Drug shortages have been on the rise for several years, with an estimated 210 drugs currently at risk or not readily available for U.S. hospitals, according to the national database maintained by the American Society of Health System Pharmacists (ASHP). The Food and Drug Administration (FDA) also states that drug shortages have grown more persistent since 2014 with many shortages lasting multiple years.
Drug shortages impact every single segment of the healthcare ecosystem and are a major driver of skyrocketing costs, contributing to half a billion dollars in increased healthcare expenditures annually. Drug shortages also result in increased potential for adverse events, and consequently increased costs to the healthcare system such as increased hospital days, due to the unavailability of a critical medication.
S.2723 – The Mitigating Emergency Drug Shortages (MEDS) Act
The MEDS Act builds upon the prior work of Congress to provide additional authority to the FDA to help mitigate drug shortages and develop market-based incentives to help ensure a stable supply of medications critical for patient care. Specifically, the MEDS Act:
- Creates a priority pathway for the review of drug shortage applications;
- Requires the Secretary to develop a report to Congress with recommendations to incentivize manufacturers to enter the market for shortages as well as incentives to encourage the domestic manufacturing of finish dose formulations and active pharmaceutical ingredients (API);
- Strengthens FDASIA Title X reporting requirements to include full disclosure of the problems resulting in the shortage, information concerning the extent of the shortage, its expected durations, and other information the Secretary may require;
- Extends FDASIA Title X reporting requirements to API manufacturers;
- Requires manufacturers to report redundancy and contingency plans to ensure ongoing supply;
- Requires the Secretary to develop a report to Congress with recommendations on consumer notification of shortages;
- Studies FDA’s efforts to improve intra-agency and inter-agency coordination to account for the downstream impact of cGMP violations, facility shutdowns, etc on shortages;
- Expands the FDA drug shortage list to include regional shortages as well as shortages based on strength and dosage form; and
- Examines the risk to national security as a result of shortages.
“S. 2723 — 116th Congress: Mitigating Emergency Drug Shortages Act.” http://www.GovTrack.us. 2019. November 13, 2019 <https://www.govtrack.us/congress/bills/116/s2723>
We applaud the bipartisan commitment of Senators Susan Collins, R-ME and Tina Smith D-MN in addressing drug shortages and decreasing healthcare costs while improving patient outcomes.