Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

ABSTRACT:

Objectives

To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world.

Design

Observational study.

Setting

Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017.

Study cohort

Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions.

Main outcome measures

Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada

SUBMITTER: Gupta R 

PROVIDER: S-EPMC5858606 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature