3 Groups Sue to Block Drug Import Rule

Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage have filed suit in DC federal court to block HHS and FDA from implementing a program to permit the importation of some drugs from Canada. The suit asks the court to hold unlawful, set aside, and permanently enjoin implementation of the agencies’ proposed certification and final rule.

Under the HHS/FDA plan, pharmacists and drug wholesalers, acting under state-sponsored programs, could import certain prescription drugs from Canada into the U.S. without drug manufacturers’ authorization or oversight, the groups say in a joint statement.

Their complaint says that the final rule disregards key protections of the Federal Food, Drug, and Cosmetic Act that are designed to ensure patient safety. They note that a section of the act permits some drug importation, but only after the HHS secretary has certified that such importation (1) poses no additional risk to the public’s health and safety and (2) results in a significant reduction in the cost of covered products to the American consumer.

“In this final rule, HHS secretary Alex Azar has made conclusory statements as to safety and cost savings in his ‘certification’ with no supporting evidence and while punting the responsibility for safety and cost savings to state governments,” the statement says.

The groups also say there is no indication that the final rule will reduce costs to actual American patients. “In the preamble to both the proposed and final rule, HHS has acknowledged that it cannot quantify the savings, if any, that would result from its rule, even classifying it as ‘not economically significant’ for purposes of review by the Office of Management and Budget,” they write. “Indeed, in the budget document released with the rule, the cost savings chart was left blank, suggesting cost savings could not be calculated.”