Drug shortage can put patients' lives at risk, experts warn
National shortage of over-the-counter and prescription drugs for health issues such as asthma, ADHD or cancer have been troubling patients and medical personnel for more than a year -- and at a hearing this week, lawmakers and experts discussed the threats that patients face without having access to the drugs they need.
At the House Ways and Means Committee hearing earlier this week, expert witnesses -- practitioners, researchers and pharmaceutical company executives -- spoke about the pressing issue the shortages pose to patients' lives and health and possible ways the Congress can tackle it.
"We could have patients -- cancer patients or pediatric patients, or other patients -- without the drugs they need," Stephen Schondelmeyer, director of the PRIME Institute at the University of Minnesota's College of Pharmacy, said at the hearing.
Shortages of some drugs have been an ongoing problem in the U.S. for more than a decade and were recently exacerbated by COVID-19, according to a report by the Senate Homeland Security Committee in March. Lack of necessary medication means patients have to get delayed treatments, substitutions or sometimes no treatment at all, the report found.
The shortage can hurt patients financially as well, Schondelmeyer said, as they have to turn to alternate products that can cost more.
There are more than 250 active pharmaceutical shortages as of early February, according to the American Society of Health-System Pharmacists. The state of chemotherapy and hormonal drug shortages were characterized as the most severe shortages in 2023.
Patients in the rural areas may experience even more difficulty with drug access, Tennessee Oncology Chief Medical Officer Dr. Stephen Schleicher said at the hearing. In remote regions it's harder to find substitutions or reliable distributors, he added.
Overdependence on international suppliers -- such as India and China -- came up as a frequent cause of the shortages. Supplying raw materials and active pharmaceutical ingredients from other countries can be geopolitically risky, experts said.
Rep. Brad Wenstrup, R-Ohio, said the drug shortages are a national security concern.
"These drug shortages, these vulnerabilities in our supply chain, they put our national security at risk," Wenstrup said. "They put our national health security at risk."
The U.S. depends on foreign providers for some of the active pharmaceutical ingredients necessary to give medications their desire effect. Almost half of pharmaceutical products consumed in the U.S. come from India and China, Schondelmeyer said in his testimony.
"The U.S. has raw, raw materials, carbon and oxygen, and chemicals," he said "But we don't have a lot of the formulated ingredients to make the drugs that we have."
While the number of U.S. production facilities has dropped by half in the past decade, the numbers of those plants in China, India, Israel and Taiwan have been growing.
India and China have been favorable for drug production because of low labor and production costs, Schondelmeyer said. They also have fewer environmental regulations that allow toxic pharmaceutical pollution -- including explosive chemicals -- caused by manufacturing, added Rep. David Schweikert, R-Ariz.
"We almost don't have a disposal mechanism from the toxic byproducts," he said. "And [manufacturers] produce some really nasty stuff."
Another risk with supplying the materials from Asia is lack of U.S. supervision. The FDA, which has the authority to conduct inspections on U.S. production sites, has to jump through several hoops to inspect international suppliers' sites, said Jeromie Ballreich, associate research professor at Johns Hopkins Bloomberg School of Public Health.
The limited regulation brings up quality issues, Schondelmeyer said, citing the recent incident where contaminated eye drops manufactured in India led to deaths, blindness and several people who had to have their eyeballs surgically removed.
"If [the FDA] is not in those labs in China -- and especially since the pandemic -- it is a problem," Wenstrup said.
There's also an issue with transparency: how much each manufacturing plant contributes to the production, said Dr. Julie Gralow of the American Society of Clinical Oncology. Without knowing how much raw material each manufacturer provides for production of a certain drug, it becomes hard to predict how an issue at one facility can impact drug availability, Gralow said.
Schondelmeyer likened it to relying on enemies in wartime.
"We don't rely on other countries to make bullets … when we fight wars, especially our sworn enemies," he said. "We want to make sure that the drugs we need to keep our public and our military healthy are coming from sources that we have control of."
