Opioids

The White House Office of National Drug Control Policy issued advisories that explain how pharmaceutical and chemical supply companies can identify illicit fentanyl manufacturing and redistribution and prevent movement of fentanyl and other synthetic opioids into and within the United States.

FDA’s pediatric advisory committee will meet late next month to discuss the safety of opioids to manage pain in children, and to share the results of a study on the neuropsychiatric effects of an asthma drug called montelukast, more commonly known as Singulair.

State Medicaid programs soon will be required to implement stricter controls around opioid prescriptions and will also gain the option to more easily access federal money to care for beneficiaries with substance use disorders in large inpatient treatment centers.

The National Association of Attorneys General called on House and Senate leaders to vote on bills that would loosen the strict privacy scheme known as 42 CFR Part 2, pass legislation to remove barriers to accessing buprenorphine, and fully eliminate the Institutions for Mental Diseases (IMD) exclusion in order to expand access to medication-assisted treatment (MAT).

FDA is expediting review of all generic drug applications for overdose-reversal drugs, including naloxone nasal spray, injection and auto-injector, and nalmefene injection, the agency announced Monday (July 8).

Providers and plans are optimistic that legislation to align the strict privacy scheme for substance abuse treatment records, 42 CFR Part 2, with the less-stringent Health Insurance Portability and Accountability Act (HIPAA) have a better chance of success after the American Medical Association opted to throw its support behind amending the privacy scheme and support from lawmakers has increased.

FDA will take into account a proposed opioid’s broader public health effects, including on non-users, and look at how the product compares in safety and effectiveness to already-approved analgesics when making future approval decisions, the agency revealed in a draft guidance published Thursday (June 20).

CMS Administrator Seema Verma and senior advisor to the president Kellyanne Conway touted efforts by CMS and the Trump administration to improve maternal health in rural areas by extending Medicaid coverage for postpartum women with substance use disorders, but advocates said Medicaid coverage should be extended for all postpartum women and more states should expand Medicaid, speaking at a Kaiser Family Foundation event Wednesday (June 12).

States can receive additional federal funding to extend the duration of some Medicaid health homes designed to treat people with substance use disorders, CMS said Tuesday (May 7).