118 HR 5547 IH: Maintaining Investments in New Innovation Act U.S. House of Representatives 2023-09-18 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I118th CONGRESS1st SessionH. R. 5547IN THE HOUSE OF REPRESENTATIVESSeptember 18, 2023Mr. Nickel (for himself, Mr. Joyce of Pennsylvania, and Mr. Davis of North Carolina) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concernedA BILLTo 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..