HHS and FDA Open Notice and Comment Period for Draft Importation Rule

January 31, 2020

Topics: Patient Safety

By: Libby Baney and Matthew Rubin, Faegre Baker Daniels

Last month, we chronicled all that has occurred the past year related to prescription drug importation and implications for the cost of medicines and potential impacts on patient safety. In 2020, the Trump Administration is pushing forward on its promises to take such actions. On Monday, December 23, 2019, the United States Department of Health and Human Services (HHS) released a formal notice of the proposed rule and draft guidance for industry for comment that aligned with the Safe Importation Action Plan released by Food and Drug Administration (FDA) in July 2019.

The Trump Administration is now seeking formal comments from stakeholders around two pathways to presumed lower drug prices for consumers.

  • Pathway 1 provides states, wholesalers, pharmacists, and other nongovernmental groups with the ability to import specific drugs from Canada under section 804 of the Federal Food, Drug, and Cosmetic Act. Ultimately, Pathway 1 must also demonstrate significant cost savings for US consumers and no increased risk to public health and safety. Comments are requested to be submitted through the submissions portal by February 21, 2020.
  • Pathway 2 would provide pharmaceutical manufacturers with an opportunity to reimport prescription drugs destined for other countries under a new National Drug Code and requisite relabeling and testing to ensure pharmaco-equivalence. Comments submitted via the submissions portal on the proposed rule will be accepted through March 9, 2020.

While encouraging public comment on both publications, HHS Assistant Secretary for Health ADM Brett P. Giroir, MD, stated, “The FDA continues to assess and act on multiple opportunities to promote competition that can, in turn, help reduce drug prices and improve access to medicines for Americans. The proposed rule and draft guidance include procedures intended to protect the public’s health and safety . . . Our ultimate goal is to provide a robust program that clearly lays out procedures to import drugs that could provide lower prices while also maintaining the high quality Americans expect.”

States continue to explore options for Canadian drug importation programs. Already in 2020, 12 states have introduced legislation related to personal and wholesale importation. Additionally, New York Governor Andrew Cuomo announced his intent to form a Prescription Importation Commission tasked with reviewing potential processes for safe and cost-effective importation programs and particular products of interest during his January 8, 2020 State of the State remarks.

With regulators and legislators contemplating prescription drug importation at the state and local levels, it remains critical that any policymaking retains a focus on public health and patient safety. While the core focus and anticipated outcome of these efforts is a heavily regulated system of prescription drug (re-)importation, we remain at risk of pushing consumers to the internet in an attempt to mitigate the strain of high costs. Ill-informed consumers undertake unnecessary health risks posed by illegal online drug sellers who prioritize profits over public health. All resources, including NABP’s .Pharmacy Verified Websites Program, are steps toward promoting patient safety and actively combating illegal actors.