What’s behind the drug shortages? Lawmakers seek answers from the FDA

Several popular drugs, such as amoxicillin and penicillin, remain in short supply, and two high-ranking Republican lawmakers want to know why. Rep. James Comer, R-Ky., chair of the House Committee on Oversight and Accountability, and Rep. Lisa McClain, R-Mich., chair of the Subcommittee on Health Care and Financial, demanded answers in a letter to FDA Commissioner Dr. Robert Califf.

“The FDA is failing to ensure vitally important pharmaceuticals remain on pharmacy shelves,” the letter said. “In light of these concerns, we request documents and a staff-level briefing to better understand the FDA’s response and mitigation strategies to improve and sustain the supply of high-quality, life-supporting medications available to Americans.”

At the time the letter was written, the FDA listed 128 drugs as being in short supply, according to the lawmakers. The medications treat a range of conditions such as infections, respiratory illnesses, heart failure and cancer. The letter cited 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.

“One way to improve pharmaceutical supply chain security is to increase domestic manufacturing capabilities,” the letter said. “However, in recent decades, pharmaceutical manufacturing — especially for inexpensive generic drugs — has moved offshore to maximize profit margins. In 2022, there were more than 4,000 facilities manufacturing prescription drugs for the United States, and 70% of those facilities were located in foreign countries.”

Comer and McClain also blamed provisions of the Inflation Reduction Act.

“The IRA’s price-control provisions will lead to less investment in domestic pharmaceutical production, further exacerbating supply chain insecurity,” they said in the letter. “Increased research and development costs limit pharmaceutical companies’ ability to invest in new drugs, ultimately stifling long-term investment in innovation.”

Related: ‘Severe’ prescription drug shortage: Governors urge Congress to take action

The FDA said it had received the letter and will respond directly to the committee. In mid-October, a group of House Democrats sent a letter to the FDA asking the agency to address the shortage of the drug Adderall, an ADHD medication for children.

“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 FDA spokesperson told The Hill.

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