Rising Rate of Drug Shortages Is Framed as a National Security Threat
An increase in shortages of inexpensive yet critical medications is forcing hospitals to make “horrible” choices and is amounting to a national security threat, according to a report and testimony at a Senate homeland security hearing on Wednesday.
A report prepared for the hearing found that drug shortages increased by nearly 30 percent last year compared with 2021, with an average shortage lasting 18 months and some spanning 15 years. They include common antibiotics, anesthetics and sterile fluids used to keep intravenous drug tubes clean.
The problems were pegged to economic drivers, an opaque supply chain and the fact that as much as 80 to 90 percent of certain products are made overseas, said Senator Gary Peters, a Democrat of Michigan and chairman of the Senate Committee on Homeland Security and Government Affairs.
“Taken together, these underlying causes not only present serious concerns about providing adequate care to patients, they also represent serious national security threats,” Mr. Peters said.
Dr. Andrew Shuman, a cancer surgeon in Michigan, told senators at the hearing that shortages in his field have come to “represent a tragedy that’s happening in slow motion.”
Health Care in the United States
Dr. Shuman, who holds leadership roles at the University of Michigan hospital system and the Veterans Affairs Ann Arbor Healthcare System, said one cheap and established cancer drug called etoposide was recently in scarce supply. He had to weigh which patients, young and old, with lung, brain and testicular cancer, should receive the limited number of doses.
“As a doctor who has devoted my life to fighting cancer, it’s hard to express how horrible that is,” Dr. Shuman said.
The hospital pharmacist managed to stretch the supply on hand, but “our pharmacists should not be desperately trying to squeeze out a few last drops when a life may be on the line,” Dr. Shuman said.
One expert outlined the efforts of the U.S. Pharmacopeia, a nonprofit focused on a safe drug supply, to map the dynamics and causes of shortages. That group found that there is a higher risk of shortages for drugs with a low price, complex manufacturing process or quality problems marked by a history of recalls, said Vimala Raghavendran, vice president of informatics product development for the U.S.P.
Those factors can add up in interesting ways: Many of the cheapest products tend to be manufactured in regions of India and China where they are inexpensive to produce, but the concentration of facilities creates an extra layer of vulnerability to problems such as natural disasters or political unrest.
Ms. Raghavendran said efforts to diversify the locations for production were important, but warned that bringing the manufacturing to the United States would not be the only way to fix the issue. She noted the recent bankruptcy of a U.S. generic drugmaker. The abrupt closure of Akorn Pharmaceuticals last month has been linked to the worsening of an albuterol shortage.
Witnesses also emphasized the need for more transparency into drug supplies. Policymakers are “flying blind” when it comes to the sources of critical ingredients, often referred to as A.P.I., or active pharmaceutical ingredients, Ms. Raghavendran said.
While the Food and Drug Administration gets some data on those active ingredients, the agency acknowledged to Senate staff that the data was not kept in a usable format, but rather “buried in PDFs within individual drug applications,” the Senate report says.
Erin Fox, an expert at the University of Utah who tracks drug shortages, said another gap in information was critical, as well: There is no data on drugmaker quality. Such information might be used to reward the most scrupulous suppliers and help them expand production. Yet while the F.D.A. “sees really clear quality differences between products and manufacturing sites,” the information is confidential and not available to drug buyers.
“There’s really no incentive for one company to do a better job,” Dr. Fox said. “If one company did do a better job, we have no way of knowing that.”
The matter deserves attention, she said: “Unlike other products, people’s lives are at stake.”
Dr. Shuman, the cancer surgeon, cited other troubling shortages, including of eye drops that “literally keep people from going blind that cost a few dollars a month.” He said patients with glaucoma who do not get the drops could be faced with surgery instead.
Those critical but cheap treatments in short supply point to a need for incentives or subsidies to companies that make them, Dr. Shuman said, given that “drug pricing structures are not always reflective of their value to patients.”
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