HYDE-SMITH SAYS FDA SHOULD FOLLOW LAW TO EXPEDITE APPROVAL OF LOWER-COST INSULIN PRODUCTS

HYDE-SMITH SAYS FDA SHOULD FOLLOW LAW TO EXPEDITE APPROVAL OF LOWER-COST INSULIN PRODUCTS

Miss. Senator Successfully Advocated for Inclusion of Insulin Affordability Provisions in FY2020 Appropriations Measure

WASHINGTON, D.C. – U.S. Senator Cindy Hyde-Smith (R-Miss.) today said the Food and Drug Administration (FDA) must act expeditiously to implement legislation she cosponsored to help reduce prices by accelerating the approval of lower-cost, generic insulin products.

Hyde-Smith cosponsored the Affordable Insulin Approvals Now Act (S.2103), a measure incorporated into the Consolidated Domestic and International Assistance Bill (HR.1865), a year-end appropriations package signed by President Trump on Dec. 20, 2019.

“The FDA now has a clear mandate to streamline approval of generic insulin products, which could be a game changer for Mississippians and all diabetics who need access to more affordable life-saving medication,” said Hyde-Smith, who as a member of the Senate Appropriations Committee advocated for the inclusion of S.2103 in the FY2020 appropriations package.

“The FDA should act expediently to adhere to the law.  There is no need to delay approval of these generic insulin products, which should increase competition and lower the cost of insulin for those with type 1 and type 2 diabetes,” she said.

Adoption of the insulin affordability legislation stops the FDA from automatically rejecting “generic” insulin products already in the approval process, as outlined in guidance issued by the agency for implementing the Biologics Price Competition and Innovation Act.  By law, the FDA must now continue reviewing already-filed generic insulin applications past a self-imposed March 2020 deadline.

Increasing the availability of generic insulin supplies would help lower overall insulin prices, which have increased more than 600 percent over the past two decades in the United States.

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

The Diabetes Patient Advocacy Coalition, the National Diabetes Volunteer Leadership Council, and Children with Diabetes endorsed S.2103, which was introduced in the Senate last July.

Hyde-Smith serves on Senate appropriations subcommittees with jurisdiction over the FDA, as well as the U.S. Department of Health and Human Services and related agencies.

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