Ensuring Access to Generic Medications Act

Bill: 118-s-1128
Sponsor: full_name: Sen. Hassan, Margaret Wood [D-NH]
Introduced: 2023-03-30
Policy area: Commerce
Latest action: action_date: 2023-03-30
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2023-03-30
action_desc: Introduced in Senate
text: <p><b>Ensuring Access to Generic Medications Act</b></p> <p>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). </p> <p>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 <a href="https://www.accessdata.fda.gov/scripts/cder/ob/results_patent.cfm"><i>use codes</i></a> that describe any methods of using the drug that the reference drug maker believes are covered by a patent. </p> <p>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.</p> <p>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. </p>

tv_txt: II 118th CONGRESS 1st Session S. 1128 IN THE SENATE OF THE UNITED STATES March 30, 2023 Ms. Hassan (for herself and Mr. Braun ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish special rules relating to information provided with respect to drug applications concerning method of use patents.

1. Short title This Act may be cited as the Ensuring Access to Generic Medications Act . 2. Special rules relating to method of use patents Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended by adding at the end the following: (z) Cause of action relating to drug use codes (1) In general In the case of an application under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act with respect to which the applicant seeking approval includes in the application a statement that a patent claiming a method of use does not claim a use for the drug that is the subject of such application, as described in subsection (b)(2)(B) or (j)(2)(A)(viii), or in the case of an application under such section 351(k), as otherwise required by the Secretary, the sponsor of the application under subsection (b)(2) or (j) or such section 351(k) described in paragraph (2) may file a civil action in an appropriate district court of the United States against the holder of the approved application for the applicable reference drug or reference product seeking a court order requiring the holder to correct or delete information relating to a use code submitted by the holder of the reference drug or reference product with respect to such patent claiming a method of use, on the ground that such use code— (A) does not correspond to a patent that claims the reference drug or reference product for which the application was approved; (B) does not correspond to a patent that claims an approved method of using the reference drug or reference product; or (C) is overly broad or otherwise inaccurate or inappropriate. (2) Rule of construction Nothing in this subsection shall be construed to affect the application of subsection (j)(5)(C)(ii). (3) Definition For purposes of paragraph (1), the term use code means the information relating to a patent claiming a method of using a drug that is approved under section 505 of this Act or under section 351 of the Public Health Service Act, as applicable, based upon information submitted by the drug sponsor or holder of the approved application or licensure pursuant to section 314.53(c)(2)(ii)(P)(3) of title 21, Code of Federal Regulations (or any successor regulations). .