House GOP opens probe into FDA response to drug shortages

House Republicans are launching an investigation into how the Food and Drug Administration (FDA) is responding to the nation’s growing prescription drug shortages.

In a letter to FDA Commissioner Robert Califf, Republican members of the House Oversight and Accountability Committee requested documentation and staff-level briefings to understand FDA’s role in monitoring drug shortages and mitigation strategies. I asked for the event to be held.

The letter was signed by Committee Chairman James Comer (R-Ky.) and Health Subcommittee Chair Lisa McClain (R-Mich.).

The FDA’s drug tracker lists about 130 drugs currently in short supply, including generic cancer drugs, amoxicillin, albuterol and Adderall. Earlier this year, there was a shortage of acetaminophen and ibuprofen for children.

Earlier this year, the FDA temporarily allowed imports of cancer drugs made by Chinese manufacturers that are not FDA-approved to ease the shortage.

“FDA is failing to ensure that vital medicines remain on pharmacy shelves,” the lawmakers wrote, adding that the agency’s shortage problems predate the coronavirus pandemic.

“There are a variety of reasons for the current drug shortage situation, beyond supply chain delays due to the pandemic, including over-reliance on overseas manufacturing facilities, a surge in demand for drugs, and a decline in generic drug manufacturing.” the lawmakers wrote.

The FDA said it received the letter and would respond directly to the committee.

“While the FDA does not manufacture drugs and cannot require drug companies to make drugs, increase production of drugs, or change the way drugs are distributed, the public believes that the FDA “We want you to be reassured that we are working closely together. Supply chains need to understand, mitigate, and prevent or mitigate the impact of intermittent or reduced supplies of certain products,” an agency spokesperson said. said in a statement to The Hill.

Comer and McClain asked for a staff-level briefing by Nov. 9 and documentation by Nov. 16.