U.S. Sens. Tina Smith, D-Minn., continued her push to bring down the fast-rising price of insulin by introducing a bipartisan bill with Republican Sen. Bill Cassidy, R-La., focused on bringing lower-cost insulin to market.
According to a news release, the U.S. Food and Drug Administration is currently transitioning the way it regulates insulin, and Smith and Cassidy's bill-the Protecting Access to Biosimilars Act-would codify this new pathway for insulin to come to market, thus increasing market competition and driving down the cost of the lifesaving medicine.
"High insulin prices are jeopardizing the financial security of Minnesotans and Americans, and forcing some into alarming, and at times fatal, rationing," stated Smith in a release. "For the millions of people in the United States who rely on insulin, the medication is not a choice; it's a matter of survival. Patients should be able to afford the medication they need to live. Our bipartisan bill would do what's right-promote competition and make sure lower-cost insulin comes to market sooner rather than later."
Last December, the FDA issued guidance for transitioning insulin from being classified as drugs to biosimilars-which are medical products that are almost an exact copy of a product originally manufactured by a different company. The guidance provided a number of useful clarifications regarding the new drug approval pathway for biosimilar products, and issued clarification on the transition to prevent evergreening (when brand-name companies patent slight changes of old drugs and call them new drugs in order to control the market) and other tricks companies use to extend their exclusivity period, according to the news release.
Smith and Cassidy's bipartisan Protecting Access to Biosimilars Act would ensure that this guidance remains in place by:
• Subjecting insulin to the new pathway to bring low-cost, generic insulin products to market;
• Making sure these products adhere to requirements that prevent the ability of insulin manufacturers to game the exclusivity system and keep their market share and,
• Ensuring older insulin products that are now regulated as biologics do not suddenly receive the 12-year exclusivity granted to newly licensed biologics.
Reps. Diana DeGette, D-Colo., and Tom Reed, R-N.Y., co-chairs of the House Diabetes Caucus, have introduced a House companion bill.