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 backed a concept that has long been supported by Democrats, including many of those vying for the 2020 presidential nomination. Trump has 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.
Trump swiftly took to Twitter to announce the plan, saying 'Lowering drug prices for many Americans - including our great seniors! At my direction, @HHSGov @SecAzar just released a Safe Importation Action Plan. Our Governors will be very happy too!'
However, it will likely take a while before cheaper medications make their way into patients' hands, if it ever happens at all. Both Health & Human Services Secretary Alex Azar and acting Food and Drug Administration Commissioner Ned Sharpless noted hurdles lie ahead.
'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.
The Safe Drug Importation Plan describes two ways certain drugs from abroad could enter the US. It marks a major turnaround for 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.'
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.'
Four states -- Florida, Vermont, Colorado and Maine -- recently passed laws to set up drug importation programs, though they all need approval from HHS. Florida Gov. Ron DeSantis, a Trump ally, helped convince the President to support the idea earlier this year.
Azar, however, has not been quick to embrace importation.
'Canada simply doesn't have enough drugs to sell them to us for less money, and drug companies won't sell Canada or Europe more just to have them imported here,' he said in remarks about the President's blueprint to lower drug prices in May 2018.
Also, he added at the time, the last four FDA commissioners have said there's no way to effectively ensure that the medication is really coming from Canada and not a counterfeit factory in China.
Asked by reporters Wednesday why he now thinks it's safe, Azar said the drug supply chain has become more international.
'The very large distributors [are] now playing in many countries who would be able to manage a very complex, but secure, drug distribution system across borders,' he said. 'We've seen pharmacy chains similarly expand across American borders.'
Some experts, however, say importation is unlikely to ever happen. HHS' move is likely a 'bluff' to get drug manufacturers to lower their prices in the US, said Gerard Anderson, a health policy professor at Johns Hopkins University, who is working with the city of Philadelphia to try to get the agency to approve the city naloxone from the United Kingdom to treat overdoses.
It's still very difficult to guarantee that medication mail order companies based abroad are reputable and would provide the right drugs to Americans, Anderson said.
Another potential wrinkle: Canada isn't so willing to give up its drugs. A coalition of 15 Canadian medical professional and patient groups asked their government last week to protect their pharmaceutical supply. Canada already experiences drug shortages, the group says.
The request came days before Vermont Sen. Bernie Sanders, a longtime supporter of importation, traveled north with American diabetes patients seeking cheaper insulin.
Canada's Office of the Minister of Health told CNN it continues to work to ensure Canadians have 'uninterrupted access' to the medications they need.
'Our government would oppose any initiatives that could adversely affect the supply of prescription drugs in Canada or the costs for Canadians,' said Thierry Bélair, the office's press secretary.