For the first time, the FDA and Trump Administration say they are open to importing prescription drugs from Canada as a way to save consumers money, but one of the pathways to do so would exclude insulin and other biological products, such as Humira, Lantus and Enbrel.
The secretary of Health and Human Services, Alex Azar, said the new proposal for Canadian drug imports still needs to go through a comment period and, if approved, would put the burden on states, pharmacies and wholesalers.
"We wanted to announce this new, historic, open-mindedness so that they could start thinking about how they would plan for this," Azar said.
But the only way insulin and other biological products will make their way across the border is through a second pathway.
"Pharmaceutical companies themselves could bring their own drugs in from outside the country in a way that would let them lower their list price on those drugs here in the United States," Azar said.
"That's concerning," said Nicole Smith-Holt, who lost her son Alec Smith after he tried to ration insulin that he could no longer afford.
Smith-Holt says she has a hard time trusting that the three manufacturers of insulin will go to the trouble of importing their own drugs in the name of saving patients money.
"We know that the Eli Lilly, Novo Nordisk and Sonofi haven't been agreeable to much of anything these days so I can't imagine that they would want to lose that level of profit willingly," she said.
Still, she says she is glad to see the topic of affordable insulin gaining attention and scrutiny. In May, she was amount a handful of Minnesota women who drove to Canada because insulin is 10 times more expensive in the United States. Since then, the group has taken three trips that have attracting national and international media attention.
Smith-Holt, and fellow #insulin4all advocate, Quinn Nystrom, were even guests at the Democratic Presidential debate in Detroit on Tuesday.
"Every time they mentioned insulin it was a win for us," Smith-Holt said. "It brings it that much higher on the level of importance."
Nystrom says she is happy to see the Trump administration taking up the issue, but says there is more to be done.
"I will give the President credit for any baby step that is moving in the right direction," Nystrom said. "But we don't have years. We have weeks. We need an executive order and we need Congress to act quickly and swiftly because we don't have time on our side."