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  1. Economic Impact Analyses of FDA Regulations

Importation of Prescription Drugs (Proposed Rule) Regulatory Impact Analysis

The proposed rule, if finalized, would allow commercial importation of certain prescription drugs from Canada through time-limited programs, Section 804 Importation Programs or SIPs, sponsored by at least one non-federal government entity with possible co-sponsorship by a wholesaler or pharmacist. 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 drugs that may be imported under the SIPs or the savings to U.S. consumers who may participate in such programs. 

Costs of the proposed rule may fall on the federal government, importation program sponsors, importers, and manufacturers of imported drugs. The federal government would incur costs to implement the proposed rule and conduct oversight of authorized programs. Sponsors would face costs to prepare proposals, implement approved programs, and produce program reports and records. If their drugs are imported into the U.S. from Canada, drug manufacturers may 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 drug 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 drugs and pass some of these savings to consumers, it is possible that U.S. drug manufacturers may experience a transfer in U.S. sales revenues to these parties.

Regulatory Impact Analysis

Importation of Prescription Drugs (Proposed Rule) (PDF - 337KB)

Federal Register: 84 FR 70796 - December 23, 2019

Docket: FDA-2019-N-5711

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