WASHINGTON, D.C. – Today, U.S. Senator Mike Braun (R-IN) and U.S. Senator Ed Markey (D-MA) will introduce two bills aimed at providing clear warnings to patients regarding the risk of opioid drugs and instituting mandatory education on responsible prescribing practices for anyone prescribing controlled substances.
The first bill, Lessening Addiction by Enhancing Labeling (LABEL) Act, would require prescription opioid bottles to be labeled with a consistent, clear, and concise warning that opioids may cause dependence, addiction, or overdose. Specifically, the legislation 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.
The second, the Safer Prescribing of Controlled Substances Act, requires that all prescribers applying for a federal license to prescribe controlled substances, such as prescription painkillers, complete mandatory education that will help encourage responsible prescribing practices.
“Last year, we lost four Hoosiers a day to drug overdose, and President Trump has secured $6 billion to combat this crisis by rightfully declaring the opioid epidemic a national emergency. These bills will provide him with two solutions to combat this crisis by requiring clear warning labels on opioid prescription bottles, as well as requiring prescribers receive mandatory education for responsible prescribing practices,” said U.S. Senator Mike Braun.
“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.”
LABEL (Lessening Addiction by Enhancing Labeling) Opioids Act—
The bill would require prescription opioid bottles to be labeled with a consistent, clear, and concise warning that opioids may cause dependence, addiction, or overdose. Specifically, the legislation 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.
Safer Prescribing of Controlled Substances Act—
The Safer Prescribing of Controlled Substances Act requires that all prescribers that are applying for a federal license to prescribe controlled substances (i.e. DEA license—which is our federal hook here, as a body of requirements already exists for prescribers who seek a DEA license), such as prescription painkillers, complete mandatory education that will help encourage responsible prescribing practices.