ST. PAUL — On what activists anticipated to be a celebratory first day that Minnesota's long-awaited insulin affordability law took effect, pharmaceutical companies have moved to strike it down in court.
Saturday, June 27 was the three-year anniversary of the death of 26-year-old Alec Smith, a Minnesotan with diabetes who rationed his expensive medication and died as a result. Four days later on Wednesday, July 1, dubbed by Gov. Tim Walz as Alec Smith Day, Smith's namesake insulin affordability law went into effect after more than a year of heated negotiations between state lawmakers.
At a Wednesday news conference, Walz said "for years and years" the public heard stories of Minnesotans priced out of their vital insulin.
"The horrific stories, Alec Smith and so many others, of rationing insulin or going into diabetic shock because they couldn't get it. Those days now end here in Minnesota," Walz said.
But on the eve of the law taking effect, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit against the state arguing that the law, also known as House File 3100, violates the U.S. Constitution's Fifth and Fourteenth Amendments.
James Stansel, PhRMA's executive vice president and general counsel, said in a Tuesday news release that HF 3100 "overlooks common sense solutions to help patients afford their insulin," and that manufacturers already have their own insulin affordability coupons and plans in place.
Minnesotans relying on insulin testified to the Legislature many times over the past year saying that despite coupons, existing affordability programs and health insurance, they still could not afford their insulin, which at times cost them hundreds of dollars for a limited supply. For insulin-dependent diabetics, insulin is not an optional medication -- without it, they can have permanent complications or die -- and being unable to afford their supply is an emergency.
As recently as Wednesday, 21-year-old Concordia University student Alexis Stanley, who has diabetes, said her July supply of insulin cost her $659.
PhRMA's lawsuit comes amid the coronavirus pandemic, due to which over 817,000 Minnesotans have filed for unemployment benefits. Those with diabetes are high-risk for complications or death from the novel virus.
In the three years since their son died, Smith's parents, Nicole Smith-Holt and James Holt, lobbied for their son's namesake bill before they watched and cried from the Senate gallery as lawmakers approved it in April.
Smith-Holt said at a Wednesday news conference called PhRMA's lawsuit "tragic," but said "we will not allow this to alter our path to success." She said Alec's law was passed in hopes of preventing "senseless tragedies" like her son's death from happening again in Minnesota.
"But the real tragedy here is that we are in the midst of a pandemic, a pandemic that has resulted in mass unemployment and the closing of the Canadian border, which many Minnesotans crossed to buy insulin at a fraction of what it costs in the U.S.," Smith-holt said. "Without the safety net that Alec's law provides, we're going to see more Minnesotans die and face serious, long-term health consequences because they don't have emergency access to insulin."
HF 3100 established two state programs, one long- and one short-term: Manufacturers under the law have to expand access to their long-term insulin assistance programs, as well as provide emergency insulin supplies for uninsured and low-income Minnesotans, as well as those with high-deductible insurance policies, when they are facing an emergency shortage and can't foot the bill.
PhRMA argues in its lawsuit that the law violates the Fifth and Fourteenth Amendments' Takings Clause, which prohibits the state from taking manufacturers' private property for public use without compensation.
"In this instance, the state of Minnesota is forcing insulin manufacturers to give their product to state residents for free, without any compensation from Minnesota in return," PhRMA said in its Tuesday news release.
Minnesota Attorney General Keith Ellison said in a Wednesday statement that he was "outraged" by the deaths of Smith and others with diabetes, and by PhRMA's lawsuit. With the lawsuit, Ellison said "Big Pharma is telling Minnesotans that their obscene profits come before your lives."
He said his office intends to defend Alec's law in court "with every resource we have (...) on behalf of all Minnesotans who believe that no one should die because they can’t afford their insulin. I’m defending it on behalf of all Minnesotans who believe people’s lives are more important than drug companies’ profits.”
PhRMA also argues that it is not manufacturers that determine what patients pay at their pharmacy counter for their medication: That's up to insurance companies, pharmacy benefit managers and the government to decide, they said.
In February, a spokesperson for Eli Lilly — one of three manufacturers of insulin — said via email that the list price of one vial of Eli Lilly's most commonly used insulin is $275.
Filed in the U.S. court for the district of Minnesota, the lawsuit names members of Minnesota's Board of Pharmacy MNsure board as defendants. They are seeking a permanent injunction against enforcing that law, and for the court to declare it unconstitutional.
Minnesota Sen. Michelle Benson, R-Ham Lake, who chairs the Senate's Health and Human Services Committee, said in a Wednesday statement that she was disappointed to see PhRMA's lawsuit. They had called versions of the bill unconstitutional during the legislative session, but Benson said lawmakers worked to mitigate those concerns.
“PhRMA is missing the mark by wasting time and money on this lawsuit," Benson said. "Minnesotans would be far better off if the pharmaceutical industry would focus on fairness in pricing. You shouldn’t have to be a powerful government or a special interest group to have access to fair prices."