Senator Questions FDA Commissioner on Implementation of Bipartisan Opioid Addiction Risk Transparency Act
Senator Also Presses Agency Leaders on the Need for More Federal Resources to Address the Opioid Crisis
See here for a video of the hearing.
WASHINGTON – Senator Maggie Hassan participated today in a Health, Education, Labor, and Pensions (HELP) Committee hearing on the federal response to the heroin, fentanyl, and opioid crisis. Senator Hassan questioned Food and Drug Administration (FDA) Commissioner Scott Gottlieb on what steps the FDA is taking to implement the bipartisan Opioid Addiction Risk Transparency Act, legislation that Senator Hassan introduced with Senator Todd Young (R-IN) 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. The bill was signed into law as part of the FDA Reauthorization Act of 2017.
Senator Hassan asked Commissioner Gottlieb what steps the FDA has taken to use the authority provided by the Opioid Addiction Risk Transparency Act in order to make sure that doctors, and in turn patients, understand that abuse-deterrent opioids are just as addictive as other opioids.
Commissioner Gottlieb noted that the FDA is currently studying the use of the term “abuse-deterrent” to make sure that such terminology does not convey to doctors and patients that “a drug that has abuse-deterrent features is less prone to addiction because we know it’s not.” Gottlieb added, “The abuse-deterrent features on the current drugs make them less prone to manipulation that allows them to be abused in ways through inhalation and injection but they still can cause addiction. And so we’re looking at this scientifically and we should have that information back in a reasonable time frame and I’d be happy to come in and talk to you about our results.”
Senator Hassan also asked the panel of federal agency leaders “to just reflect on what it is that your agency isn’t doing right now that it could be doing or should be doing to help us combat this crisis.”
Senator Hassan added, “People ask me why we don’t have more resources than we already do, knowing how hard everybody here is working, and they do ask me the question that relates back to the stigma that you talked about Dr. McCance-Katz that, if this this were a different kind of epidemic would we have more money on the ground, would we be having a debate at all about whether we needed more resources, and I think it’s a good question… I mean, think about the courage that that takes and the courage that it takes for people to come forward to their elected officials and say ‘I’m in treatment right now,’ or, ‘I’m raising my granddaughter because my daughter died of an overdose last month.’ People have been willing to stand up and talk about this illness and they’re helping us understand it as the illness it is, but the stigma is still out there, and I hope that with every piece of energy you all have in the jobs that you have been entrusted with, you will speak to the need for us to devote resources to what is an epidemic, a disease, that will include relapse and have co-occurring problems that will challenge us moving forward.”
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