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Ten ways the FDA is addressing the opioid epidemic


Scott Winiecki, MD, of the FDA Center for Drug Evaluation and Research, shares how the FDA is working to address the opioid epidemic.

At CBI’s Prescription Drug Monitoring Programs (PDMP) conference in Baltimore on February 7, presenter Scott Winiecki, MD, Safe Use Team lead, at the FDA Center for Drug Evaluation and Research, explained how the FDA is working to address the opioid epidemic.

“We are taking action,” said Winiecki. “Don’t think we are sitting idly by.”

Specifically, Winiecki pointed to the FDA Opioid Action Plan and Safe Use Initiative.

FDA Opioids Action Plan. The plan, announced in February 2016, is a “far-reaching” program to reassess the FDA’s approach to opioids, said Winiecki. It focuses on policies to reverse the epidemic while providing patients in pain with access to the medications they need.

FDA Safe Use Initiative. The Safe Use Initiative seeks to “reduce preventable harm” from opioid prescribing, said Winiecki. This includes reducing inappropriate use (such as a prescriber not incorporating current knowledge when a drug is selected; or not taking actions to address the avoidable subsets of identified risks, unintended exposures, and unintentional misuse). The initiative funds external research projects that develop innovative methods to reduce preventable harm.

Here are 10 more specific steps the FDA is taking to address the opioid epidemic:

1. Supporting efforts to improve/expand PDMPs. The FDA has supported the PDMP center of excellence at Brandeis University, and it is working to improve prescriber utilization of PDMPs, said Winiecki. This includes outreach efforts to understand the details of each state’s PDMP and data sharing between PDMPs (which is complex due to numerous state-based programs and approaches). Overall, the FDA seeks to identify which methods are modifying prescribing behavior in a positive way. Still, Winiecki acknowledged, “FDA is a federal agency and we don’t want to overstep our bounds. The states run their own show, and while we want to be supportive, we don’t want to interfere with that.”

2. Funding projects associated with the Safe Use Initiative. Currently, there are 15 active Safe Use Projects.

3. Expanding use of advisory committees before approving new drug applications for opioids that do not have abuse-deterrent properties. These committees seek to increase input from outside the agency, said Winiecki, noting that a common criticism against the FDA is that it is too isolated.

4. Requiring post-market safety studies aimed at getting a better sense of the long-term safety and long-term risk of opioids.

5. Reassessing the risk-benefit approval framework for opioid use. Winiecki stressed that the risk/benefit information now needs to take in the “public health” perspective of opioids. “I think that does change the bar of the risk/benefit analysis in terms of approving opioids because everyone should appreciate how serious this issue is and how prevalent this issue is,” he said.

6. Increasing the number of prescribers who participate in Risk Evaluation and Mitigation Strategy Programs.  The goal is to ensure providers receive adequate training on pain management and safe prescribing. “Education eliminates the, ‘I wasn’t aware of,’ or ‘I didn’t know,’ or ‘I trained a long time ago’ excuse,’” said Winiecki

7. Encouraging innovation in and approval of abuse-deterrent formulations. Abuse-deterrent formulations are part of the answer to addressing the epidemic, but not the answer, said Winiecki. A medication can be “abuse deterrent but it’s not abuse proof,” he said.

8. Developing label changes (warnings and safety information) for immediate release opioids.

9. Supporting better treatment, such as through exploring naloxone availability and access.

10. Taking additional actions. Warning letters regarding misleading ads, scientific workshops, public hearings, and working more closely with the national association of boards of pharmacy, are among them.

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