Promising lower drug prices, the Trump administration released its long-awaited proposed rule to allow states to import drugs from Canada — and a draft guidance for drugmakers who wish to import products they currently sell overseas.
The proposed rule would allow states to come up with their own Canadian drug importation program proposals, subject to FDA approval. The programs must show “significant cost reductions” for patients from imports of prescription drugs approved by the FDA and Health Canada. The state programs could be co-sponsored by wholesalers and pharmacies.
The proposed rule does not include biological products, controlled substances, infused drugs (including peritoneal dialysis solutions), intravenously injected drugs or drugs inhaled during surgery. In addition, drugs subject to Risk Evaluation and Management Strategies, such as opioids, may not be imported.
Under the proposed rule, medicines will have to be relabeled to meet FDA requirements and tested for identity and quality.