FDA Outlines Opioid Crisis Focus in Budget Proposal

FDA says it proposed FY 2022 budget requests an increase of $38 million above the current year’s enacted level to support CDER and CDRH activities involving the opioid crisis. In an online post, FDA acting commissioner Janet Woodcock says the agency’s work going forward will address four priority areas related to the crisis: (1) decreasing exposure and preventing new addiction; (2) supporting treatment for those with opioid use disorder; (3) helping develop novel non-opioid pain treatment therapies; and (4) improving enforcement and assessing benefit-risk.

Specifically within the drugs Center, Woodcock says the added resources would help it assess feasibility to integrate the opioid Risk Evaluation and Mitigation Strategies (REMS) education into information technology health systems/electronic health records and explore using such systems to support REMS goals, such as prescriber education.