Bill would prevent misuse of FDA petitions that delay generic drug approvals
WASHINGTON, D.C. – U.S. Senators Susan Collins and Jeanne Shaheen (D-NH) have reintroduced the Ensuring Timely Access to Generics Act to help lower the cost of prescription drugs. The bipartisan legislation would increase competition for generic drugs by providing better oversight of the citizen petition process at the Food and Drug Administration (FDA).
“We know that increasing generic drug competition is key to lowering prescription drug prices for individuals and reducing drug spending overall. On average, generic drugs cost 80 to 85 percent less than their brand-name equivalents,” said Senator Collins. “This bipartisan bill would help address barriers that currently delay market entry for generic drugs, improving competition and saving patients money.”
“Addressing the soaring price of prescription drugs is a tangible way that Congress can help lower health care costs and give families some breathing room in their budgets,” said Senator Shaheen. “By increasing competition, our bipartisan legislation would help bring more generic drugs to the market and reduce costs for the Granite State families who rely on them.”
The Ensuring Timely Access to Generics Act would promote generic drug competition through better oversight of the citizen petition process at the FDA. The citizen petition process allows interested stakeholders, including drug companies, to bring concerns to the FDA’s attention regarding pending applications. Currently, the process is being exploited by bad actors who file citizen petitions in order to delay the approval of generic competitors and extend their patent protections. This legislation ensures the FDA can reject citizen petitions if they believe its primary purpose is to delay the approval of an application, thereby increasing competition in the marketplace and lowering costs for patients.
Earlier this year, Senator Collins joined Senators John Hickenlooper (D-CO), Tom Cotton (R-AR), and Peter Welch (D-VT) to introduce the bipartisan Skinny Labels, Big Savings Act to lower drug prices by accelerating the approval of generic drugs and creating legal protection for generic drug manufacturers who obtain “skinny label” FDA approvals. Federal law permits the FDA to approve generic and biosimilar drugs via a “skinny label” that leaves out uses of the drug that are still protected by patents.
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