Maintaining Investments in New Innovation Act

Maintaining Investments in New Innovation Act

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 & 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.)

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 476 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                 S. 476

   To amend title XI of the Social Security Act to protect access to 
                   genetically targeted technologies.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Maintaining Investments in New 
Innovation Act''.

SEC. 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.''.
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