Hatch, Markey introduce legislation to require warning labels on Rx opioid painkillers


Senators Orrin Hatch (R-UT) and Edward J. Markey (D-MA) introduced the Lessening Addiction By Enhancing Labeling (LABEL) Opioids Act.

With more than 40 percent of all opioid overdose deaths in the United States in 2016 being linked to prescription opioids, this legislation requires prescription opioid bottles to be labeled with a consistent, clear, and concise warning that opioids may cause dependence, addiction, or overdose.

“The Controlled Substances Act already requires certain warnings to be included on opioid drug labels,” said Hatch. “This bill will make an important addition to those warnings to include the risk of dependence, addiction, or overdose.  These warnings will be a simple but important part of our broader response to the nation’s opioid crisis, spurring much-needed dialogue between doctors and patients about the potential harms of prescription opioids.”

This week, the Senate is preparing to take significant action on the opioid crisis, hoping to advance legislation that contains Senator Hatch’s legislative proposals from the Senate Finance Committee, Senate Judiciary Committee, and Senate Health, Education, Labor, and Pensions Committee all in one package. We will pass on additional updates on that proposal when they’re available.


The bill 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. The label required by this legislation will directly inform patients of the potential risks of these drugs and help spur conversations between patients and their providers about appropriate use and disposal of opioids.

Utah, Arizona, and Hawaii have passed state laws requiring labeling of prescription opioids, and legislation has been introduced in New Jersey and New York. Canada has issued regulations to require opioid labeling nationally.

The legislation is endorsed by the American Public Health Association, Massachusetts Medical Society, Trust for America’s Health, and the Community Anti-Drug Coalitions of America (CADCA).

A copy of the LABEL Opioids Act can be found HERE.