July 12, 2017

Senator Hassan Statement on House Passing Her Bipartisan Abuse-Deterrent Legislation as Part of FDA User Fee Bill

WASHINGTON -  Today, the U.S. House of Representatives passed the Opioid Addiction Risk Transparency Act, bipartisan legislation authored by Senator Maggie Hassan (D-NH) that will help to combat the opioid crisis. The Act was included in legislation related to the Food and Drug Administration's (FDA) user fee program.  

Research has shown that many health care providers mistakenly believe “abuse-deterrent” opioids are less addictive than other opioids, which contain the same addictive ingredients as non-abuse-deterrent opioids. "Abuse-deterrent" actually refers to technologies used in opioid drugs that target known or expected methods of abuse, such as crushing in order to snort or dissolving in order to inject. The Opioid Addiction Risk Transparency Act, which Hassan introduced with Senator Todd Young (R-IN), will help ensure that health care providers understand the addiction risks of "abuse-deterrent" opioids so that they can communicate these risks to patients.

"The substance misuse crisis is the most pressing public health and safety challenge facing New Hampshire, and we must do more to address this epidemic,” Senator Hassan said. “I am encouraged that the House included the bipartisan Opioid Addiction Risk Transparency Act in its version of the FDA user fee bill, which will be a good step to help ensure that prescribers are aware of the addiction risk of abuse-deterrent opioids. I will continue working with members of both parties to implement a comprehensive approach to the substance misuse crisis so that we can stem the tide of this epidemic and save lives.”

In addition to its inclusion in the bill passed by the House today, the Opioid Addiction Risk Transparency Act was included in the FDA Reauthorization Act approved by the Senate Health, Education, Labor and Pensions (HELP) Committee earlier this year.

Opioid products with abuse-deterrent properties 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. The Opioid Addiction Risk Transparency Act  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.