The coronavirus has exposed a potentially serious vulnerability in the nation’s drug supply: it relies on overseas factories for some of the key ingredients of vital medications.
"If you're sick and need a medicine, you should be able to trust that that medication is going to work for you. And you shouldn't have to worry if it's going to be available," said Erin Fox, the Senior Director of Drug Information and Support Services at University of Utah.
Fox has been tracking drug shortages for nearly two decades. She says right now there are shortages of some 240 drugs in the U.S. The concern with coronavirus relates to Chinese-made active pharmaceutical ingredients - or APIs.
"Drugs that are used inside the United States, about 30 percent of the API is coming from Europe and then the rest is split between India and China. And so really the majority of a product is, is outside the US," Fox said.
While pharmaceutical manufacturers are required by law to report shortages of prescription drugs to the Food and Drug Administration, makers of the ingredients used in those drugs do not. So if factory shut-downs overseas lead to drug shortages here, because the API makers don’t have to disclose problems, US officials may not know until it’s too late.
"What we've identified through this episode is a critical choke point in the supply chain for pharmaceuticals and some critical pharmaceuticals," former FDA commissioner Dr. Scott Gottlieb warned senators on February 12th.
While pharmaceutical manufacturers are required by law to report shortages of prescription drugs to the Food and Drug Administration, makers of the ingredients used IN those drugs do not. So if factory shut-downs overseas lead to drug shortages here, because the API makers don’t have to disclose problems, US officials may not know until it’s too late.
The FDA has said it is “keenly aware that the outbreak will likely affect the medical product supply chain, including potential disruptions to suppliers [and] shortages of critical medical products in the U.S."
The FDA told Newsy since January 24th, it’s contacted over 180 manufacturers and reminded them they’re required to notify the FDA of any anticipated supply disruptions. The FDA also identified approximately 20 drugs whose active ingredients or finished products are solely sourced in China.
Newsy asked Fox about how soon a shortage could be. She said it depends on where API makers are in their manufacturing cycle because they'll have some material on hand.
"They might have three months on hand. They may have six months on hand," she said.
As far as drug prices, "sometimes prices do go up after shortages, but medicines aren't really a typical commodity that supply and demand works for," Fox said.
Some solutions are out there. U.S. Senators Susan Collins (R-ME) and Tina Smith (D-MN) introduced a bill which would require API manufacturers report interruptions or shortages the same way drug makers do. And sometimes, there are workarounds for patients like substituting medication. But that is not always the case.
"There are things like certain chemotherapy drugs that you need a specific drug for a specific indication or reason. And so if that drug is not being manufactured or is being, you know, doled out based on patient need or patient severity, that could be, you know, life-altering and potentially deadly for a patient," said Sarah Anderson, a professor at the Skaggs School of Pharmacy and Pharmaceutical Sciences.
Experts Newsy spoke with say if the supply chain does limit the availability of drugs, U.S. markets could see shortages anywhere between two weeks and six months from now, depending on how long factory shutdowns last in China.
Lindsey Theis
