Measure Would Force FDA to Continue & Expedite Review of Generic Insulin Applications

WASHINGTON, D.C. – U.S. Senator Cindy Hyde-Smith (R-Miss.) today cosponsored legislation to ensure the availability of more affordable generic insulin for tens of thousands of Mississippians who require the life-saving drug.

The Affordable Insulin Approvals Now Act (S.2103) would make insulin costs more affordable by expediting federal approvals of lower-cost, generic, and “follow-on” insulin products.

“Wider availability of generic insulin could lower the cost of care for people in Mississippi who rely on insulin to treat their type 1 and type 2 diabetes,” Hyde-Smith said.  “This legislation would prevent needless delay and ensure the FDA allows for greater competition and free market forces to drive down insulin prices as more generic insulin options come online.”

According to the American Diabetes Association, diabetes affects more than 400,000 people in Mississippi, or 17.1 percent of the adult population.  Nationally, approximately 7.5 million of the 30 million Americans with type 1 or type 2 diabetes rely on daily insulin injections to survive.

In December 2018, FDA issued guidance to clarify implementation of the Biologics Price Competition and Innovation Act that effectively creates an application termination cliff in March 2020.  At that point, FDA would automatically reject “generic” insulin products that are in the approval pipeline, which would needlessly delay approval of lower-cost insulin products.

S.2103 would override that FDA policy by specifically requiring FDA to continue to review already-filed generic insulin applications even after next March.

Greater generic insulin supplies could help lower overall insulin prices, which have increased more than 600 percent over the past two decades in the United States.  In contrast, costs have remained relatively low in other countries.

The Diabetes Patient Advocacy Coalition, the National Diabetes Volunteer Leadership Council, and Children with Diabetes support S.2103, which was introduced by Senators Dick Durbin (D-Ill.) and Kevin Cramer (R-N.D.).