Opioids

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.

CMS approved a waiver allowing Indiana to use Medicaid to fund inpatient treatment for serious mental illness in late December. The state joins Vermont and the District of Columbia in using Medicaid to fund inpatient treatment in certain large facilities for both serious mental illness and substance use disorder.

FDA is demanding Alkermes stop publishing a print advertisement for its extended-release naltrexone drug Vivitrol, which is used to treat opioid addiction, because the ad fails to warn fatal overdoses could occur if the treatment lapses.

CMS announced Wednesday (Nov. 6) that it approved a waiver to allow District of Columbia to sidestep a restriction on using Medicaid dollars to fund inpatient treatment for substance use and mental illness.

The Senate on Thursday (Oct. 31) passed 84-9 an FDA spending package that gives the agency $3 billion in discretionary funding, which is an $80 million increase over fiscal 2019 levels but still a far cry from the $184 million increase in the bill passed by the House in June.

Providers and hospitals applauded a rule proposed by the Substance Abuse and Mental Health Services Administration to loosen privacy protections on substance use records but still called on SAMHSA to make the scheme, known as 42 CFR Part 2, more like the less-stringent Health Insurance Portability and Accountability Act by altering parts of the proposal.

In a brief two-page report, the Government Accountability Office highlights the potential for opioid vaccines and lays out the challenges and policy questions surrounding their development, including what standards FDA should set for clinical trials and what resources would be needed.

A group of medicine and public health researchers and historians are calling on an Ohio court overseeing the national multidistrict opioid litigation to ensure that any settlement guarantees full and permanent access to records that contain information about and shed light on the abuse potential and distribution patterns of opioids.

The Certified Community Behavioral Health Clinic demonstration program lost its funding Friday (Sept. 13) for the second time this year after a short-term extension lapsed, threatening access to medication-assisted treatment and the jobs of those who work at these clinics, according to patient advocates.