Letter to FDA Commissioner Scott Gottlieb: Opposing Drug Importation Workgroup

The Honorable Scott Gottlieb, MD
Commissioner
U.S. Food and Drug Administration

Dear Commissioner Gottlieb:

I write to share our strong concerns regarding importation in light of the U.S. Food and Drug Administration’s

(FDA) recently formed work group tasked with developing “focused drug importation policy options.”

The Council for Affordable Health Coverage (CAHC) is a broad-based alliance with a singular focus: bringing down the cost of health care for all Americans. Our membership reflects a broad range of interests—organizations representing insurers, PBMs, drug manufacturers, small and large employers, patient groups, consumers, and physician organizations.

While CAHC appreciates the work group’s aim of addressing access challenges related to certain sole-source medicines, we encourage the administration to identify ways to achieve this goal without taking a gamble on patient safety and compromising the integrity of our nation’s medication supply. As Secretary of Health and Human Services (HHS) Alex Azar has warned before, “There can be no guarantee of safety” under drug importation. Past administrations have echoed these concerns. A task force on drug importation convened by the George W. Bush administration’s HHS in 2005 concluded that, “There is no realistic level of resources that could ensure that personally imported drugs are adequately inspected to assure their safety,” while adding “Legalized importation raises liability concerns for consumers, manufacturers, distributors, pharmacies, and other entities.”