[20210211]IF11056_处方药进口.pdf

https:/crsreports.congress.gov Updated February 11, 2021Prescription Drug ImportationIn the context of rising drug prices, the possibility of importing prescription drugs from other countries at lower prices is again being debated. Generally, the importation or reimportation of a prescription drug that does not meet Food and Drug Administration (FDA) requirements is prohibited. The policy debate has centered on creating a new legal option for the import of prescription drugs into the United States at lower cost than the same drugs available domestically. Prescription Drug Regulation FDA, under the Federal Food, Drug, and Cosmetic Act (FFDCA), regulates prescription drugs. In order to market a new drug in the United States, a manufacturer must obtain approval from FDA by submitting a new drug application (NDA), or in the case of a generic drug, an abbreviated NDA (ANDA). To get approval, the manufacturer must (1) demonstrate the drugs safety and effectiveness according to criteria specified in law and regulation, (2) ensure that its manufacturing facility passes FDA inspection, and (3) obtain approval for the drugs labeling. Drugs made in foreign countries that are imported into th