Washington, D.C. – House Republicans on the Oversight Committee announced on Friday that they have opened an investigation into the causes behind the ongoing shortage of critical prescription drugs and pharmaceutical products in the United States.
In a letter to Food and Drug Administration (FDA) Commissioner Robert Califf, Oversight Chairman James Comer (R-KY) and Health Subcommittee Chairwoman Lisa McClain (R-MI) demanded information on how the FDA is handling the shortages, which currently impact nearly 130 different medications.
“The FDA is failing to ensure vitally important pharmaceuticals remain on pharmacy shelves,” the Republican lawmakers wrote. “It is of vital importance that the FDA monitor and prevent future drug shortages to maintain Americans’ health and quality of life.”
Shortages Span Wide Range of Critical Medications
The shortages have affected a broad range of medications used to treat infections, cardiovascular conditions, psychiatric illnesses, respiratory diseases, and other serious health problems.
In addition, products like sterile water for wound cleaning, IV saline solution, and dextrose used for diabetes management have also faced supply constraints. Cancer medications have been particularly impacted, with the FDA resorting to temporary emergency imports of non-FDA-approved drugs from China to help fill the gap.
The supply challenges for many pharmaceuticals predate the COVID-19 pandemic but were exacerbated over the last three years by pandemic disruptions. In their letter, Comer and McClain argued that increasing domestic manufacturing must be part of any strategy to boost production volumes and improve reliability.
“Price controls ultimately limit profitability for pharmaceutical companies to the detriment of investment in new therapies and treatments,” they wrote, referencing drug price negotiation policies in the Inflation Reduction Act passed last year. “The IRA’s price control provisions will lead to less investment in domestic pharmaceutical production, further exacerbating supply chain insecurities.”
Investigation Seeks Answers on FDA’s Role
The Republican investigation aims to understand what role failures or shortcomings at the FDA may have played in the shortages crisis.
“The public should rest assured the FDA is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products,” an FDA spokesperson stated.
But Comer and McClain counter that more accountability and transparency is needed around the FDA’s management of the situation. Their letter demands that Commissioner Califf turn over internal assessments on the shortages, plus documentation of communications between the FDA and drug manufacturers related to present or future supply disruptions.
“It is imperative the American people understand what actions FDA is taking to anticipate, identify, and resolve current and future drug shortages,” they wrote.
Democrats Also Concerned, But Differ on Solutions
While the investigation comes from GOP leadership, Democrats have also raised concerns about persistent drug shortages that put patients’ health at risk.
“No one should have to worry about access to life-saving medications,” said Rep. Lori Trahan (D-MA), who serves on the House Energy and Commerce Health Subcommittee.
But Democrats disagrees with the GOP assertion that price negotiation policies are to blame. “Price gouging is more likely the culprit than negotiated fair prices,” argued Rep. Peter Welch (D-VT).
To address shortages, House Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) has proposed strengthening the HHS Secretary’s authority to oversee and hold the FDA accountable. Improved data collection on potential supply chain issues has also been suggested.
Shortages Creating Problems for Hospitals, Clinics
Healthcare providers around the country are scrambling to deal with the lack of critical medications.
“We’ve taken extraordinary measures to ensure we have necessary backup supplies and alternate medication options when possible,” said Dr. Michelle Hood, Chief Operating Officer at a major Atlanta hospital group. “But this is putting significant strain on staff and budgets.”
A survey by the American Society of Health-System Pharmacists (ASHP) found shortages are leading to medication errors, adverse patient outcomes, and higher healthcare costs. The ASHP has called for a systematic approach to identify risks early and mitigate impacts.
For now, the FDA recommends that providers avoid stockpiling drugs that are in shortage to prevent hoarding behaviors that can worsen access issues. Patients are urged to consult doctors before changing medication regimens due to shortages.
“We will continue collaborating across the supply chain to help prevent shortages,” said FDA Commissioner Califf. “And we hope this investigation sheds more light on finding solutions.”
The House Oversight Committee has requested a response from the FDA within two weeks about the agency’s shortage prevention plans and strategies.