July 03, 2020
The US drug industry trade association PhRMA is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.
The Pharmaceutical Research and Manufacturers Association (PhRMA) filed the complaint in the US District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect.
The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.
Advocates said they were appalled by the PhRMA action.
PhRMA Says Law Is Unconstitutional
In the filing, PhRMA's attorneys said the law is unconstitutional. It "order[s] pharmaceutical manufacturers to give insulin to state residents, on the state's prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way," said the complaint.
"A state cannot simply commandeer private property to achieve its public policy goals," the PhRMA lawyers argued.
The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to "a great number of patients."
The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would "be compelled to provide 173,800 monthly supplies of free insulin" just in the first year.
"No one living with diabetes should be forced to ration or go without their life-saving insulin because they can't afford it," said PhRMA Executive Vice President and General Counsel James C. Stansel in a statement.
The law, said Stansel, "overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free."
Advocates Decry Suit
Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Governor Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.
It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication.
Manufacturers can be fined $200,000 per month for not complying.
Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a "bad move."
Rajkumar, the Edward W. and Betty Knight Scripps Professor of Medicine at Mayo, noted that it has strict limits and is aimed to help patients in emergent need.
"There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger," Rajkumar told Medscape Medical News. "The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of Pharma profits," he said.
Alec Smith's mother, Nicole Smith-Holt, who is active with T1International's #insulin4all campaign, took to Twitter to express her anger.
"Throwing up road blocks to securing affordable insulin for the people of MN, haven't they taken enough innocent lives? How many more bodies are they looking for?" she tweeted. "When are they going to realize we are not going to stop fighting?"
T1International said in a statement: "It is clear that the pharmaceutical industry can see only one thing —their bottom line," and promised that patients would not give up.
"We will not stop showing them the real price we pay for their greed," said the organization.
Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.
"I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn't what they wanted," she tweeted.
"They were buying time to protect their profits. Yeah, we're not done here," she said in the tweet.