Kelly's generic insulin proposal aims to address soaring costs
WASHINGTON, D.C. - For the 30 million Americans living with diabetes, the cost of insulin can sometimes be too much.
“Some families pay upwards of $1,800 a month just for their insulin,” according to LaShawn McIver, senior vice president of government affairs and advocacy at the American Diabetes Association.
The price of the life-saving drug is skyrocketing: up nearly
600 percent since 2001, according to data compiled by Endocrine.org. Just three companies make it brand-name insulin and what’s known as an “authorized generic.” But there is no true generic on the market.
However, U.S. Rep. Mike Kelly (R-Pa.) is pushing to change that.
“I’ve had people say why do you want a generic, that’s not the same as the real thing,” Kelly said. “I say, it’s the exact same thing.”
This week, Kelly – a Type-2 diabetic himself – introduced the MAGIC (Market Access for Generic Insulin Competition) Act, which would pave the way for the first true generic form of insulin on the market.
“When these and other companies are able to develop a generic, the price of that product will come down,” Kelly said. “It really takes a great burden off the people we represent.”
U.S. Rep. Tom Reed (R-N.Y.) co-chairs the Congressional Diabetes Caucus. Reed’s son is a Type-1 diabetic, meaning he needs insulin to live.
“It needs to be done in order to have access to your choice of insulin that works for you at the lowest cost,” Reed said of approving a generic.
In their way: red tape at the Food and Drug Administration, which does not permit generic insulin production. The deadline to make that happen is quickly approaching is set for March 2020. And if that doesn’t happen?
“Then, the opportunity to make a generic would go away forever,” Kelly said. “Our concern is to make sure that window never closes.”
Kelly wrote the FDA in July asking why insulin was not among the drugs categorized as a synthetic peptide drug product in 2017. Such a move would allow for generic insulin production. The FDA has not yet responded to his letter, he said.
An FDA spokesperson declined to comment when asked if the administration would cut the red tape itself ahead of the 2020 deadline.
“The FDA does not comment on pending legislation,” FDA Press Officer Sandy Walsh said via email Wednesday.
Until then, industry experts expect some patients will continue making life-threatening decisions just to make ends meet.
“They may ration their insulin,” McIver said. “They may go without insulin, which is very dangerous both in the short and long term.”