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  1. Economic Impact Analyses of FDA Regulations

Importation of Prescription Drugs (Final Rule) Regulatory Impact Analysis

This final rule allows commercial importation of certain prescription drugs from Canada through time-limited Section 804 Importation Programs (SIPs) sponsored by a State or Indian Tribe, and in certain circumstances by a pharmacist or wholesale distributor, with possible co-sponsorship by a State, Indian Tribe, pharmacist, or wholesale distributor. As we lack information about the expected scale or scope of such programs, we are unable to estimate how they may affect U.S. markets for prescription drugs. In particular, we are unable to estimate the volume or value of eligible prescription drugs that may be imported under the SIPs or the savings to U.S. consumers who may participate in such programs.

Costs of the final rule may fall on the federal government, SIP sponsors, importers, and manufacturers of eligible prescription drugs. The federal government will incur costs to implement the final rule and conduct oversight of authorized programs. Sponsors will face costs to prepare proposals, implement authorized programs, and produce records and program reports. Private intermediaries, such as wholesaler distributors or pharmacists, that contract with a SIP sponsor will face business expenses to implement a SIP. If their drugs are imported into the U.S. from Canada, drug manufacturers will have to provide importers with certain information. These costs depend on the number and type of participating importation programs. We lack information to estimate these costs.

Finally, U.S. patients, as well as wholesale distributors, pharmacies, hospitals, and third-party payers may all experience savings, but we lack information necessary to estimate such savings. As drug distributors realize savings in acquiring imported eligible prescription drugs and pass some of these savings to consumers and other payers, it is possible that U.S.-based drug manufacturers may experience a transfer in U.S. sales revenues to these parties.

Regulatory Impact Analysis

Importation of Prescription Drugs (PDF - 185KB)

Federal Register: 85 FR 62094, October 1, 2020

Docket: FDA-2019-N-5711

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