Opioids

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safety and effectiveness to already-approved analgesics when making future approval decisions, the agency revealed in a draft guidance published Thursday (June 20).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).

The White House Council of Economic Advisers says falling out-of-pocket prices for opioids could explain between 31% and 83% of the growth in opioid overdose deaths between 2001 and 2010, and the council’s report tied that drop in costs to more government subsidization of the drugs through Medicare Part D and the entry of generics in the market.

FDA launched an educational campaign to help consumers understand how to dispose of unused opioid medications in their homes.

FDA is requiring changes to the prescribing information for all opioid analgesic medicines used in the outpatient setting to provide more information about how health care providers can safely decrease the dose in patients who are physically dependent on opioids, the agency announced Tuesday (April 9).

Reps. Markwayne Mullin (R-OK) and Earl Blumenauer (D-OR) reintroduced anticipated bipartisan legislation Wednesday (April 3) that would 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).