Healthcare Update

FDA Announces Final Rule Addressing Importation of Certain Prescription Drugs From Canada

September 29, 2020

The U.S. Food and Drug Administration (FDA) has published a final rule establishing a legal framework for the importation of certain prescription drugs from Canada. See Importation of Prescription Drugs, Final Rule (Sept. 24, 2020) (“Final Rule”). The final rule permits states, American Indian tribes, and, in some circumstances, pharmacists and wholesale distributors to submit importation plans to FDA for review and authorization to import certain prescription drugs from Canada. For such plans to be approved, sponsors will have to show that importation of any particular drug would “pose no additional risk to the public’s health and safety” and “result in a significant reduction in the cost of covered products to the American consumer,” 21 U.S.C. § 384(l). The rule is expected to publish in the Federal Register on Thursday, October 1, 2020, and go into effect 60 days after publication.

The proposed rule was published on December 23, 2019, and received over 1,200 public comments. The final rule comes in the wake of Executive Order No. 13938, which required the Secretary of Health and Human Services to finalize the rulemaking for prescription drug importation from Canada as well as the reimportation of insulin products “required for emergency medical care” and waivers to individuals of the prohibition on prescription drug importation. See Exec. Order No. 13938, Increasing Drug Importation to Lower Prices for American Patients (Jul. 24, 2020).

The final rule permits the importation of an “eligible prescription drug,” which the rule defines as a drug that both is approved by the Canadian Health Products and Food Branch (HFPB), and “but for the fact it deviates from the required U.S. labeling, also meets the conditions in an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA) for a drug that is currently commercially marketed in the United States, including those relating to the drug substance, drug product, production process, quality controls, equipment, and facilities.” Final Rule at 122 (to be codified at 21 C.F.R. § 251.2). The final rule further excludes the importation of controlled substances; biological products; infused drugs; intravenously, intrathecally, or intraocularly administered drug; drugs that are inhaled during surgery, risk evaluation and mitigation strategy drugs; and drugs that are not considered products for purposes of the Federal Food, Drug, and Cosmetic Act (FDCA) section 582. Id. at 123 (to be codified at 21 C.F.R. § 251.2).

Under the final rule, manufacturers must provide Section 804 Importation Program (SIP) sponsors with sufficient information to demonstrate whether a drug is equivalent to an FDA approved drug. In particular, the manufacturer must either test the imported drugs for authenticity, degradation, and compliance with the applicable NDA or ANDA or must provide the SIP sponsors with the information and data necessary for a third-party laboratory to perform the required testing. Id. at 128, 162–62 (to be codified at 21 C.F.R. §§ 251.2, 251.16(b), (e)). The manufacturer also must provide, upon request, an attestation and information statement establishing that “the drug proposed for import, but for the fact that it bears the HPFB-approved labeling, meets the conditions in the FDA-approved NDA or ANDA, including any process-related or other requirements for which compliance cannot be established through laboratory testing.” Id. at 141 (to be codified at 21 C.F.R. § 251.5(c)(4)(xii)). Finally, the manufacturer must authorize the SIP sponsor to use the drug’s FDA approved labeling at no cost. Id. at 150 (to be codified at 21 C.F.R. § 251.13(a)). The preamble to the final rule states that a manufacturer that fails or refuses to comply with these obligations can face a civil enforcement action or criminal sanctions. Id. at 36–37.

A SIP sponsor that wishes to import prescription drugs must submit an application to FDA that specifies the eligible prescription drug for importation, as well as identify the foreign seller and importer. Id. at 5 (to be codified at 21 C.F.R. § 251.3). The final rule states that FDA “may authorize a SIP, modify a SIP, or extend the authorization period of a SIP” that meets the requirements of the rule, but does not assign a timeframe for review. See id. at 137–38 (to be codified at 21 C.F.R. § 251.4). The agency may also deny a request for authorization of a SIP for several reasons, including if it does not meet requirements of the rule because of “potential safety concerns with the SIP” or based on the “relative likelihood that the SIP proposal or supplemental proposal would not result in a significant cost savings to the American consumer.” After a SIP application is approved, the importer must relabel the eligible prescription drug upon importation from Canada with the following statement: “[This drug was/These drugs were] imported from Canada without the authorization of [Name of Applicant] under the [Name of SIP Sponsor] Section 804 Importation Program.” Id. at 7 (to be codified at 21 C.F.R. § 251.13). Finally, a SIP sponsor must provide data and information to FDA following importation, including cost savings to the American consumer. Id. at 7 (to be codified at 21 C.F.R. § 251.18).

FDA simultaneously published a final guidance on importation of prescription drugs, including biological products and combination products under section 801(d)(1)(B) of the FDCA. SeeFDA, Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry (Sept. 2020).

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