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H.R. 1262 — what changed

Mikaela Naylon Give Kids a Chance Act

From Introduced in House to Reported in House. 3 sections amended and 2 added between Introduced in House and Reported in House.

Sec. 4 FDA report on PREA enforcement

Section 508(b) of the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 355c–1(b)) is amended—

(1)
in paragraph (11), by striking the semicolon at the end and inserting “, including an evaluation of compliance with deadlines provided for in deferrals and deferral extensions;”;
(2)
in paragraph (15), by striking “and” at the end;
(3)
in paragraph (16), by striking the period at the end and inserting “; and”; and
(4)
by adding at the end the following:

changed “(17) a listing of penalties, settlements, or payments under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) for failure to comply with requirements under such section 505B, including, for each penalty, settlement, or payment, the name of the drug, the sponsor thereof, and the amount of the penalty, settlement, or payment imposed; and”imposed.”

Sec. 7 Program for pediatric studies of drugs

changed Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 284m(d)(1)) is amended by striking “section,” and all that follows through the period at the end and inserting “section, $25,000,000 for each of fiscal years 2025 2026 through 2027.”.2028.”.

Sec. 9 Establishment of Abraham Accords Office within Food and Drug Administration

(a)
In general— Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:

“1015. Abraham Accords Office

“(a) In general—The Secretary, acting through the Commissioner of Food and Drugs, shall establish within the Food and Drug Administration an office, to be known as the Abraham Accords Office, to be headed by a director.

“(b) Office—Not later than two years after the date of enactment of this section, the Secretary shall—

“(1) in consultation with the governments of Abraham Accords countries, as well as appropriate United States Government diplomatic and security personnel—

“(A) select the location of the Abraham Accords Office in an Abraham Accords country; and

“(B) establish such office; and

“(2) assign to such office such personnel of the Food and Drug Administration as the Secretary determines necessary to carry out the functions of such office.

“(c) Duties—The Secretary, acting through the Director of the Abraham Accords Office, shall—

“(1) after the Abraham Accords Office is established—

“(A) as part of the Food and Drug Administration’s work to strengthen the international oversight of regulated commodities, provide technical assistance to regulatory partners in Abraham Accords countries on strengthening regulatory oversight and converging regulatory requirements for the oversight of regulated products, including good manufacturing practices and other issues relevant to manufacturing medical products that are regulated by the Food and Drug Administration; and

“(B) facilitate interactions between the Food and Drug Administration and interested parties in Abraham Accords countries, including by sharing relevant information regarding United States regulatory pathways with such parties, and facilitate feedback on the research, development, and manufacturing of products regulated in accordance with this Act; and

“(2) carry out other functions and activities as the Secretary determines to be necessary to carry out this section.

“(d) Abraham Accords country defined—In this section, the term Abraham Accords country means a country identified by the Department of State as having signed the Abraham Accords Declaration.

“(e) National security—Nothing in this section shall be construed to require any action inconsistent with a national security recommendation provided by the Federal Government.”

(b)
Report to Congress—
(1)
In general— Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Congress a report on the Abraham Accords Office, including—
(A)
an evaluation of how the Office has advanced progress toward conformance with Food and Drug Administration regulatory requirements by manufacturers in the Abraham Accords countries;
(B)
a numerical count of parties that the Office has helped facilitate interactions or feedback pursuant to section 1015(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a));
(C)
a summary of technical assistance provided to regulatory partners in Abraham Accords countries pursuant to subparagraph (A) of such section 1015(c)(1); and
(D)
recommendations for increasing and improving coordination between the Food and Drug Administration and entities in Abraham Accords countries.
(2)
changed Abraham Accords country defined— In this subsection, the term “Abraham Abraham Accords country” country has the meaning given such term in section 1015(d) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).

Sec. 10 Increasing transparency in generic drug applications

added
(a)
added In general— Section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the following:

added “(H)

added “(i) Upon request (in controlled correspondence or an analogous process) by a person that has submitted or intends to submit an abbreviated application under this subsection for a drug that is required by regulation to contain one or more of the same inactive ingredients in the same concentrations as the listed drug referred to, or for which the Secretary determines there is a scientific justification for an approach that is in vitro, in whole or in part, to be used to demonstrate bioequivalence for a drug if such a drug contains one or more of the same inactive ingredients in the same concentrations as the listed drug referred to, the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also provide such information to such a person on the Secretary’s own initiative during the review of an abbreviated application under this subsection for such drug.

added “(ii) Notwithstanding section 301(j), if the Secretary determines that such drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person—

added “(I) the ingredient or ingredients that cause such drug not to be qualitatively or quantitatively the same as the listed drug; and

added “(II) for any ingredient for which there is an identified quantitative deviation, the amount of such deviation.

added “(iii) If the Secretary determines that such drug is qualitatively and quantitatively the same as the listed drug, the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless—

added “(I) the formulation of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or

added “(II) the Secretary makes a written determination that the prior determination must be changed because an error has been identified.

added “(iv) If the Secretary makes a written determination described in clause (iii)(II), the Secretary shall provide notice and a copy of the written determination to the person making the request under clause (i).

added “(v) The disclosures authorized under clauses (i) and (ii) are disclosures authorized by law, including for purposes of section 1905 of title 18, United States Code. This subparagraph shall not otherwise be construed to authorize the disclosure of nonpublic qualitative or quantitative information about the ingredients in a listed drug, or to affect the status, if any, of such information as trade secret or confidential commercial information for purposes of section 301(j) of this Act, section 552 of title 5, United States Code, or section 1905 of title 18, United States Code.”

(b)
added Guidance—
(1)
added In general— Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance, or update guidance, describing how the Secretary will determine whether a drug is qualitatively and quantitatively the same as the listed drug (as such terms are used in section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)), including with respect to assessing pH adjusters.
(2)
added Process— In issuing guidance under this subsection, the Secretary of Health and Human Services shall—
(A)
added publish draft guidance;
(B)
added provide a period of at least 60 days for comment on the draft guidance; and
(C)
added after considering any comments received and not later than one year after the close of the comment period on the draft guidance, publish final guidance.
(c)
added Applicability— Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized.

Sec. 11 Medicare Improvement Fund

added

added Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended—

(1)
added by striking “fiscal year 2026” and inserting “fiscal year 2027”; and
(2)
added by striking “$1,804,000,000” and inserting “$3,047,000,000”.