H.R. 7693 — Leo’s Law

This section extends specified regulatory exclusivity periods by 180 days for covered orphan drugs (i.e., drugs designated as orphan drugs for a rare disease or condition under section 526(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bb(a)], for which an investigational new drug application under section 505(i) [21 U.S.C. 355(i)] was submitted during the COVID-19 emergency period—beginning December 1, 2019, and ending no later than 120 days before termination of the public health emergency under section 1135(g)(1)(B) of the Social Security Act [42 U.S.C. 1320b-5(g)(1)(B)]—followed by approval of a new drug application under section 505(b), biologics license application under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], or supplement with no approved non-rare disease indications), provided such periods have not expired. The extended periods include (1) the 12-year exclusivity for orphan biosimilars under section 351(k)(7)(A) of the Public Health Service Act [42 U.S.C. 262(k)(7)(A)]; (2) the 5-year new chemical entity exclusivity under clauses (ii) of section 505(c)(3)(E) and (j)(5)(F) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355]; (3) the 3-year clinical investigation exclusivity under clauses (iii) and (iv) of those same provisions; (4) the 7-year orphan drug exclusivity under section 527(a) [21 U.S.C. 360cc(a)]; and (5) corresponding patent-related approval delay periods for section 505(b)(2) or (j) applications with paragraph (II), (III), or (IV) patent certifications. It also extends conforming partial exclusivity periods by 180 days, including (1) the 4-year period under section 351(k)(7)(B) of the Public Health Service Act and (2) the 4-year, 48-month, and 7.5-year periods under clauses (ii) of section 505(c)(3)(E) and (j)(5)(F) of the Federal Food, Drug, and Cosmetic Act. (Thus, these extensions provide six additional months of FDA market protection barring approval of competing drugs, biosimilars, or generics for the same rare disease or condition.) The provision takes effect upon enactment without requiring agency guidance or regulations.