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1 1 (November 21, 2019)

handle is hein.crs/govbbqs0001 and id is 1 raw text is: -' .r~ ......... 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 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 and meets other specified requirements. Fac,,ilitkky i',ns\pe ctZion Domestic facilities that engage in the manufacture, preparation, propagation, compounding or processing of a drug, and foreign facilities that engage in the manufacture, preparation, propagation, compounding or processing of a drug that is imported into the United States, whether an API or the finished form of the drug, must register with FDA (FFDCA Section 510) and are subject to FDA inspection. FDA conducts preapproval, surveillance, and for-cause Updated November 21, 2019 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 the public about a drug or concerns about its quality. FDA is required to conduct surveillance inspections of both domestic and foreign establishments using a risk-based approach (FFDCA Section 510(h)). Many prescription drugs that are sold in the United States are manufactured, at least in part, abroad. FDA estimates that in 2018, 88% of facilities making APIs and 63% of sites making finished drugs were located overseas. FDA has foreign offices around the world and the agency 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. mportadkion- That ks 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 Sections 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 of Health and Human Services (HHS) pursuant to a drug shortage, and (2) pursuant to the authority at FFDCA Section 804, both of which are discussed in the next , yg\\ y gmm, Ngm 100 ILI

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