Policy Options for Increasing Generic Drug Competition Through Importation

The authors evaluate the FDA’s newly formed working group on drug importation as a response to dramatic price hikes on off-patent drugs with little or no generic competition, such as pyrimethamine (Daraprim). They argue that since the U.S. already imports 40% of finished pharmaceuticals and 80% of active ingredients from abroad, safety concerns about importation are manageable, and that the working group should expand its scope beyond single-source drugs to all off-patent drugs with three or fewer US manufacturers. They advocate for a system of reciprocal approval with trusted foreign regulators and harmonized bioequivalence standards to create permanent, competitive importation channels rather than temporary fixes.