WASHINGTON, D.C. [05/23/2019]—A number of measures championed by U.S. Senator Tina Smith (D-Minn.) were included in the bipartisan package to address the rising cost of health care released today by the Senate Health Committee, including Sen. Smith’s efforts to help bring lower-cost insulin and generic drugs to market.

Sen. Smith said both her bipartisan Protecting Access to Biosimilars Act and the Ensuring Innovation Act were added to the package, and her work with colleagues to increase price transparency by strengthening health care databases is also included.

“The high costs of health care are jeopardizing the financial security of Americans and forcing them to make tough decisions,” said Sen. Smith, a member of the Senate Health Committee. “Patients should be able to afford the medication they need to live, and I’m glad my efforts to promote competition and make sure lower-cost insulin and generics are able to come to market sooner rather than later are included in this bipartisan legislation.”

The Food and Drug Administration (FDA) is currently transitioning the way it regulates insulin, and 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.

The 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.

Sen. Smith’s other piece of legislation included in the larger package—the Ensuring Innovation Act—would tackle the practice of “evergreening,” in which pharmaceutical manufacturers claim new innovations when they make insignificant modifications to their products in order to extend their monopolies. Currently, pharmaceutical companies are able to extend their patents for five years when they make minor, insignificant changes to a drug. The FDA tried to solve this problem by making it so that they only grant these patent exclusivities to drugs that truly have a new chemical entity, but a recent district court decision invalidated the agency’s ability to block this practice. Sen. Smith’s bipartisan bill would ensure the FDA has the ability to curb this practice.

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