Drugmakers late Monday sued to stop the Trump administration from allowing states to import some prescription drugs.
The lawsuit is the first of what will likely be many healthcare industry legal challenges to the Trump administration's last-minute attempts to achieve policy goals before the transition in January. The importation regulation at issue was not classified by the White House to be "economically significant," while other recent drug-pricing policies advanced by the administration were.
Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage filed suit in the U.S. District Court for the District of Columbia.
Drugmakers argued that the HHS secretary could not preemptively certify that states' importation programs would not have safety risks and would save money before actually seeing the plans. HHS Secretary Alex Azar sent a certification letter to congressional leaders on Sept. 23.
"It is particularly disturbing that the administration is punting the responsibility for demonstrating safety and cost savings to state governments despite the clear requirement under federal law that the Secretary of HHS must certify that imported drugs both pose no additional risk to public safety and will lead to significant savings for the American consumer," said PhRMA Executive Vice President and General Counsel James Stansel said.
Legal experts had expected that Azar's certification could be challenged in court. HHS acknowledged in rulemaking documents that it was unable to estimate cost savings because the agency couldn't predict the scope of states' plans. Rachel Sachs, an associate professor at the Washington University School of Law, and University of Michigan law professor Nicholas Bagley wrote in a New England Journal of Medicine article published in May that evaluation of a program should come before certification.
"HHS may not have the legal authority to certify to Congress that entirely hypothetical state plans will save money and not pose health risks until the agency has had an opportunity to evaluate them," Sachs and Bagley wrote.
Florida formally submitted its state importation plan to HHS on Monday. The state has already faced roadblocks to implementing the plan, as no companies bid to be a vendor to administer the state's importation program, Kaiser Health News reported. Bids were due in September.
Potential vendors in other states have also been skittish to have a public association with the program for fear of retribution from drugmakers.
