At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part plan to allow foreign prescription drugs to be imported into the United States in an effort to reduce drug prices.

The first pathway (Pathway One) for prescription drug importation is being implemented under a statutory provision in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that has been in place since 2003 – Section 804 of the FD&C Act, which is codified at 21 U.S.C. § 384.

However, no previous HHS Secretary has been willing to certify, as required by the law, that drug importation would “pose no additional risk to the public’s health and safety” and would “result in a significant reduction in the cost of covered products to the American consumer.” (And although such a certification has not yet been provided to Congress, HHS indicates that it will take that step if and when the new proposed rule is finalized.)

Because of that existing law, FDA refers to the proposed programs that may be authorized by the agency as “Section 804 Importation Programs.” In a press conference before the release of the two documents on December 18th, Secretary Azar indicated that states such as Colorado, Florida, Maine, New Hampshire, Vermont, and Michigan have expressed interest in setting up their own importation programs.

We know that Florida submitted a plan to HHS in August 2019 even before the federal government had made any detailed proposals under Section 804. Colorado expects to submit its plan to HHS by January 15, 2020, and, under a state law, Maine has until May 1, 2020, to submit its importation plan for federal review.

FDA released the Notice of Proposed Rulemaking (NPRM) for Pathway One in order authorize imports of eligible prescription drugs from Canada on December 18, 2019, as noted above. The proposed rule would create a new Part 251 in Title 21 of the Code of Federal Regulations (CFR) pursuant to the authorities available in Section 804 of the FD&C Act.

Accordingly, some of the requirements included in the NPRM come directly from the language of the statute, while others are being proposed pursuant to the discretion granted to the HHS Secretary to require any other elements in a foreign importation plan as he deems necessary to protect the public health.

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