Comer, McClain Open Probe into FDA’s Response to National Drug Shortage

“The FDA is failing to ensure vitally important pharmaceuticals remain on pharmacy shelves.”

WASHINGTON—House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) and Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain (R-Mich.) today are calling on the U.S. Food and Drug Administration (FDA) to provide information to understand the FDA’s response to a growing number of critical drug shortages delaying and prohibiting American patients from receiving lifesaving medical care. In a letter to FDA Commissioner Dr. Robert Califf, the lawmakers request documents and a staff-level briefing to understand the FDA’s role in monitoring and preventing drug shortages.

“At the time of this letter, the FDA lists 128 drugs currently in shortage on its drug shortage database. Current shortages include important drugs commonly used to treat infections, respiratory illnesses, heart failure, psychiatric conditions, and cancer, and include drugs such as amoxicillin, penicillin, albuterol, Adderall, and cisplatin/carboplatin. Earlier this year, there was a shortage of children’s acetaminophen and ibuprofen. The cancer drug shortage has gotten so severe that the FDA temporary authorized the importation of drugs produced by non-FDA approved Chinese manufacturers. The FDA is failing to ensure vitally important pharmaceuticals remain on pharmacy shelves,” the lawmakers wrote.

According to a July 2023 national survey, up to eight in ten hospitals and pharmacists are rationing drugs and delaying appointments as they battle a medicine shortage. The shortage of critical drugs pre-dates the COVID-19 pandemic and has been worsened by factors including an overreliance on manufacturing facilities located in foreign countries. Government price controls in Democrats’ Inflation Reduction (IRA) will further aggravate drug shortages by exacerbating supply chain insecurity and leading to less investment in new cures in the long-term.

“The FDA’s problems with critical drug shortages far pre-date the COVID-19 pandemic. There are a variety of reasons for the current state of drug shortages apart from pandemic supply chain delays, including an over-reliance on offshore manufacturing facilities, surging demand for pharmaceuticals, and diminishing manufacturing of generics. […] Drug shortages will only be worsened by provisions in the Inflation Reduction Act (IRA) that mandate government price controls for prescription drugs. Price controls ultimately limit profitability for pharmaceutical companies to the detriment of investment in new therapies and treatments,” the lawmakers continued. “It is of vital importance that the FDA monitor and prevent future drug shortages to maintain Americans’ health and quality of life.”

Read the letter to FDA commissioner Dr. Califf here.