WASHINGTON, D.C. [04/11/2019]—Today, U.S. Senator Tina Smith (D-Minn.) continued her push to bring down the fast-rising price of insulin by introducing a bipartisan bill with Republican Senator Bill Cassidy, M.D. (R-La.) focused on bringing lower-cost insulin to market.
The Food and Drug Administration (FDA) is currently transitioning the way it regulates insulin, and Sens. 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 life-saving medicine.
You can access a summary of the bill here.
“High insulin prices are jeopardizing the financial security of Minnesotans and Americans, and forcing some into alarming, and at times fatal, rationing,” said Sen. Smith, a member of the Senate Health Committee and the Senate Diabetes Caucus. “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.”
“To lower the cost of drugs we need to increase competition,” said Dr. Cassidy. “Getting generics to market faster increases access and saves money for patients and taxpayers.”
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.
Sens. 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.
Representatives Diana DeGette (D-Colo.) and Tom Reed (R-N.Y.), co-chairs of the House Diabetes Caucus, have introduced a House companion bill.
You can read a summary of Sens. Smith and Cassidy’s bill here.
In addition, the FDA guidance issued in December intended to make it easier for lower-cost products to go through the approval process, but it creates a problematic incentive that could delay approval of generic insulin. The FDA’s new guidance effectively creates a cliff on March 23, 2020, at which time the FDA will automatically reject generic insulin products that are in the approval pipeline. Last month, Sen. Smith and Sens. Cassidy, Dick Durbin (D-Ill.), and Kevin Cramer (R-N.D.) joined together in a bipartisan effort to urge the FDA to change these recently-issued guidelines that would present approval delays for new, lower-cost insulin products—and may effectively freeze review of lower-cost competitors, potentially blocking approval of generic insulin for two years.
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