[1]See Ouellette v. Mills, 91 F. Supp. 3d 1 (D. Me. 2015) (striking down Maine’s earlier importation law).[2]See 21 USC 384.[3] 21 USC 384(l).

2257 (2003).[v] 21 U.S.C. § 384(a)(3).[vi] 21 U.S.C. § 384(d)(1)(K).

Given widespread public support for drug importation, this is an important area to watch. Even if HHS and FDA decide not to expand their approach to drug importation right now, the debate over personal importation likely is just getting started.I. Overview of Executive Order 13938Executive Order 13938 states as follows:The Secretary of Health and Human Services shall, as appropriate and consistent with applicable law, take action to expand safe access to lower-cost imported prescription drugs by:facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, provided such importation poses no additional risk to public safety and results in lower costs to American patients, pursuant to section 804(j)(2) of the [FDCA], 21 U.S.C. 384(j)(2);authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care pursuant to section 801(d) of the FDCA, 21 U.S.C. 381(d); andcompleting the rulemaking process regarding the proposed rule to implement section 804(b) through (h) of the FDCA, 21 U.S.C. 384(b) through (h), to allow importation of certain prescription drugs from Canada.The Legality of the Directives Regarding Individual and State Importation Is QuestionableThe first and third directives—regarding individual importation and State importation, respectively—are predicated on Section 804 of the FDCA being in effect.

The first directive of the executive order is aimed at speeding up this process, as well as expanding its scope.The executive order’s provisions relating to individual waivers and insulin largely appear to be reiterations of existing law. The executive order, however, also imposes an additional requirement, not required under 21 U.S.C. § 384(j)(2), that the imported drug not only be safe, but also result in lower costs to American patients. The insulin provision, which authorizes re-importation upon an HHS finding of its need for emergency medical care, reflects the same standard for insulin re-importation that already exists under 21 U.S.C. § 381(d)(2).Generally, drug importation policies, such as the three outlined in the executive order, face obstacles in implementation.

Increasing Drug Importation to Lower Prices for American PatientsThis Executive Order, available here, addresses the Administration’s “goal of safe importation of prescription drugs” and has three components.First, it contemplates the Secretary of HHS “facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs” provided that it “poses no additional risk to public safety and results in lower costs to the American People” under section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 384(j)(2).Second, it addresses authorizing the reimportation of insulin products where the Secretary of HHS finds that it is “required for emergency medical care” under section 801(d) of the FDCA (21 U.S.C. § 381(d)). Unless this exception is met, this statutory provision generally places limitations on the reimportation of U.S.-made insulin products.

Once FDA has authorized a SIP, Section 804 of the FDCA requires Importers to provide documentation to FDA demonstrating that “each batch of the prescription drug in the shipment was statistically sampled and tested for authenticity and degradation.” See 21 U.S.C. § 384(d)(1)(J). Under the Proposed Rule, Importers can meet that requirement by (1) requesting that the manufacturer agree to conduct the necessary testing, or (2) conducting the testing themselves, after the manufacturer provides the requisite information.

In this Bulletin, AGG will give a general overview of SIP requirements, provide some further detail surrounding Florida’s approved SIP, and offer our observations on this development.What Is the SIP Pathway?Section 804 (21 U.S.C. 384) of the Federal Food, Drug, and Cosmetic Act provides a pathway for states and Indian tribes to allow importation of “eligible prescription drugs” from Canada.Programs under this pathway must significantly reduce the cost of these drugs to the American consumer, without imposing additional risk to public health and safety.An “eligible prescription drug” is defined, in part, as: “[A] drug subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act that has been approved and has received a Notice of Compliance and a Drug Identification Number (DIN) from the Health Products and Food Branch of Health Canada (HPFB) and, but for the fact that 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,

Canadian drugs. Accordingly, Florida still has a long way to go before importing any Canadian drugs, and litigation and other actions taken by certain stakeholders will likely further complicate, delay, and possibly even prevent such importation for the longer-term.Pre-Import RequestBefore Florida can import any Canadian drugs, FDA would need to grant for each drug that would be imported under Florida’s proposal a Pre-Import Request that must be submitted by the Importer. The requirements for the Pre-Import Request are almost as lengthy as the requirements for the SIP proposal itself. For each drug product proposed for import, the Pre-Import Request requires submission of vast amounts of detailed information, including the following:Statutory Testing. Statutory Testing must be conducted by the manufacturer or Importer for each drug to test for authenticity, degradation, and to ensure that the eligible prescription drugs are in compliance with established specifications and standards. 21 USC 384(e)(1). For each drug, a Statutory Testing plan must include: (A) a description of the sampling plan for testing each shipment; (B) the name and location of the qualifying U.S. laboratory that will conduct the testing; and (C) a description of the testing method(s) that will be used. See 21 CFR 251.5(c)(4)(xi).Basis of expiration date. A complete description of how the expiration date for the relabeled drug was determined using the manufacturer’s stability studies “in accordance with the FDA-approved NDA or ANDA.” 21 CFR 251.5(c)(4)(viii).Attestations. Within 30 days of receiving the importer’s request, the manufacturer must provide detailed attestations and information to establish that the drug proposed for import meets the same conditions in the FDA-approved NDA or ANDA, other than the (Health Canada approved) labeling, including confirmation that the Canadian drug was manufactured in accordance with the conditions described in the FDA-approved drug’s NDA or ANDA, including with regard to

[1] Seehttps://www.fda.gov/media/158659/download.[2] The Final Rule was issued in 2022 to implement 21 U.S.C. § 384(b), relating to the importation of certain drugs from Canada. See also 21 C.F.R. Parts 1 and 251; 85 Fed. Reg. 62094 (Oct. 1, 2020).

Section 804 is effective, however, only if the HHS Secretary certifies to Congress “that the implementation of this section will—(A) pose no additional risk to the public’s health and safety; and (B) result in a significant reduction in the cost of covered products to the American consumer”. See Section 804 of the FDCA, 21 U.S.C. § 384(l)(1). Plaintiffs allege that the HHS Secretary Alex Azar made no conclusory statements as to safety and cost savings of the Final Rule, and therefore Azar’s certification contradicts Section 804.