August 03, 2017

Senator Hassan’s Bipartisan Opioid Addiction Risk Transparency Act Headed to President’s Desk as Part of FDA Bill

First Bill Authored by Senator Hassan to Pass Congress Will Help Ensure Health Care Providers Understand Addiction Risks of “Abuse-Deterrent” Opioids

Senator Maggie Hassan’s bipartisan Opioid Addiction Risk Transparency Act passed the U.S. Senate today as part of the Food and Drug Administration Reauthorization Act of 2017. The legislation, which will help ensure that health care providers understand the addiction risks of “abuse-deterrent” opioids, is the first provision authored by Senator Hassan to pass both chambers of Congress and head to the President’s desk for signature.  

The FDA Reauthorization bill included the Opioid Addiction Risk Transparency Act, which was introduced by Senator Hassan and Senator Todd Young (R-IN) and takes important steps to help ensure that health care providers understand the addiction risks of “abuse-deterrent” opioids so that they can properly communicate those risks to their patients.

“As the heroin, fentanyl, and opioid crisis continues to ravage communities across New Hampshire and throughout America, it is critical that we do everything in our power to stem the tide of addiction, which we know comes in large part from the overprescribing of opioids,” Senator Hassan said. “I am pleased that the Senate voted to approve this bill to help ensure that providers and patients are aware of the addiction risks of so-called abuse-deterrent opioids, and I urge President Trump to sign this bill as quickly as possible.”

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. In fact, one survey showed that 46 percent of primary care providers think that abuse-deterrent products are less addictive than other opioids. 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.