WASHINGTON, D.C. [07/11/19]—Today, U.S. Senators Tina Smith (D-Minn.), Dick Durbin (D-Ill.), and Kevin Cramer (R-N.D.) introduced new bipartisan legislation that would speed up approvals of lower-cost insulin products in order to help people with diabetes access the life-saving medication they need to survive.
Approximately 7.5 million Americans with diabetes rely on insulin every day to survive, yet the drug has experienced a price increase of more than 600 percent over the past two decades in the United States. Sens. Smith, Durbin, and Cramer’s legislation—called the Affordable Insulin Approvals Now Act—would help lower the price of insulin by promoting competition and bringing lower-cost products to market sooner—specifically by requiring the Food and Drug Administration (FDA) to continue reviewing lower-cost insulin applications even after the agency’s currently planned March 2020 cut-off date.
“People with diabetes in Minnesota and across the country who need insulin to survive should not be forced into economic distress or dangerous rationing practices to afford Big Pharma’s skyrocketing prices,” said Sen. Smith, a member of the Senate Health Committee. “By speeding up the FDA approval process to bring low-cost insulin products to market, we can make this life-sustaining medication more accessible and affordable for families.”
“America’s insulin pricing scandal is a disgrace. Basic insulin was first discovered nearly a century ago, yet Big Pharma’s price gouging is driving families and children to extraordinarily dangerous lengths—like rationing supplies—in order to afford a medication they need to survive. If we can create a faster path for FDA approval of generic insulin, we can finally help to lower costs and tell Big Pharma enough is enough,” said Sen. Durbin.
“More generic insulin in the market means lower costs for those in need. Our bill encourages competition and free market solutions to the rising cost of this life-saving drug,” said Sen. Cramer.
In December of last year, the FDA issued guidance to clarify implementation of the Biologics Price Competition and Innovation Act. While the intent of this action is to ease the approval pathway for lower-cost biosimilar products, it creates a perverse incentive that could delay approval of “generic” insulin. FDA’s new guidance effectively creates an application termination cliff on March 23, 2020—in which FDA will automatically reject “generic” insulin products that are in the approval pipeline during that time. As a result, this could delay approval of lower-cost insulin products for American patients.
This legislation would make sure the FDA continues to review lower-cost insulin applications past the cut-off date, and the bill is supported by Diabetes Patient Advocacy Coalition, the National Diabetes Volunteer Leadership Council, and Children with Diabetes.
Last month, Sens. Smith and Cramer introduced bipartisan legislation to bring down the cost of insulin and to hold insulin manufacturers accountable for excessive increases in the price of the life-sustaining medicine. The bill—announced in Minneapolis and introduced in remembrance of Minnesotan Alec Smith, who tragically passed away two years ago today after rationing his insulin—would provide emergency access to insulin for people in Minnesota, North Dakota, and across the country who can’t afford the skyrocketing price of the drug that they need to stay alive.