S. 1128 · 118th Congress
Ensuring Access to Generic Medications Act
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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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This bill authorizes an applicant seeking Food and Drug Administration (FDA) approval for a generic drug (or biosimilar product) to sue to correct or delete patent information provided by the maker of the reference drug (or reference biological product).
What it does: CRS summary · Introduced in Senate · Mar 30, 2023
Ensuring Access to Generic Medications Act
This bill authorizes an applicant seeking Food and Drug Administration (FDA) approval for a generic drug (or biosimilar product) to sue to correct or delete patent information provided by the maker of the reference drug (or reference biological product).
Typically, a generic drug is a lower-cost version of a reference drug that gets introduced after the patents covering a reference drug have expired. When the maker of the reference drug first applies for FDA approval to sell the drug, the maker must provide various information to the FDA about the patents that it believes cover the drug, including in the form of use codes that describe any methods of using the drug that the reference drug maker believes are covered by a patent.
Use code information is publicly available and is intended to help inform generic drug makers about the patents that may be covering the reference drug. The FDA has stated that overbroad or ambiguous use codes may delay approval of generic drugs.
Under this bill, an applicant seeking FDA approval for a generic drug may sue for an order requiring the applicable reference drug maker to correct or delete use code information that is overly broad or inaccurate, such as a use code that does not correspond to a patent claiming an FDA-approved method of using the reference drug.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Ensuring Access to Generic Medications Act
Latest action (Mar 30, 2023): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Commerce · Origin: Senate · Introduced: Mar 30, 2023
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.