Opioids

Four long overdue Medicaid guidance documents meant to help states tackle the nation’s opioid crisis are still missing, months after CMS and HHS officials promised the House Energy & Commerce health subcommittee in early March they’d get the guidance out sometime this spring.

FDA and the National Telecommunications and Information Administration on Monday (June 8) launched a 120-day pilot program under which FDA will work with internet registries to flag and take action against any website that sells unapproved opioids online.

A federal committee tasked with coordinating government actions on substance use disorders met for the first time Friday (Feb. 28) and heard presentations from various government agencies on what they are doing to tackle the nation’s drug overdose crisis.

In March, FDA’s newly established Controlled Substances Program will launch its Opioid Data Warehouse, which will allow the agency to integrate diverse data sources and enhance data analysis to pinpoint trends and new developments in the opioid crisis, FDA Deputy Center Director for Regulatory Programs Doug Throckmorton said Wednesday (Feb. 12).

A leading telehealth company and health plans suggest closing the gap on access to mental and behavioral health services is a top priority for virtual care in 2020 as they continue to adjust telehealth services to consumers’ needs and push lawmakers to pass legislation expanding access to such services.

The House Oversight & Reform Committee is already probing the Trump administration’s national drug strategy that was released Monday (Feb. 4), continuing the work of the late Chair Elijah Cummings (D-MD) who last year questioned the White House Office of National Drug Control Policy (ONDCP) on what he called an inadequate strategy.

Advocates for non-opioid pain management alternatives are calling on policymakers to increase access to non-opioid pain management alternatives, including unbundling certain drugs in outpatient settings and increasing provider training.

A panel of FDA advisors were split on whether FDA should approve Durect Corporation’s Posimir (SABER-bupivacaine extended-release solution) for post-surgical pain relief, touted by the company as a drug that would reduce use of opioids for at least 24 hours after surgery.

Members of two FDA advisory committees unanimously voted 27-0 against approving Nektar Therapeutics’ oxycodegol opioid for management of chronic low back pain. During the joint committee meeting on Tuesday (Jan. 14), advisors took issue with the lack of efficacy data for broader patient populations, and they were especially disappointed that the sponsor had only conducted one phase III efficacy study.