USA – Unified agenda: FDA publishes lengthy to-do list

Two final rules top the Spring 2020 regulatory agenda for the US Food and Drug Administration (FDA), addressing the importation of prescription drugs and the de novo classification process for medical devices. The agency’s unified agenda overall is mammoth and includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.

The importation of prescription drugs continues to be among deregulatory priorities for the Trump Administration. This Spring’s agenda notes that FDA aims to publish a final rule by December 2020, after publishing a Notice of Proposed Rulemaking (NPRM) last December.

If finalized, the rule would allow states and certain other non-federal government entities to seek FDA authorization to import certain prescription medicines from Canada. Such programs could be sponsored by a pharmacist, pharmaceutical wholesaler or a state or government below the federal level, according to the proposed rule. Certain products would be excluded, including insulins, controlled substances, intravenous drugs, drugs with Risk Evaluation and Mitigation Strategies (REMS) and drugs injected in the spine or eye…