House Republicans on Friday launched an investigation into the Food and Drug Administration's handling of the long-term prescription drug and pharmaceutical product shortage.
Oversight Chairman James Comer (R-KY) and Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain (R-MI) asked FDA Commissioner Robert Califf Friday how the agency is handling the problems that have contributed to the nearly 130 drugs currently listed as in critical short supply.
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"The FDA is failing to ensure vitally important pharmaceuticals remain on pharmacy shelves," wrote Comer and McClain in a letter to Califf. "It is of vital importance that the FDA monitor and prevent future drug shortages to maintain Americans' health and quality of life."
Various drugs to treat infections, cardiovascular problems, psychiatric conditions, and respiratory illnesses are in short supply. Other products necessary for in-patient treatment — including sterile water for wound irrigation, sodium chloride for IV fluids, and dextrose for blood sugar stabilization — are also facing supply shortages.
Cancer drugs, in particular, are in such short supply that the FDA has temporarily authorized the medical industry to import non-FDA-approved drugs from China.
Comer and McClain note that the issues of pharmaceutical supply, including over-reliance on offshore manufacturing and surging demand, were only exacerbated by the COVID-19 pandemic. They argue that increasing domestic manufacturing must be a part of the strategy to not only boost production but also ensure product safety.
The Republican Oversight Committee leadership also argues that the Medicare Drug Price Negotiation program in the Inflation Reduction Act, which gives the Centers for Medicare and Medicaid Services the ability to set purchase prices for Medicare, will worsen existing shortages.
"Price controls ultimately limit profitability for pharmaceutical companies to the detriment of investment in new therapies and treatments," wrote Comer and McClain. "The IRA's price control provisions will lead to less investment in domestic pharmaceutical production, further exacerbating supply chain insecurities."
In August, 11 Republican governors petitioned Congress for assistance in dealing with the drug shortage problem, saying that healthcare infrastructure in the states can only go so far in mitigating supply chain vulnerabilities without federal assistance.
House Energy and Commerce Chairwoman Cathy McMorris Rodgers (R-WA) has made formulating new policies to tackle drug shortages a priority for this legislative session. Proposals on the table include strengthening the enforcement capacities of the Department of Health and Human Services to enforce oversight of the FDA and requiring better record-keeping from the FDA and drug manufacturers about potential supply chain disruptions.
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Comer and McClain requested in their letter that Califf provide to the committee by Nov. 16 all documents and communications related to the FDA's plans for investing in pharmaceutical data and for incentivizing pharmaceutical manufacturing. The Committee also requested a meeting with FDA staff regarding chronic drug shortages by Nov. 9.
FDA, HHS, and the White House have not responded to the Washington Examiner's request for comment.