Lawmakers say reliance on China exacerbates drug shortages
Nearly 90 percent of facilities that produce active ingredients for generic drugs are outside the U.S., with the majority in India and China
Lawmakers say the worsening drug shortage in the United States is hurting the American health care system and called for shifting more manufacturing from China to the United States to help alleviate the problem during a Senate hearing Wednesday.
The number of active drug shortages in the U.S. reached a peak of 295 by the end of 2022. Between 2021 and 2022 new drug shortages increased by nearly 30 percent, said Sen. Gary Peters, D-Mich., the chairman of the Senate Homeland Security and Governmental Affairs Committee.
The shortages touch all kinds of drugs — from everyday hospital needs like saline or anesthetics to critical cancer treatments — and has forced physicians and pharmacists to make tough decisions, with committee witnesses describing being forced to decide whether to treat a young baby with neuroblastoma or an elderly woman with lung cancer due to limited drug supplies.
"Our pharmacists should not be trying to squeeze out a few last drops when lives are on the line," said Andrew Shuman, an associate professor of Otolaryngology-Head and Neck Surgery and chief of the Clinical Ethics Service Center for Bioethics and Social Sciences in Medicine at the University of Michigan Medical School. "All patients affected by drug shortages deserve better."
Shortages also cause physicians to, as one witness said, “macgyver,” or improvise different treatment regimens or options when drugs are not available — a solution with potentially dangerous results. While major hospital institutions have more resources to drum up supplies, smaller care centers struggle more.
"When you're baking, you have a list of ingredients and you need all the ingredients for that product to be exactly what it is. When you make a substitution, you don't necessarily know how well that's gonna work. But here you're not going to end up with a dry cake, you're going to end up with a child whose cancer has not been cured," Shuman said.
Nearly 90 percent of facilities that produce active pharmaceutical ingredients for generic drugs are outside the U.S., with the majority in India and China.
Peters said such an overreliance on other countries hampered the country's pandemic response, as the U.S. fell short on personal protective equipment, ventilators and critical drugs.
He said he wants to see more pharmaceutical ingredients produced in the U.S., and said not doing so is a national security risk.
But ranking member Rand Paul, R-Ky, said the blame should not be placed on foreign producers, pharmaceutical companies or hospitals but rather the American government.
"It's no coincidence that the rise in drug shortages correlates with the expanded regulatory reach of the FDA," Paul said.
Paul pointed to payer price controls on drugs as reason for shortages, saying if prices could fluctuate with demand, it could encourage drug makers to produce more so supply meets demand.
Lawmakers repeatedly focused on American reliance on China for pharmaceuticals, with Sen. James Lankford, R-Okla., worrying that if China invades Taiwan and the U.S. stops importing drug ingredients from China it could upend the U.S. health care system.
Erin Fox, an associate chief pharmacy officer of shared services and adjunct professor at the College of Pharmacy at the University of Utah, called for increased transparency to determine which products the U.S. relies on from China.
And Vimala Raghavendran, vice president of informatics product development at U.S. Pharmacopeia, said while there's anecdotal evidence that while the United States relies too heavily on China for key raw chemicals to make drugs in the U.S., there have been no conclusive studies on the subject — and such data is sorely needed.
Companies that manufacture in China are not required to reveal which products they manufacture overseas and where, Fox said.
"Without that information, we really are vulnerable," she said.