Maintaining Investments in New Innovation Act

Bill: 118-s-476
Sponsor: full_name: Sen. Menendez, Robert [D-NJ]
Introduced: 2023-02-16
Policy area: Health
Subjects: Genetics

Medicare

Prescription drugs
Latest action: action_date: 2023-02-16
text: Read twice and referred to the Committee on Finance.

Summaries:
action_date: 2023-02-16
action_desc: Introduced in Senate
text: <p><b>Maintaining Investments in New Innovation Act</b></p> <p>This bill requires drug products with genetically targeted technology to have had market approval for at least 11 years in order to qualify for the Medicare Drug Price Negotiation Program. (The program requires the Centers for Medicare &amp; Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation.)</p>

tv_txt: II 118th CONGRESS 1st Session S. 476 IN THE SENATE OF THE UNITED STATES February 16, 2023 Mr. Menendez (for himself and Mrs. Blackburn ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XI of the Social Security Act to protect access to genetically targeted technologies.

1. Short title This Act may be cited as the Maintaining Investments in New Innovation Act . 2. Amendment to definition of qualifying single source drug Section 1192(e) of the Social Security Act ( 42 U.S.C. 1320f–1(e) ) is amended— (1) in paragraph (1)(A)(ii), by inserting (or, in the case of an advanced drug product (as defined in paragraph (4)), 11 years) after 7 years ; and (2) by adding at the end the following new paragraph: (4) Advanced drug product defined For purposes of paragraph (1)(A)(ii), the term advanced drug product means a drug that incorporates or utilizes a genetically targeted technology (as defined in section 529A(c)(2) of the Federal Food, Drug, and Cosmetic Act) that may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene or its associated gene product. .