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.
BARACK OBAMA HAS BEEN WORKING FOR MONTHS TO SHAPE THE WHITE HOUSE’S AI APPROACH
“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.
A spokesperson for the FDA told the Washington Examiner that the agency is “committed to partnering across government, academia, and industry to strengthen and diversify the supply chain, further address drug shortages and ensure Americans continue to have access to drugs that are of high quality, safe and effective.”
“While the agency does not manufacturer drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug, 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,” said the spokesperson.
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.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
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.
HHS and the White House have not responded to the Washington Examiner‘s request for comment.
