March 05, 2020
Amidst Coronavirus Outbreak ASA and Stakeholder Groups Urge Key Leaders to Advance Legislation Addressing Drug Shortages
The American Society of Anesthesiologists (ASA), along with several stakeholder organizations sent a joint communication to the Senate Committee on Health, Education, Labor and Pensions (HELP) in support of S. 2723, the Mitigating Emergency Drug Shortages (MEDS) Act, urging the Committee to advance this critical legislation expeditiously. ASA also joined a formal communication to House leaders in support of newly introduced legislation, The Preventing Drug Shortages Act.
These bills include key policy recommendations to continue to combat drug shortages which have grown more persistent since 2014 and are now more pressing amid the nation’s current public health challenges.
Introduced by Senators Collins and Smith in October 2019, the MEDS Act provides increased authority to the U.S. Food and Drug Administration (FDA), enhanced manufacturing reporting requirements and new market-based incentives to help mitigate the risks drug shortages pose to both patients and the health care system. ASA and other stakeholders worked closely with the Senators to ensure the bill included recommendations from ASA’s September 2018 Summit.
This week, U.S. Representatives Peters, Engel, Eshoo, Schrader, Guthrie, Hudson, McCaul, and Bilirakis joined their Senate colleagues in addressing drug shortages by introducing ASA-supported legislation, The Preventing Drug Shortages Act. ASA believes both proposals are a step forward in addressing our nation’s drug shortage crisis and support our goal of ensuring patients have reliable access to the medications they need.
ASA is pleased discussions surrounding the importance of advancing the MEDS Act continued during this week’s Senate HELP Committee hearing titled “An Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the Novel Coronavirus.”
ASA recognizes that as the United States accelerates efforts to respond to the COVID-19 outbreak, concerns with potential drug shortages have heightened. In recent years, drug shortages have been on the rise and continue to impact every aspect of the health care ecosystem; they are a driver of skyrocketing healthcare expenditures and result in increased potential for adverse events.
The MEDS Act and The Preventing Drug Shortages Act provide additional authority to the FDA to prevent drug shortages with the following provisions:
- Strengthens reporting requirements to disclose causes resulting in the shortage and expected duration of shortages
- Extends reporting requirements to active pharmaceutical ingredient (API) manufacturers and contract manufacturers
- Requires manufacturers to develop risk management plans to ensure ongoing supply; and
- Develops recommendations to incentivize manufacturers to enter the market for drugs in shortage
ASA applauds the bipartisan efforts in both the Senate and House of Representatives to prevent further drug shortages and will continue to work with Congress to advance legislation that addresses this critical issue impacting patient care.