Pub. L. 119–21, title VII, § 71203, July 4, 2025, 139 Stat. 321, provided that, applicable with respect to initial price applicability years (as defined in section 1320f(b) of this title) beginning on or after Jan. 1, 2028, subsection (e) of this section is amended as follows:

(1) in paragraph (1), in the matter preceding subparagraph (A), by striking “and (3)” and inserting “through (4)”

(2) in paragraph (3)(A)—

(A) by striking “only one rare disease or condition” and inserting “one or more rare diseases or conditions”; and

(B) by striking “such disease or condition” and inserting “one or more such rare diseases or conditions (as such term is defined in section 360bb(a)(2) of title 21)”; and

(3) by adding at the end the following new paragraph:

“(4) Treatment of former orphan drugs

“In the case of a drug or biological product that, as of the date of the approval or licensure of such drug or biological product, is a drug or biological product described in paragraph (3)(A), paragraph (1)(A)(ii) or (1)(B)(ii) (as applicable) shall apply as if the reference to ‘the date of such approval’ or ‘the date of such licensure’, respectively, were instead a reference to ‘the first day after the date of such approval for which such drug is not a drug described in paragraph (3)(A)’ or ‘the first day after the date of such licensure for which such biological product is not a biological product described in paragraph (3)(A)’, respectively.”

See 2025 Amendment notes below.

Section 52 of the Internal Revenue Code of 1986, referred to in subsecs. (d)(2)(B)(i) and (f)(1)(C)(i), is classified to section 52 of Title 26, Internal Revenue Code.

Section 262(a) of this title, referred to in subsec. (e)(2)(B)(ii)(I), was in the original “section 351(a) of such Act” and was translated as reading “section 351(a) of the Public Health Service Act”, to reflect the probable intent of Congress.

Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, referred to in subsec. (f)(1)(B)(ii)(I)(bb), is section 1112 of Pub. L. 108–173, which is set out in a note under section 355 of Title 21, Food and Drugs.

2025—Subsec. (e)(1). Pub. L. 119–21, § 71203(a)(1), substituted “through (4)” for “and (3)”.

Subsec. (e)(3)(A). Pub. L. 119–21, § 71203(a)(2), substituted “one or more rare diseases or conditions” for “only one rare disease or condition” and “one or more such rare diseases or conditions (as such term is defined in section 360bb(a)(2) of title 21)” for “such disease or condition”.

Subsec. (e)(4). Pub. L. 119–21, § 71203(a)(3), added par. (4).

2022—Subsec. (a). Pub. L. 117–169, § 11002(a)(1)(A), inserted “and subsection (b)(3)” after “the previous sentence” in concluding provisions.

Subsec. (b)(1)(C). Pub. L. 117–169, § 11002(a)(1)(B)(i), added subpar. (C).

Subsec. (b)(3). Pub. L. 117–169, § 11002(a)(1)(B)(ii), added par. (3).

Subsec. (f). Pub. L. 117–169, § 11002(a)(1)(C), added subsec. (f).

Pub. L. 119–21, title VII, § 71203(b), July 4, 2025, 139 Stat. 321, provided that: “The amendments made by subsection (a) [amending this section] shall apply with respect to initial price applicability years (as defined in section 1191(b) of the Social Security Act (42 U.S.C. 1320f(b))) beginning on or after January 1, 2028.”

Pub. L. 117–169, title I, § 11002(c), Aug. 16, 2022, 136 Stat. 1862, provided that: “The Secretary of Health and Human Services shall implement this section [amending this section and sections 1320f–2, 1320f–5 to 1320f–7, and 1396r–8 of this title], including the amendments made by this section, for 2026, 2027, and 2028 by program instruction or other forms of program guidance.”