As shortages of drugs like amoxicillin, penicillin, Adderall and certain chemotherapies continue to confound doctors and patients in the U.S., two high-ranking Republican lawmakers are pressing the FDA for answers.
In a letter (PDF) to FDA Commissioner Robert Califf, M.D., the chairman of the House Committee on Oversight and Accountability, James Comer, R-Kentucky, and Lisa McClain, R-Michigan, chairwoman of the Subcommittee on Health Care and Financial Services, requested documents and a staff-level briefing to parse through the agency’s shortage mitigation strategies.
Drug shortages have been a persistent thorn in the FDA’s side for the last several years and “far pre-date the COVID-19 pandemic,” Comer and McClain argue in their letter.
At the time of writing, the FDA listed 128 drugs as being in shortage, according to the lawmakers. The medications treat a range of conditions such as infections, respiratory illnesses, heart failure and cancer.
To hear Comer and McClain tell it, the FDA is “failing” to ensure those critical drugs remain on pharmacy shelves.
They cite several reasons for the current spate of shortages, apart from pandemic-related supply chain delays. Key among those causes is an “over-reliance” on foreign manufacturing, plus “surging” demand and “diminishing” production of generic medicines. The lawmakers called for more domestic drug manufacturing as one possible remedy to the shortage conundrum.
In fact, 70% of some 4,000 facilities manufacturing drugs for the U.S. were located overseas in 2022, Comer and McClain wrote.
“Overseas pharmaceutical production is risky, especially when the FDA does not adequately inspect offshore facilities,” they said.
Tackling drug shortages in the U.S. has been a common theme this year.
Back in August, Califf opined on drug shortages during a presentation of the Alliance for a Stronger FDA, noting that the “fundamental problem” is that “we essentially have two drug industries in the U.S.”
He cited an “innovator industry” of branded drugs where “the prices are too high,” and the generics industry, where “a lot of the prices are too low.”
About a week after that, 11 Republican governors sent a letter to Congress demanding action on the protracted supply squeeze. Much like Comer and McClain, the governors blamed the issue in large part on the offshoring of drug manufacturing for U.S.-bound medicines.
“This limited supply chain creates a national security risk and leaves America competing with other nations for essential resources,” the joint letter read.
Meanwhile, the FDA itself has argued that it can’t stop the trend of medication supply shortfalls on its own. While the agency has a hand in mitigating cancer drug shortages, its abilities are limited, Richard Pazdur, M.D., the director of the FDA’s Oncology Center of Excellence, told The Cancer Letter in May. He flagged a failure by the industry to invest in building capacity as the root cause of shortages. As it stands, the FDA can’t require a company to manufacture a drug, nor can it make a manufacturer report spikes in demand that could fuel shortages, Pazdur explained.