August 23, 2017

Senator Young Opioid Addiction Risk Transparency Act Signed into Law

WASHINGTON, D.C. – On August 18, 2017, President Trump signed the Food and Drug Administration Reauthorization Act of 2017 into law, which included Senator Young’s Opioid Addiction Risk Transparency Act. The legislation was authored in partnership with Senator Maggie Hassan of New Hampshire.

“A simple conversation can have the ability to make a huge difference in the opioid epidemic that is plaguing many communities in Indiana and around the country,” said Senator Todd Young. “This proposal would offer doctors better information about the risks of addiction and encourage them to communicate that information with their patients. That’s a conversation worth having.” 

The Food and Drug Administration (FDA) designates certain opioids as “abuse-deterrent” if they have properties that make it harder to abuse them in certain ways, such as making the pills harder to crush or inject. But these products can still be abused, for example, by swallowing multiple pills. And many abuse-deterrent drugs can still be tampered with to be abused in other ways, as well. Abuse-deterrent drugs contain the same addictive ingredients as opioids in other formulations; however, many health care providers are not made aware of the fact that abuse-deterrent opioids are no less addictive than opioid products without such abuse-deterrent properties. One survey showed that 46 percent of primary care providers think that abuse-deterrent products are less addictive than other opioids.

Health care providers need to know that these products are just as addictive as other opioids so that they can inform patients of these risks. The Opioid Addiction Risk Transparency Act would help address this problem by getting information to health care providers about the limitations and patient care implications of abuse-deterrent formulations. 

This bill strongly encourages the FDA to require drug manufacturers to include information about the risk of addiction from abuse-deterrent drugs in manufacturers’ communications plans to help manage known risks related to opioids as part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program.