On Sept. 14, the House Energy and Commerce Health Subcommittee held a legislative hearing titled “Legislative Proposals To Prevent And Respond To Generic Drug Shortages.” During the hearing, members discussed several legislative proposals intended to address generic drug shortages and ensure access to care for patients, including full Committee Chair Cathy McMorris Rodgers’ (R-Wash.) Stop Drug Shortages Act. The AAMC previously expressed its opposition to this proposal in an Aug. 23 letter to Rodgers [refer to Washington Highlights, Aug. 31]. In its comments, the association outlined concerns that these policies would increase prescription drug costs and reduce patients’ access to care by weakening the 340B Drug Pricing Program and the Medicaid Drug Rebate Program.
During the hearing, the subcommittee heard testimony from several experts on the pharmaceutical supply chain, including Melissa Barber, PhD, postdoctoral fellow at the Yale School of Medicine and Yale Law School. In her testimony, Barber emphasized that measures included in the Stop Drug Shortages Act are “poorly targeted” to address shortages, noting, “raising the price of medicines in shortage, medicines with supply chain issues, and sterile injectable medicines is not likely to incentivize manufacturers to invest in improving quality and building resilience in their supply chains.” Several Democratic members of the subcommittee echoed these concerns, noting that Rodgers’ proposal would raise prices for patients while potentially incentivizing manufacturers to keep their drugs in shortage.
The subcommittee also examined several other measures designed to address the root causes of drug shortages, including the Drug Shortage Prevention Act of 2023 (H.R. 3008), the Drug Origin Transparency Act of 2023 (H.R. 3810), the Ensuring Access to Lifesaving Drugs Act of 2023 (H.R. 3793), and the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 (H.R. 167). Members of the subcommittee struggled to identify bipartisan policy solutions, with Republicans favoring economic incentives and regulatory flexibilities for generic manufacturers and Democrats advocating for expanding the Food and Drug Administration’s authority to monitor and respond to emerging shortages.