Three pharma industry groups are suing HHS and the FDA to block a rule that would allow the importation of certain prescription drugs from Canada.
The groups filing the suit are Pharmaceutical Research and Manufacturers of America, Partnership for Safe Medicines and the Council for Affordable Health Coverage.
President Donald Trump signed an executive order in July to allow states, wholesalers and pharmacies to import FDA-approved drugs from Canada and other countries where drug prices are significantly lower.
The groups argue that the final rule disregards key protections under the federal Food, Drug, and Cosmetic Act that ensure patient safety. The groups also say that there is no indication that the final rule would reduce costs to patients.
"The bottom line is that the administration has violated federal law by proceeding without proper certification and, in doing so, is putting the health and safety of Americans in jeopardy," said PhRMA Executive Vice President and General Counsel James Stansel.