As the U.S. House of Representatives took up articles of impeachment Wednesday against President Trump, U.S. Secretary of Health and Human Services Alex Azar appeared with Gov. Ron DeSantis to announce progress toward importing cheaper prescription drugs from Canada.
The timing was in no way political, DeSantis said.
“If they would have had this ready last month, we would have done it last month,” he said, referring to the federal action and the announcement in the state Capitol by the governor and top state and federal agency chiefs.
As for the impeachment, DeSantis was dismissive.
“Everyone in this room knows how all of this is going to end. I think that’s why it has lost support with the public and it’s not something that is energizing a lot of folks in the middle,” he said.
Regarding pharmaceuticals, Azar’s department issued a notice of proposed rulemaking that opens a 75-day public comment period for a regulation that would allow Florida and other states to shop in Canada for drugs for distribution through state and county health programs, including the Florida Department of Corrections.
At least four states have expressed interest, he said.
Additionally, Azar released draft guidance for pharmaceutical companies that want to import drugs into the United States that they manufactured overseas for overseas markets, often at less cost. That might open a path to cheaper drugs for individual Floridians who don’t depend on state health programs including Medicare.
The project has been a high priority for the Republican governor, who has traveled several times to The Villages, the sprawling retirement community in Central Florida, to promote the idea, and who encouraged the Legislature to authorize it during the spring legislative session.
Congress voted in 2003 to allow importation of pharmaceuticals but no presidential administration had tried it until now.
It’s still not clear when the cheaper drugs might flow. The state has already sent the federal government its plan for how the system might work, but would have to update its own regulations to comport with federal rulemaking. Officials said the process might take years.
“This is only one step. And I’ve always said, there is no silver bullet with this,” DeSantis cautioned.
“But this is a step that no one’s been willing to take for almost 20 years. All the way back to 2003, you’ve had presidents of both parties, you’ve had secretaries of both parties, and yet until now we haven’t done it,” DeSantis said.
The Florida Agency for Health Care Administration, or ACHA, has identified 150 drugs that could be eligible for import from Canada for use by state agencies. The state would hire a wholesaler or pharmacy to manage the imports strictly within federal guidelines governing documentation, labeling, tracking supplies, and compliance with FDA regulations.
“Just for Corrections – a quarter of their health care budget is prescription drugs,” DeSantis said. “Even if you get some modest saving out of this, for them that could be tens of millions of dollars in saving for the state of Florida.”
The U.S. Food and Drug Administration does not regulate drug prices, said Assistant Secretary for Health Brett Giroir, the acting food and drug commissioner, but “would continue to assess and act on multiple opportunities to promote competition that can, in turn, also help reduce drug prices and improve access to medicine for Americans.”
The Canadian government, which pays less for drugs because it negotiates prices with the pharmaceutical industry, is on record against allowing its market to be siphoned into the United States. Legislation that has cleared the U.S. House would apply allow similar negotiations for the U.S. market.
“We hope they’ll work with us. I think they’re obviously concerned about their own system but, as long as they’re getting lower prices – as long as they’re free-riding off of American investment and innovation – the president and I are committed to ending foreign free riding,” Azar said.
As for the safety of these imported drugs, DeSantis emphasized that Canada and the United States both deploy stringent regulations. “It’s not going to be like, just go on some website that’s posted in like Thailand or something and start buying,” he said.
“For years, the challenge has been: how could we possibly connect those two [Canadian and U.S.] systems up in a way that would not allow foreign entities or unauthorized entities to bring adulterated, counterfeit, unapproved products into that closed system,” Azar said.
Given the development of global production and distribution chains for prescription drugs, the Trump administration now feels it’s safe to proceed. The only real difference between the drugs is the country-specific labeling, he said.
“What we are not is saying that people can or should go online and buy from unauthorized so-called Canadian pharmacies to get drugs. You’re taking your life in your own hands when you do that,” Azar said. These, he continued, might come from anywhere and merely pass through Canadian territory on the way to the consumer and might be adulterated and dangerous.
Azar, who once denounced such importation schemes as an unworkable “gimmick,” said his mind had been changed by an evidence of the security of global supply chains that transcend national boundaries.
“For the career officials at the FDA to be willing to say, ‘We believe there is an approach that could connect the Canadian and American systems together with safe importation of drugs through this business-to-business type approach – it’s a very historic day. And it’s the result of very careful evaluation. That’s why it has taken some time.”