The Pharmaceutical Research and Manufacturers of America (PhRMA) is combining forces with two other groups to challenge the FDA final rule allowing broad, state-by-state importation of drugs from Canada.
The rule, issued in September, followed a directive from the Trump Administration to widen consumer access to lower drug prices.
The litigation cites “significant safety risks” as arising from the cross-border passage of drugs “without drug manufacturers’ authorization or oversight.”
PhRMA is joined at the plaintiff’s table by the Partnership for Safe Medicines and the Council for Affordable Health Coverage.
FDA’s co-defendants are HHS and Stephen Hahn, the FDA’s commissioner.
In announcing the action, PhRMA’s general counsel, James Stansel, states:
“It is alarming that the administration chose to pursue a policy that threatens public health at the same time that we are fighting a global pandemic. … [T]he administration is willing to divert precious FDA resources away from these efforts and to expose Americans to the risks that come with drug importation schemes.”
Along with the announcement, the groups have posted the 70-page complaint.