'Fail and fix' doesn't work as Rx for drug supply chain

The COVID-19 pandemic isn't over, but it's not too soon to start remedying the weak spots in the American health care system exposed by this historic health crisis. One that was made glaringly clear: a far-flung prescription drug supply chain increasingly vulnerable to shortages and foreign interference.

When hospitals delayed elective care in 2020, it wasn't just to keep rooms and beds open. It was also to conserve critical drugs, such as the sedatives given to COVID patients put on ventilators. The strategy, along with COVID's pattern of striking hard in certain areas and then moving on, fortunately mitigated pressure on drug supplies.

But recent congressional testimony by a University of Minnesota expert pointed out how things could have been much worse. "If all states would have had the same kind of surge as New York and New Jersey, at the same time, the U.S. would have had more shortages of medical and drug supplies, and those shortages would have been much more severe," according to the U's Stephen Schondelmeyer, a professor and director of the PRIME Institute in the College of Pharmacy. Schondelmeyer spoke and provided written testimony for a May 19 hearing of the Senate Committee on Homeland Security and Governmental Affairs. The focus: medical supply chain gaps during the pandemic. While other experts spotlighted shortages of protective gear, drug supply troubles are particularly frustrating because they've persisted for years.

"Over the past few years, the United States has had more than 250 drug shortages at any point, many for critical medications, including both acute drugs for treating emergency situations and chronic drugs for managing serious long-term conditions. ... Even though drug shortages have been recognized and tracked in the United States since before 2001, the situation has not significantly improved in more than two decades," a 2020 report by the U's Center for Infectious Disease Research and Policy (CIDRAP) found.

Schondelmeyer is a "co-principal investigator" for CIDRAP's Resilient Drug Supply Project. Well-known infectious disease expert Michael Osterholm, who serves as CIDRAP's director, is also one of the report's authors. In spotlighting this under-the-radar public health problem, the report provides a valuable public service.

Root causes include a questionable level of dependence on foreign drug manufacturers, the shift to "just-in-time inventory" vs. surge capacity, and the lack of visibility into "upstream" manufacturing. Global illness and shutdowns caused by COVID further stressed an unwieldy system. The concentration of manufacturers for certain drugs or active ingredients, in countries such as India or China, also left the United States vulnerable when countries considered limiting exports to conserve supplies for their own citizens.

Solutions are complex, but a smart start would be for Congress to authorize and fund a "national entity" that would analyze, predict and prevent shortages of critical drugs, Schondelmeyer said. Right now, the nation has a "fail and fix" mind-set that reacts to shortages. These eventually work themselves out, but that leaves patients without access to potentially lifesaving medications, and they may not have time to wait for resolution, he told an editorial writer.

In contrast, a new entity would build an in-depth map of the U.S. drug supply, conduct systematic analysis and coordinate across federal agencies to guard against future supply threats. So why not instead use the U.S. Food and Drug Administration (FDA) to do this? In addition to the FDA's sprawling mission, it "does not have authority to assess or act on economic or market-based factors" despite overseeing drugs' safety and effectiveness, according to Schondelmeyer's testimony.

The Senate committee's chair and ranking member, Sens. Gary Peters, D-Michigan, and Rob Portman, R-Ohio, admirably grasp the need to fix the medical supply gaps that surfaced in the pandemic. Peters has previously introduced two bills to address drug shortages. While he hasn't yet done so in the current congressional session, solutions and leadership are still needed.