July 11, 2019

Manchin, Braun Introduce The FDA Opioid Labeling Accuracy Act

Washington, D.C. – U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN), today introduced the FDA Opioid Labeling Accuracy Act, which would prohibit the Food and Drug Administration (FDA) from allowing opioids to be labeled for intended use of “around-the clock, long-term opioid treatment” until a study can be completed on the long-term usage of opioids.

“In the United States, we consume 80 percent of the world’s opioid production and in 2017, one single year, over 70,000 people died due to drug overdoses. These statistics are unacceptable. As one of the hardest hit states, West Virginia has been on the front lines of the opioid epidemic, which is why I have introduced this bill today with Senator Braun to address how the FDA approves opioid prescriptions for treating different types of pain. Addressing the opioid epidemic has always been my top priority and I will continue to fight for legislation that helps West Virginians and our country fight this epidemic and I look forward to working with my colleagues on both sides of the aisle to pass this bill,” said Senator Manchin.

“We lose three Hoosiers a day to opioid overdose, and this crisis begins at the prescription pad.  Addressing this epidemic shouldn’t be a partisan issue, and I’m glad to team up with Senator Manchin to reform how FDA approves and labels opioid drugs to protect Hoosier patients,” said Senator Braun.

In 2001, the FDA updated opioid labels to indicate use from “moderate to severe pain where use of an opioid painkiller is used for more than a few days” to “management of moderate to severe pain when opioids are needed for an extended period of time.” With this change, opioids began to be prescribed as a first line of treatment for long-term chronic pain that surpassed the original intended use for cancer pain or short term post-surgical pain and definitively contributing to the heightening of the opioid epidemic.

The FDA Opioid Labeling Accuracy Act would prohibit opioids from being labeled for intended use to treat long-term chronic pain, except for cancer pain, end-of-life care or when a prescriber has determined that all non-opioid treatments are inadequate or inappropriate. This bill would address over-prescribing of opioids for long-term chronic pain until a complete study can be performed to determine the effectiveness of opioids for long-term non-cancer or end-of-life pain management. This study will then be used by the FDA to reevaluate and update opioid labels to reflect the results of the study.

To view the full bill text click here.