U.S. Sen. Susan Collins (R-ME), chairman of the U.S. Senate Special Committee on Aging, recently introduced legislation aimed at reducing drug shortages by increasing incentives to ensure that the supplies of critical drugs are available to treat various illnesses.
“I often hear from patients, pharmacists, and physicians who find themselves caught in the middle of a drug shortage, with very little certainty of when the problem might be resolved,” Sen. Collins said. “Physicians and hospitals try their best to manage these shortages behind the scenes but are understandably frustrated.”
Sen. Collins sponsored the Mitigating Emergency Drug Shortages (MEDS) Act, S. 2723, on Oct. 29, a measure that was cosponsored by U.S. Sen. Tina Smith (D-MN). The bill, which has been referred to the Committee on Health, Education, Labor, and Pensions, would amend the Federal Food, Drug, and Cosmetic Act to reduce drug shortages.
Such shortages add roughly $230 million annually to U.S. drug costs and $216 million annually in increased labor costs as medical professionals spend more time finding alternative treatments and medication sources, according to Sen. Collins’ office.
“Increasing the affordability and accessibility of prescription drugs is one of my top priorities, and I urge my colleagues to join Senator Smith and me in combatting this stubborn problem,” Sen. Collins said.
The MEDS Act would prioritize the review of drug applications and inspections and implement manufacturer reporting requirements for active pharmaceutical ingredients, which would instruct manufacturers to provide full disclosure on the problems resulting in the shortage, the extent of the shortage and its duration, and the expected impact on pharmacy distribution and availability, according to a summary of the bill provided by the senator’s staff.
The legislation would also require manufacturers to report contingency and redundancy plans to the U.S. Food and Drug Administration (FDA) concerning vital, life-supporting medications. Modifications to the drug shortage list maintained by the FDA would also be expanded to include regional shortages.
Additionally, the MEDS Act would require the U.S. Government Accountability Office to produce a report examining the FDA’s intra-agency coordination and communication. The Department of Health and Human Services and the Department of Homeland Security would also be required to conduct a risk assessment of national security threats associated with inadequate distribution of critical drugs.
The MEDS Act is supported by the American Hospital Association, the American Society of Anesthesiologists, the American Society of Clinical Oncology, the American Society of Health-Systems Pharmacists, and the Institute for Safe Medication Practices.