HR1672-119

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— 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 by adding at the end the following new paragraph: 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. (4)Advanced drug product definedFor 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..