illness caused by the new coronavirus, have sparked concerns that shuttered plants in China and elsewhere will cause shortages in the United States.
On Feb. 27, the FDA said it had been alerted by a U.S. drug manufacturer of a shortage of a drug stemming from a site affected by COVID-19. It did not release the name of the company, or the drug.
In a statement, the agency said: "The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug. It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage."
Drug manufacturers are required to notify the FDA of supply disruptions.
China ranks second among countries that send medicines to the U.S., according to the FDA; it is also the top exporter of medical devices and equipment to the U.S.
For decades, the pharmaceutical industry has shifted manufacturing to China, India and other countries to take advantage of cheaper labor and materials. Even medicines made in other nations, such as India, rely on Chinese drug ingredients to make finished generic pills.
Last summer, Rosemary Gibson, senior adviser at the Hastings Center and author of “China Rx: Exposing the Risks of America’s Dependence on China for Medicine," testified before the U.S.-China Economic and Security Review Commission on the threat posed by the growing U.S. dependence on China for biotech and pharmaceutical products. The Hastings Center is a nonprofit, nonpartisan bioethics think tank based in New York.
“Millions of Americans are taking prescription drugs made in China and don’t know it and neither do their doctors,” Gibson said during her testimony. “These are prescription drugs in the legal supply chain that are distributed to U.S. hospitals, sold in corner drug stores and grocery store pharmacies, and distributed to military hospitals and clinics around the world. These are not the counterfeit drugs bought on the internet, or illicit drugs such as illegal versions of fentanyl.
“The public and many policymakers have been kept in the dark about U.S. dependence on China for medicine and the health security and national security risks of this dependence,” she added. “It’s time to turn on the lights.”
Blunt recently announced that he’s co-sponsoring a bipartisan bill, “Commission on America’s Medical Security Act,” to safeguard America’s medical supply chain and address medical equipment shortages.
In an interview with the Globe on Friday, he stressed the importance of evaluating the nation’s global supply chains, especially in the area of health, because America is adversely affected when the supply chain is disrupted.
“What we’re doing here is asking national labs to look at this, report back as quickly as they can on the dangers of the supply chain, the possible solutions, what we need to do to have more options,” Blunt said. “I think it’s still fine to buy things from other countries, but it’s probably much more acceptable to do that if you also have multiple other countries, or have backed ourselves up in our own country, with these things that relate to pharmaceuticals, to medical devices or to the products that provide health and safety, particularly for health care workers.”
The immediate goal is to examine the country’s dependency on foreign-made medical equipment, but Blunt said that eventually there also needs to be a significant look of how this affects our economy.
“We want a robust but a fairly quick report here on what do we need to do to begin to ensure that we solve this problem quickly, and if there’s another pandemic, then the problem has already been solved in advance,” he said. “I think the time element to get this done is in the very near future.”
Hawley proposed a similar bill, “Medical Supply Chain Security Act,” to help secure the U.S. medical product supply chain.
That bill would strengthen medical supply chains by giving the FDA authority to analyze sourcing locations of medical products and help more quickly bring products to market should shortages exist.
“The coronavirus has made clear just how dependent our supply chain is on China for medical products, devices, and worst of all, prescription drugs,” Hawley said in a statement emailed to the Globe on Friday. “We need to secure our medical supply chains by giving the FDA new authority to see what is being made in the United States so it can prepare for potential shortages and to fast-track substitutes for devices or drugs being made in China.”
The issue also has caught the focus of the Trump Administration. U.S. Sen. Marco Rubio, R-Fla., also raised concerns about diversifying the supply chain and reducing the U.S. reliance on imports, including from China, during a private lunch with President Donald Trump and GOP senators earlier this week.
“The coronavirus outbreak has been a wake-up call that we must combat America’s supply chain vulnerabilities and dependence on China in critical sectors of our economy,” Rubio said in a statement. He said the U.S. needs to take steps to increase domestic production by enforcing "Buy American" requirements for pharmaceuticals and medical supplies, as well as fast-tracking approval by the FDA of "critical products impacted by the coronavirus outbreak’s strain on the supply chain.”
Dr. Cornelius Clancy, a physician who is an associate professor of medicine and director of the XDR Pathogen Lab at the University of Pittsburgh in Pennsylvania and an infectious disease specialist, said in an email interview with the Globe on Friday that it's unknown just how big an impact COVOD-19 may have on the U.S. medical supply chain.
“Two big question marks and points of vulnerability are China and India,” he said. “China is the source of much of the raw material that goes into antibiotics and other drugs. India, then, is where many of the intermediate products are produced from these raw materials, before they are sent further along the chain to formulation as the final products that are given to patients. There is a several month lag from beginning of the process to final products. Therefore, it is possible that effects of the outbreak in China on drug production may not be felt in places like the U.S. for a few months yet.”
Clancy said at the same time, it’s unclear what the future dynamic of COVID-19 in China might be.
“Cases have tapered off dramatically, but will there be blips as people go back to their regular routines and work?” asked Clancy. “What will we see later in the year, if the virus manifests a seasonal pattern, as is likely?
“After the pandemic is under control, we are going to have to address these issues and make decisions about what might need to change to best assure our collective well-being and, even, our national security,” said Clancy. “I'm not sure we want a trade war with China or India over something like antibiotics, or to be so dependent upon outside sources for essential drugs or medical supplies.”
The Associated Press contributed to this report.