FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

USP Issues Action Plan for Promoting Generics

Feb. 12, 2019

In an effort to help boost generic competition and lower drug prices, the US Pharmacopeia released a generics action plan that offers new and revised quality standards and coordinates with FDA initiatives.

Under the plan, the USP will update and develop quality standards to support the priorities of the FDA’s Drug Competition Action Plan (DCAP), including the agency’s list of off-patent, off-exclusivity branded drugs that lack generic versions.

“As part of our work to support FDA’s efforts to improve access in the marketplace where competition is limited, USP has mapped the FDA DCAP list to our monograph development work and is actively engaging with members of the public health community,” the non-profit said.

The plan prioritizes development of new quality standards for medicines used to treat hypertension, seizure disorders, cancer and HIV. It also plans to improve generics production around the world by training and educating manufacturers on best practices for applying quality standards, such as through its USP Hyderabad Training Institute and USP-APEC Center of Excellence programs.

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