fbpx Skip to main content

BioCommunique Article

Please share your concerns regarding importation and how it affects business with our public policy team by January 31st.

Opportunity to Provide Feedback on FDA’s Importation Plan

  • 2020-01-17T19:00:00.000+0000
  • Washington DC
  • Author: Brittany Blocker

In late December, the United States Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued two documents, a notice of proposed rulemaking (NPRM) and a draft guidance, intended to establish two pathways for drug importation. HHS previewed these approaches in July 2019 in its Safe Importation Action Plan. The NPRM would allow for the importation of certain prescription drugs from Canada. The draft guidance outlines procedures drug manufacturers would follow to help facilitate the importation of prescription drugs, including biologics that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in the foreign country.

Importation is a top priority for Biocom and we intend to submit comments to share our concerns. We are seeking feedback from members on both the NPRM and the draft guidance. Please email your comments to Biocom’s Manager of Regulatory Affairs, Brittany Blocker, at bblocker@biocom.org by January 31st.

Biocom’s initial concerns are:

  • The NPRM fails to meet a substantive condition necessary for implementation set out in the statue. The proposed rule does not establish a factual predicate for the second requirement “result in a significant reduction the cost of covered products to the American consumer.”
  • Importation undermines the track and trace system established by the Drug Supply Chain Security Act (DSCSA). Products sold for the Canadian market lack a DSCSA-compliant standardized numerical identifier. This would break the necessary DSCSA tracking history.
  • Importation endangers patient safety by enabling counterfeits. If DSCSA standards are lowered, it will be difficult to separate legitimate drugs from illicit drugs because imported products cannot be traced back to the original manufacturer.

Pathway I: Section 804 Importation Programs (SIP)
Under Pathway I, HHS would implement Section 804 of the Food, Drug, and Cosmetic Act (FDCA), which gives HHS the authority to create time-limited projects to import prescription drugs from abroad. The NPRM proposes to allow states or certain non-federal governmental entities and their co-sponsors, if any, to apply to create SIPs to import drugs from Canada. A SIP could be co-sponsored by a pharmacist, a wholesaler, or another state or non-federal governmental entity. The SIPs would need to show that their programs would (1) not compromise patient safety and (2) result in a reduction in cost of covered products.

Under the proposed rule, the SIP proposal would need to identify the foreign seller in Canada that will purchase the eligible prescription drug directly from its manufacturer, and the importer in the United States that will buy the drug directly from the foreign seller. The imported drugs would need to be approved by the Canadian Health Products and Food Branch (HPFB) and they must meet the conditions for an FDA-approved new drug application.

Drugs eligible for importation under this pathway are limited to those defined as a prescription drug under Section 804(a)(3) of the FD&C Act. This means that controlled substances, biological products, infused drugs, intravenously injected drugs, and drugs that are inhaled during surgery are excluded and would not be eligible to import under this NPRM.

Pathway II: Multi-market approved (MMA) Products Program
In addition to the NPRM, the FDA also issued a draft guidance entitled “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act,” which addresses importation of multi-market approved (MMA) drugs. The draft guidance authorizes manufacturers to import their own drugs intended for sale abroad and sell them in the United States. Under this pathway, a manufacturer would market the imported version of its drug under a different NDC number than the domestic version, which might allow the manufacturer to introduce it to the U.S. market at a lower price. To be eligible for manufacturer reimportation, an MMA product must meet several criteria including that the foreign product differs from the FDA-approved product only with respect to the prescription labeling. Unlike Pathway I, Pathway 2 would include biologics, insulin, or intravenous or injectable drugs.