There’s a Shortage of Life-Saving Drugs, Experts Are Concerned

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According to a recent Senate report (pdf), drug shortages increased to nearly 30 percent between 2021 and 2022.

“Drug shortages are increasing, lasting longer,” the Senate report reads. “The number of active drug shortages in the U.S. reached a peak of 295 at the end of 2022.”

Although drug shortages aren’t uncommon, the current shortage is sparking renewed interest among lawmakers.

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“Congress, the executive branch, and industry must work together to respond to this decades-long problem,” the report reads.

Doctors Lack the Most Effective Medicines

From basic asthma medication to certain chemotherapies, doctors are finding it increasingly challenging to acquire the medicine they need to treat patients. The shortage places doctors in complicated positions of prioritizing certain patients’ needs above others, an increased ethical burden for health care professionals.

In a 2022 study published in the American Society of Oncology’s JCO Oncology Practice journal, 75 percent of oncologists couldn’t prescribe the preferred chemotherapy agent because of shortages. When the preferred chemotherapy treatment isn’t available, doctors are forced to choose less effective alternatives, delay treatment, or reduce treatment dosages.

Yoram Unguru, an assistant professor of oncology at the Johns Hopkins Kimmel Cancer Center, wrote: “Surprisingly, little formal guidance exists to help oncologists make these tragic choices. Should we prioritize lifesaving chemotherapeutics, and if so, what criteria should we employ? Should children receive preference over adults? Perhaps patients with a better prognosis deserve priority access?”

Oncologists aren’t the only doctors facing difficult medical decisions.

Commonly used drugs such as albuterol, used when asthma patients experience life-threatening asthmatic attacks, are also in shortage. Amoxicillin, a generic antibiotic widely used to stop the spread of pneumonia, is needed. There’s a scarcity of epinephrine, which is used to treat severe allergic reactions. Children’s cold and flu medicine is also sparse.

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Drug products that have been in shortage for more than a decade. HSGAC Majority Staff Report

“The majority of these medications are relatively simple to make and have been available for decades. How is it that they are unavailable in the United States—the wealthiest country in the history of human civilization?” Dr. Alex Oshmyansky said on May 11 in front of Congress’s Subcommittee on Oversight and Investigations, which is investigating the root cause of drug shortages.

“The rates for morbidity and mortality for pediatric cancers in the U.S. have gone up in recent years, as the medications necessary to treat them are increasingly unavailable.”

Profit-Driven Motives?

While the reasons for the drug shortages are multifactorial, such as production malfunctions or insufficient raw materials, “the overarching theme is that almost all of these products are low-cost generic sterile injectables with low-profit margins,” according to Dr. William L. Dahut, chief scientific officer for the American Cancer Society.

“This means manufacturers have little incentive to invest in process upgrades, expanded capacity, or redundancy in production facilities,” he told The Epoch Times.

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“Companies make business decisions to discontinue manufacturing certain drugs, particularly generic drugs, based on profitability or other business considerations without always ensuring the continued manufacture of the drug elsewhere.”

The pharmaceutical industry doesn’t generate its desired profits by creating common drugs, even though they’re in high demand. What do produce higher profits are newer drugs.

In February, Akorn Pharmaceuticals, a drug company solely focused on making generic drugs, went bankrupt and was forced to shut down all U.S. operating sites. Akorn was the sole manufacturer of a particular form of albuterol used in hospitals for patients with serious respiratory complications.

“It’s important to note that these products are manufactured by private companies, and the FDA cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug,” the U.S. Food and Drug Administration (FDA) wrote on Twitter in response to news of Akorn’s closure.

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Because it’s outside of its statutory powers, the FDA doesn’t have the authority to compel drug companies to upregulate production. Democrats and Republicans are united in attempting to provide a solution to drug shortages. However, the solution is far from simple, given that the authority of agencies such as the FDA is a contentious topic among lawmakers.

But as the Senate’s report on drug shortages pointed out, neither the industry nor the federal government has end-to-end visibility of the pharmaceutical supply chain.

“This lack of transparency limits the federal government’s ability to proactively identify and address drug shortages,” the report reads.

The Problem With Pharma Middlemen

In the May 18 hearing, Rep. Morgan Griffith (R-Va.) drew attention to the controversial practices of pharmaceutical middlemen. Middlemen are group purchasing organizations and pharmacy benefit management firms (PBMs) that negotiate drug rebates and fees, create drug formularies and surrounding policies, and reimburse pharmacies for patients’ prescriptions.

They’re the link between pharmaceutical and insurance companies that have “enormous influence over the U.S. prescription drug system,” Federal Trade Commission Chair Lina M. Khan said in a statement.

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“Middlemen,” Griffith said, “do not care to look for ways to mitigate shortages.

“The four largest group purchasing organizations control 90 percent of the medical supply market and have massive market power. They could help end drug shortages by prioritizing generic drugs’ availability and quality. Instead, they use their market power to force ‘race-to-the-bottom’ pricing without consideration for quality or availability.”

The questionable methods of middlemen have come under scrutiny; the Federal Trade Commission started an inquiry in June 2022 to investigate their effect on the accessibility and affordability of pharmaceuticals. Initially, the inquiry included the six largest PBMs in the United States, but as of May 17, the commission included two more PBMs that will be required to provide information and records of their business practices.

“The largest PBMs are integrated with the largest health insurance companies and wholly-owned mail-order and specialty pharmacies. They influence which drugs are prescribed to patients, which pharmacies patients can use, and how much patients ultimately pay at the pharmacy counter,” the Federal Trade Commission stated on May 17.

Although the commission hasn’t stated when it'll release its findings, the inquiry “is aimed at shedding light on several PBM practices.” But for now, it appears that the solutions to end drug shortages remain in the dark.