Senators Markey and Braun Introduce Bipartisan Legislation to Require Warning Labels on Addictive Prescription Opioid Painkillers, Mandate Education for Prescribers of Opioids


More than 47,000 Americans died of an opioid overdose in 2017, 17,000 involved prescription opioid painkillers


Washington (May 14, 2019) – Senators Edward J. Markey (D-Mass.) and Mike Braun (R-Ind.) today introduced two pieces of bipartisan legislation to help combat the opioid epidemic. The first bill, the Lessening Addiction By Enhancing Labeling (LABEL) Opioids Act, calls for labeling prescription opioid bottles with a consistent, clear, and concise warning that opioids may cause dependence, addiction, or overdose. The second piece of legislation, the Safe Prescribing of Controlled Substances Act, requires any prescriber of opioid medication to undergo mandatory education on safe prescribing practices. Specifically, it requires all prescribers that are applying for a federal license to prescribe controlled substances, such as prescription painkillers, complete mandatory education that will help encourage responsible prescribing practices.


“The path from one bottle of prescription painkillers to addiction needs as many barriers as possible,” said Senator Markey. “We need to ensure that anyone signing a prescription for opioid painkillers understands the full impact that prescription may have on the life of a patient. And then we need to put labels on those prescriptions to caution patients about the dangers of prescription opioids. Our country is drowning in too many super-charged prescription painkillers, and our families are paying the price with addiction and overdoses. We need to stop opioid abuse and addiction before it takes hold, and these two bills will help doctors and patients make responsible decisions.”


“President Trump has declared the opioid a national emergency, he has secured $6 billion in new funding to combat the opioid crisis and these two bills will provide him with two additional solutions to fixing this crisis by requiring prescription opioid bottles with a concise warning labels, while also requiring mandatory education that will help encourage responsible prescribing practices,” said Senator Braun.


Specifically, the LABEL Opioids Act would require the Food and Drug Administration (FDA) to issue regulations providing for a warning label to be affixed directly to the opioid prescription bottle handed to the patient by the pharmacist. Despite actions taken by many states and the federal government to limit opioid prescriptions and educate providers and consumers about the risks of opioids, approximately 50 percent of opioid dependence still originates with prescription painkillers. Utah, Arizona, and Hawaii have passed state laws requiring labeling of prescription opioids, and legislation has been introduced in several other states. Canada has issued regulations to require opioid labeling nationally. Congressman Greg Stanton (AZ-09) has introduced companion legislation in the House of Representatives. 


The LABEL Opioids Act is supported by the American Public Health Association, Community Anti-Drug Coalitions of America, National Association of County and City Health Officials, National Safety Council, Trust for America’s Health, and the Massachusetts Medical Society. A copy of the bill can be found HERE.


The mandatory education required by the Safe Prescribing of Controlled Substances Act would focus on best practices for pain management and alternative non-opioid therapies for pain, methods for diagnosing and treating a substance use disorder, linking patients to evidence-based treatment for substance use disorders, and tools to manage adherence and diversion of controlled substances, including Prescription Drug Monitoring Programs. The legislation also requires that the Department of Health and Human Services evaluate after how implementing this new education requirement impacts prescribing patterns. The legislation is co-sponsored by Senator Joe Manchin (D-W.V.). Congresswoman Lori Trahan (MA-03) has introduced companion legislation in the House of Representatives.


The Safe Prescribing of Controlled Substances Act is supported by the American Public Health Association, American Society of Addiction Medicine, National Council for Behavioral Health, National Safety Council, and the Massachusetts Medical Society. A copy of the bill can be found HERE.