Comer, McClain Probe Shortages of Schedule II Drugs, including Adderall

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.) are furthering their investigation into the growing number of critical drug shortages impacting Americans’ medical care. In a letter to Drug Enforcement Administration (DEA) Administrator Anne Milgram, the lawmakers request documents and communications related to DEA’s impact on and response to the prolonged shortages of Schedule II drugs, including Adderall.

“Due to spiking demand, pharmaceutical manufacturers producing at full capacity—sometimes more—are unable to meet the demand for more prescriptions amid manufacturer exits. Additionally, in the last four years, there are fewer manufacturers of Adderall and generic alternatives. Despite increased demand and fewer manufacturers, DEA has not provided manufacturers an increased APQ.  As a result, shortages of these drugs have remained for more than a year and a half,” the lawmakers wrote.

After significant pushback from stakeholders and ongoing shortages, DEA announced that manufacturers must submit quarterly requests to DEA, a shift from annual requests. This change only made it more difficult for manufacturers and exacerbated shortages. Recognizing these issues, DEA has again altered the required frequency for quota allocation, shifting from quarterly to semi-annually. This recent change highlights ongoing uncertainty for manufacturers, which is likely to extend shortage concerns.

“DEA’s mishandling of the APQ system resulting in shortages is not a new problem.  In a 2015 Government Accountability Office (GAO) report, DEA’s quota process was found to be ineffectively administered, leading to drug shortages. This report found that DEA consistently missed required time frames for establishing quotas for Schedule II substances and lacked performance measures to ensure quotas were adequate and meeting demand,” the lawmakers continued. “It is critical that DEA work with pharmaceutical manufacturers, not against them, to provide regulatory support that reduces drug shortages and prevents abuse.”

Chairman Comer and Subcommittee Chairwoman Lisa McClain are investigating a growing number of critical drug shortages in the United States. In November 2023, the lawmakers opened a probe into the Food and Drug Administration’s (FDA) response to critical drug shortages. Oversight Committee lawmakers questioned FDA Commissioner Califf about multiple crises at the FDA, including essential drug shortages, at a hearing in April.

Read the letter to Administrator Anne Milgram here.