The Trump administration took hesitant first steps Wednesday to allow the importation of certain drugs from Canada and other countries.
The historic proposal comes after President Donald Trump cast aside typical GOP opposition and pushed his health officials to find a way to approve the Republican governor of Florida’s recent request to allow the importation of lower-cost drugs. The President has made reducing drug prices a key priority for his administration — especially in the run up to the 2020 election — but has yet to enact any significant changes.
The Department of Health & Human Services, which has long raised safety concerns over importation, released a Safe Drug Importation Plan that describes two ways certain drugs from abroad could enter the US. It marks a major turnaround for HHS Secretary Alex Azar, who called importation a “gimmick” in the past.
“What we’re saying today is we’re open,” Azar said of the proposed rule, which must still be finalized. “There is a pathway. We can be convinced.”
But it will likely take a while before these lower-priced medications find their way into patients’ hands. Both Azar and acting Food and Drug Administration Commissioner Ned Sharpless noted hurdles lie ahead before importation could actually happen.
“We recognize there are operational challenges and questions that we need to overcome before these policies can be implemented,” Sharpless said, stressing that patient safety is the agency’s highest priority.
Under one scenario, states, pharmacists or drug wholesalers could submit plans to the agency for test projects on how they would import drugs approved by Health Canada. But the method also sets up many restrictions, including saying the tests would be limited in time and require regular reporting to ensure safety and costs are being met.
Insulin, however, cannot be imported from Canada, likely disappointing diabetics, some of whom have to travel north to purchase the costly, lifesaving medicine there.
The second pathway would allow manufacturers to import lower-cost versions of the drugs that they sell in foreign countries. Agency officials said drug makers are interested in doing this but have not been able to because of contracts with other players in the supply chain.
In the proposal, HHS puts the burden on states and manufacturers to convince it that importing drugs would be safe for consumers and save them money. For instance, it would be up to states to negotiate with Canadian authorities to allow their drugs to be sent to the US, said Azar.
“It is a plan to make a plan,” said Rachel Sachs, an associate law professor at Washington University, noting that little to nothing has been heard from an FDA importation working group set up last year. “It seems to mitigate the federal government’s role here.”