Moline, IL-(ENEWSPF)- U.S. Senator Dick Durbin (D-IL) Monday discussed the Affordable Insulin Approvals Now Act, a bipartisan bill to speed up approvals of lower-cost, generic, and “follow-on” insulin products in order to help reduce costs of the life-saving drug. 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. This legislation, introduced by Durbin last month, along with U.S. Senators Kevin Cramer (R-ND) and Tina Smith (D-MN), would lower the price of insulin by promoting competition and bringing generic products to market sooner—specifically by requiring FDA to continue reviewing generic insulin applications even after the agency’s currently planned March 2020 cut-off date.
“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,” Durbin said. “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.”
In December 2018, FDA issued guidance to clarify the 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 in future years, it could delay approval of “generic” insulin in the short run. 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 who are struggling with skyrocketing insulin prices. The bipartisan Affordable Insulin Approvals Now Act is supported by Diabetes Patient Advocacy Coalition, the National Diabetes Volunteer Leadership Council, and Children with Diabetes.
Insulin was first discovered in 1921. The Nobel Prize-winning researchers sold the patent to the University of Toronto for just $1 because they believed that insulin should be made widely available to everyone, without worrying about the cost. However, the price of insulin today is the subject of anti-competitive practices and constant price increases.
There are only three primary insulin manufacturers in the U.S., Novo Nordisk, Eli Lilly, and Sanofi. Lantus, a popular long-acting insulin, cost $35 when it was first introduced in 2001. Within the past few years, the price of a Lantus vial has skyrocketed to more than $372, while that same exact drug was sold in France for $46, and $67 in Canada. The United States represents only 15 percent of the global insulin market, yet generates nearly half of pharma’s revenue on insulin.
Durbin has also introduced two other new pieces of legislation this year to specifically help address the outrageous prices of insulin.
FLAT Prices Act
In February, Durbin introduced the Forcing Limits on Abusive and Tumultuous (FLAT) Drug Prices Act which aims to prevent pharmaceutical companies from hiking the price of prescription drugs, by penalizing them for price increases of more than 10 percent through reductions in their reducing the government-granted monopoly period.
In April, Durbin introduced the bipartisan Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act which aims to crack down on pharmaceutical patent abuses that shield their drugs from generic competition. Specifically, the REMEDY Act would narrow the barriers that generic drugmakers face when seeking FDA approval, which will help to bring lower-cost competition to the drug market and remove an incentive for brand-name pharmaceutical companies to amass excessive numbers of follow-on. Sanofi’s Lantus insulin has obtained 45 follow-on patents after FDA approval in 2000, which has extended its effective monopoly period for 37 years.
This is a release from U.S. Senator Dick Durbin’s office.