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1 1 (December 21, 2018)

handle is hein.crs/govywz0001 and id is 1 raw text is: Congressional Research Service Informing the legislative debate since 1914 December 21, 2018 Prescription Drug Importation In 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 largely has been around creating a new legal option for the import of prescription drugs into the United States at lower cost than the same drugs available domestically. This has raised concern from stakeholders about drug safety and the feasibility of such a program. 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 first must obtain approval from FDA. To get that approval, the manufacturer must (1) demonstrate the drug's 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 drug's labeling. Pre-Market Approval FDA's prescription drug approval requirements apply to all manufacturers that market drugs in the United States, regardless of whether the manufacturing facility is located domestically or in a foreign country. Thus, before a drug manufactured in a foreign country is imported into the United States for commercial use, it must be approved by FDA. To obtain approval, the manufacturer must submit a New Drug Application (NDA), or in the case of a generic drug, an abbreviated NDA (ANDA), which must include, among other things, information about the facility in which it was manufactured, a product description (e.g., chemical formulation), processing methods, manufacturing controls, and labeling. An active pharmaceutical ingredient (API) is defined as any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug (21 CFR §203.3(e)). An API may be imported into the United States if it is the subject of a valid NDA or investigational new drug application (IND) if it is to be used for laboratory research or clinical trials. Facility Inspection Facilities that engage in the manufacture, preparation, propagation, compounding or processing of a drug, whether an API or the finished form of the drug, must register with FDA, to be inspected by the agency prior to approval. FDA conducts preapproval, surveillance, and for- cause inspections. Preapproval inspections are part of the drug approval process, while surveillance inspections are conducted once a drug is on the market to assess compliance with manufacturing standards. For-cause inspections are to investigate, for example, complaints from patients and health care professionals about a product or concerns about product quality. FFDCA Section 5 10(h) requires FDA to conduct surveillance inspections of both domestic and foreign establishments using a risk-based approach. Many prescription drugs that are sold in the United States are manufactured, at least in part, abroad. According to a December 2016 U.S. Government Accountability Office (GAO) report, FDA estimates that more than 40% of finished drugs and 80% of APIs are produced overseas. FDA has foreign offices around the world and according to a December 2016 GAO report, FDA has increased the number of foreign drug inspections conducted each year since 2009. FDA also recognizes inspections conducted by certain foreign regulatory authorities within the European Union and relies upon their inspection data. Prescription Drug Importation Foreign-made versions of FDA-approved drugs that have not been evaluated through the FDA process are typically considered unapproved new drugs and are illegal. The FFDCA provides for the circumstances under which an unapproved drug may be imported into the United States. This section discusses the circumstances under which importation is prohibited, as well as the circumstances under which it is allowed. Importation that Is Prohibited Under Current Law Under current law, the importation of unapproved new drugs, including foreign-made versions of FDA-approved drugs, is generally prohibited. This would entail bringing into the United States an unapproved drug manufactured outside of the United States. Even in cases where the drug is a foreign-made version of an FDA-approved drug (i.e., the same active ingredient made by the same manufacturer), FDA has stated that it is highly unlikely that the version for the foreign market would meet all of the requirements in the FFDCA for approval. FFDCA Section 505(a) and 301(d) prohibit the introduction of an unapproved drug into interstate commerce, and FFDCA Section 301(a) prohibits the introduction into interstate commerce of a drug that is adulterated (e.g., held under insanitary conditions) or misbranded (e.g., the labeling does not include adequate directions for use). Commercial Use. FFDCA Section 801(d)(1)(B) explicitly prohibits the importation for commercial use of unapproved drugs manufactured outside of the United States, with two exceptions: (1) except as authorized by the Secretary pursuant to a drug shortage, and (2) pursuant to the https:I/crsreports.conc -- -q

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