PhRMA sues Trump government over drug importation rule — days before it's set to be effective
Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile, but the trade group has also argued that it may even be illegal.
Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.
If PhRMA and its two allies, the Partnership for Safe Medicines and the Council for Affordable Health Coverage, prevail, no states will ever get an importation plan through.
If anyone still remembers, a month before the election the agency completed a rulemaking process that opened the door for pharmacists and wholesalers to import. But they must set up special programs, apply for it and make sure the drugs meets certain requirements including significant cost reductions to the customer. The products must also be relabeled and tested.
For PhRMA, the HHS is violating federal law and flouting key protections of the Federal Food, Drug, and Cosmetic Act.
“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,” James Stansel, the organization’s general counsel, said in a statement.
Specifically, its litigation alleges that by outsourcing the gate-keeping role to state governments, HHS Secretary Alex Azar’s certification is contrary to Section 804 of the FDCA. The section stipulates that HHS can only permit importation if it certifies to Congress that the implementation would pose no additional public health risk and result in a significant reduction.
Citing “well-documented safety concerns regarding importation” — a long-running message that features prominently on its webpage dedicated to the topic — PhRMA piled on the implementation of the program as a “false promise.”
The whole idea has been unpopular among industry execs, many of whom argue importation won’t work but might hurt the industry’s incentives.
Even before the lawsuit, it wasn’t clear how widespread drug importation could be. Florida failed to attract a single bidder for its $30 million contract to set up and operate a program for the state. Canada — where the cheaper drugs would theoretically come from — has vowed to ensure there won’t be a shortage of drugs within its borders, which could mean stopping its own pharmacies from exporting the medicines.