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MEDS Act Introduced by Collins, Smith Increases FDA Authority, Strengthens Manufacturer Reporting Requirements
WASHINGTON, D.C. - The American Hospital Association (AHA), American Society of Anesthesiologists (ASA), American Society of Clinical Oncology (ASCO), ASHP (American Society of Health-System Pharmacists), and the Institute for Safe Medication Practices (ISMP) announced their strong support for the Mitigating Emergency Drug Shortages (MEDS) Act, introduced today by Senators Susan Collins (R-ME) and Tina Smith (D-MN). The legislation includes key policy recommendations long supported by the five healthcare organizations, which have worked collaboratively on drug shortage prevention efforts since 2010.
Severe and critical drug shortages have become the norm for the nation’s healthcare system. Over the last several years, natural disasters, such as Hurricane Maria, quality problems, manufacturer consolidation, and other issues, have disrupted pharmaceutical manufacturing and left the U.S. healthcare system on the brink of a significant public health crisis multiple times.
There were well over 200 shortages in 2018, and that number has continued to grow in 2019.[1] Healthcare organizations, including hospitals, health systems, and clinics, often struggle to obtain medications, some of which are essential to maintain basic levels of patient care, such as sodium bicarbonate and IV immunoglobulin.
The MEDS Act provides increased authority for 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 our patients and the healthcare system.
The five organizations jointly convened a summit on drug shortages in November 2010 and worked together to build support for drug shortage provisions included in the 2012 FDA Safety and Innovation Act (FDASIA). Most recently, the groups hosted a summit, “Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Health Care Critical Infrastructure,” resulting in 19 recommendations, including the following, which are included in the MEDS Act:
“Over the past decade, America’s hospitals and health systems have experienced far too frequent shortages of widely used drugs that are absolutely crucial to patient care and public health,” said AHA Executive Vice President Tom Nickels. “The AHA thanks Senators Susan Collins and Tina Smith for their bipartisan commitment to tackling the issue of drug shortages by introducing today’s legislation. We look forward to working with Congress to advance the MEDS Act, which will help prevent, mitigate and resolve drug shortages and secure the supply of these life-saving products for patients and the hospitals and health systems that proudly care for them.”
“ASA is proud to endorse this important legislation that will help ensure critical drugs are available for procedures so physician anesthesiologists can provide patients safe, timely care,” said ASA President Linda J. Mason, M.D., FASA. “As leaders in patient safety, it is critical that the MEDS Act advance in Congress to decrease the risks of drug shortages and the impact on patient care. We applaud Senators Collins and Smith for their leadership on this legislation and encourage Congress to continue exploring ways to address this patient safety risk.”
“In oncology, there are often no replacements or work-arounds for therapies shown to improve survival,” said ASCO President Howard A. “Skip” Burris III, MD, FACP, FASCO. “We support this legislation, which gives the FDA greater authority to prevent or mitigate shortages before they even begin.”
“The ongoing shortages of vital, life-saving medications dangerously interfere with patient care,” said ASHP CEO Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP. “ASHP strongly supports the MEDS Act. We believe this legislation is a significant step in addressing our nation’s drug shortage crisis, and supports our goal of ensuring patients have reliable access to the medications they need, when they need them.”
About the AHA
The AHA is a not-for-profit association of health care provider organizations and individuals that are committed to the improvement of health in their communities. The AHA is the national advocate for its members, which include nearly 5,000 hospitals, health care systems, networks and other providers of care and 43,000 individual members. Founded in 1898, the AHA provides education for health care leaders and is a source of information on health care issues and trends. For more information, visit www.aha.org.
About ASA
Founded in 1905, the American Society of Anesthesiologists (ASA) is an educational, research and scientific society with more than 52,000 members organized to raise and maintain the standards of the medical practice of anesthesiology. ASA is committed to ensuring physician anesthesiologists evaluate and supervise the medical care of patients before, during and after surgery to provide the highest quality and safest care every patient deserves. For more information on the field of anesthesiology, visit the American Society of Anesthesiologists online at asahq.org. To learn more about the role physician anesthesiologists play in ensuring patient safety, visit asahq.org/WhenSecondsCount. Like ASA on Facebook; follow ASALifeline on Twitter.
About ASCO
Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO represents nearly 45,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO’s Conquer Cancer Foundation supports the Society by funding groundbreaking research and education across cancer’s full continuum. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, and YouTube.
About ASHP
ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s nearly 50,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety. For more information about the wide array of ASHP activities and the many ways in which pharmacists advance healthcare, visit ASHP’s website, www.ashp.org, or its consumer website, www.SafeMedication.com.
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[1] See American Society of Health-System Pharmacists, "National Drug Shortages: Active Drug Shortages by Quarter," available at https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics.
