In mid-March, in the span of eight days, we saw the fruition of three federal initiatives that, collectively, will drastically affect the way that pain is managed in the United States—and that will also be a positive measure to address our nation’s opioid crisis. From a policy perspective, we believe this is the tip of the iceberg, and we expect to see much legislation and regulation related to these initiatives.
1. On March 15, 2016, the US Centers for Disease Control and Prevention (CDC) released its Guideline for Prescribing Opioids for Chronic Pain in primary care settings. You can read the American Academy of Pain Management’s response to the guideline here.
2. On March 18, 2016, the National Pain Strategy was released by the Department of Health and Human Services. We have long awaited the release of the NPS, and we, along with the Consumer Pain Advocacy Task Force, are actively supporting its implementation. Look for a sign-on opportunity coming your way very soon.
3. On March 22, 2016, the U.S. Food and Drug Administration announced that it will now require enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death; and further, that the indication for IR opioids will now state that the medications should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated. Just two days later, the FDA issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.