House GOP opens probe into FDA response to drug shortages

House Republicans are launching a probe into how the Food and Drug Administration (FDA) is responding to a growing number of prescription drug shortages in the country. 

In a letter sent to FDA Commissioner Robert Califf, Republicans on the House Committee on Oversight and Accountability requested documents and a staff-level briefing to understand the agency’s role in monitoring drug shortages and mitigation strategies. 

The letter was signed by committee Chairman James Comer (R-Ky.) and health subcommittee Chairwoman Lisa McClain (R-Mich.). 

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

Earlier this year, the FDA temporary authorized the importation of cancer drugs produced by non-FDA approved Chinese manufacturers to help ease the shortages. 

“The FDA is failing to ensure vitally important pharmaceuticals remain on pharmacy shelves,” the lawmakers wrote, adding that the agency’s problem with shortages predates 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,” the lawmakers wrote.

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

“While the agency does not manufacture 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,” an agency spokesperson said in a statement to The Hill.

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