H.R. 1262

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1262 Engrossed in House (EH)]

<DOC>

119th CONGRESS
1st Session
H. R. 1262

_______________________________________________________________________

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act with respect to 
molecularly targeted pediatric cancer investigations, and for other 
purposes.

Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ``Mikaela Naylon 
Give Kids a Chance Act''.
(b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Research into pediatric uses of drugs; additional authorities 
of Food and Drug Administration regarding 
molecularly targeted cancer drugs.
Sec. 3. Ensuring completion of pediatric study requirements.
Sec. 4. FDA report on PREA enforcement.
Sec. 5. Extension of authority to issue priority review vouchers to 
encourage treatments for rare pediatric 
diseases.
Sec. 6. Limitations on exclusive approval or licensure of orphan drugs.
Sec. 7. Program for pediatric studies of drugs.
Sec. 8. Organ Procurement and Transplantation Network.
Sec. 9. Establishment of Abraham Accords Office within Food and Drug 
Administration.
Sec. 10. Increasing transparency in generic drug applications.
Sec. 11. Medicare Improvement Fund.

SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES 
OF FOOD AND DRUG ADMINISTRATION REGARDING MOLECULARLY 
TARGETED CANCER DRUGS.

(a) In General.--
(1) Additional active ingredient for application drug; 
limitation regarding novel-combination application drug.--
Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355c(a)(3)) is amended--
(A) by redesignating subparagraphs (B) and (C) as 
subparagraphs (C) and (D), respectively; and
(B) by striking subparagraph (A) and inserting the 
following:
``(A) In general.--For purposes of paragraph 
(1)(B), the investigation described in this paragraph 
is a molecularly targeted pediatric cancer 
investigation of--
``(i) the drug or biological product for 
which the application referred to in such 
paragraph is submitted; or
``(ii) such drug or biological product used 
in combination with--
``(I) an active ingredient of a 
drug or biological product--
``(aa) for which an 
approved application under 
section 505(j) under this Act 
or under section 351(k) of the 
Public Health Service Act is in 
effect; and
``(bb) that is determined 
by the Secretary, after 
consultation with the 
applicant, to be part of the 
standard of care for treating a 
pediatric cancer; or
``(II) an active ingredient of a 
drug or biological product--
``(aa) for which an 
approved application under 
section 505(b) of this Act or 
section 351(a) of the Public 
Health Service Act to treat an 
adult cancer is in effect and 
is held by the same person 
submitting the application 
under paragraph (1)(B); and
``(bb) that is directed at 
a molecular target that the 
Secretary determines to be 
substantially relevant to the 
growth or progression of a 
pediatric cancer.
``(B) Additional requirements.--
``(i) Design of investigation.--A 
molecularly targeted pediatric cancer 
investigation referred to in subparagraph (A) 
shall be designed to yield clinically 
meaningful pediatric study data that is 
gathered using appropriate formulations for 
each age group for which the study is required, 
regarding dosing, safety, and preliminary 
efficacy to inform potential pediatric 
labeling.
``(ii) Limitation.--An investigation 
described in subparagraph (A)(ii) may be 
required only if the drug or biological product 
for which the application referred to in 
paragraph (1)(B) contains either--
``(I) a single new active 
ingredient; or
``(II) more than one active 
ingredient, if an application for the 
combination of active ingredients has 
not previously been approved but each 
active ingredient is in a drug product 
that has been previously approved to 
treat an adult cancer.
``(iii) Results of already-completed 
preclinical studies of application drug.--With 
respect to an investigation required pursuant 
to paragraph (1)(B), the Secretary may require 
the results of any completed preclinical 
studies relevant to the initial pediatric study 
plan be submitted to the Secretary at the same 
time that the initial pediatric study plan 
required under subsection (e)(1) is submitted.
``(iv) Rule of construction regarding 
inactive ingredients.--With respect to a 
combination of active ingredients referred to 
in subparagraph (A)(ii), such subparagraph 
shall not be construed as addressing the use of 
inactive ingredients with such combination.''.
(2) Determination of applicable requirements.--Section 
505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c(e)(1)) is amended by adding at the end the 
following: ``The Secretary shall determine whether subparagraph 
(A) or (B) of subsection (a)(1) applies with respect to an 
application before the date on which the applicant is required 
to submit the initial pediatric study plan under paragraph 
(2)(A).''.
(3) Clarifying applicability.--Section 505B(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is 
amended by adding at the end the following:
``(C) Rule of construction.--No application that is 
subject to the requirements of subparagraph (B) shall 
be subject to the requirements of subparagraph (A), and 
no application (or supplement to an application) that 
is subject to the requirements of subparagraph (A) 
shall be subject to the requirements of subparagraph 
(B).''.
(4) Conforming amendments.--Section 505B(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
(A) in paragraph (3)(C), as redesignated by 
paragraph (1)(A) of this subsection, by striking 
``investigations described in this paragraph'' and 
inserting ``investigations referred to in subparagraph 
(A)''; and
(B) in paragraph (3)(D), as redesignated by 
paragraph (1)(A) of this subsection, by striking ``the 
assessments under paragraph (2)(B)'' and inserting 
``the assessments required under paragraph (1)(A)''.
(b) Guidance.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall--
(1) not later than 12 months after the date of enactment of 
this Act, issue draft guidance on the implementation of the 
amendments made by subsection (a); and
(2) not later than 12 months after closing the comment 
period on such draft guidance, finalize such guidance.
(c) Applicability.--The amendments made by this section apply with 
respect to any application under section 505(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(b)) and any application under 
section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), 
that is submitted on or after the date that is 3 years after the date 
of enactment of this Act.
(d) Reports to Congress.--
(1) Secretary of health and human services.--Not later than 
6 years after the date of enactment of this Act, the Secretary 
of Health and Human Services shall submit to the Committee on 
Energy and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of the 
Senate a report on the Secretary's efforts, in coordination 
with industry, to ensure implementation of the amendments made 
by subsection (a).
(2) GAO study and report.--
(A) Study.--Not later than 8 years after the date 
of enactment of this Act, the Comptroller General of 
the United States shall conduct a study of the 
effectiveness of requiring assessments and 
investigations described in section 505B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as 
amended by subsection (a), in the development of drugs 
and biological products for pediatric cancer 
indications, including consideration of any benefits 
to, or burdens on, pediatric cancer drug development.
(B) Findings.--Not later than 10 years after the 
date of enactment of this Act, the Comptroller General 
shall submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate a 
report containing the findings of the study conducted 
under subparagraph (A).

SEC. 3. ENSURING COMPLETION OF PEDIATRIC STUDY REQUIREMENTS.

(a) Equal Accountability for Pediatric Study Requirements.--Section 
505B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)) 
is amended--
(1) in paragraph (1), by striking ``Beginning 270'' and 
inserting ``Noncompliance letter.--Beginning 270'';
(2) in paragraph (2)--
(A) by striking ``The drug or'' and inserting 
``Effect of noncompliance.--The drug or''; and
(B) by striking ``(except that the drug or 
biological product shall not be subject to action under 
section 303)'' and inserting ``(except that the drug or 
biological product shall be subject to action under 
section 303 only if such person demonstrated a lack of 
due diligence in satisfying the applicable 
requirement)''; and
(3) by adding at the end the following:
``(3) Limitation.--The Secretary shall not issue 
enforcement actions under section 303 for failures under this 
subsection in the case of a drug or biological product that is 
no longer marketed.''.
(b) Due Diligence.--Section 505B(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355c(d)), as amended by subsection (a), is 
further amended by adding at the end the following:
``(4) Due diligence.--Before the Secretary may conclude 
that a person failed to submit or otherwise meet a requirement 
as described in the matter preceding paragraph (1), the 
Secretary shall--
``(A) issue a noncompliance letter pursuant to 
paragraph (1);
``(B) provide such person with a 45-day period 
beginning on the date of receipt of such noncompliance 
letter to respond in writing as set forth in such 
paragraph; and
``(C) after reviewing such written response, 
determine whether the person demonstrated a lack of due 
diligence in satisfying such requirement.''.
(c) Conforming Amendments.--Section 303(f)(4)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(4)(A)) is amended by 
striking ``or 505-1'' and inserting ``505-1, or 505B''.
(d) Transition Rule.--The Secretary of Health and Human Services 
may take enforcement action under section 303 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333) only for failures described in 
section 505B(d) of such Act (21 U.S.C. 355c(d)) that occur on or after 
the date that is 180 days after the date of enactment of this Act.

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:
``(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.''.

SEC. 5. EXTENSION OF AUTHORITY TO ISSUE PRIORITY REVIEW VOUCHERS TO 
ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES.

(a) Extension.--Paragraph (5) of section 529(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by 
striking ``December 20, 2024, unless'' and all that follows through the 
period at the end and inserting ``September 30, 2029.''.
(b) User Fee Payment.--Section 529(c)(4) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360ff(c)(4)) is amended by striking 
subparagraph (A) and inserting the following:
``(A) In general.--The priority review user fee 
required by this subsection shall be due upon the 
submission of a human drug application under section 
505(b)(1) or section 351(a) of the Public Health 
Service Act for which the priority review voucher is 
used. All other user fees associated with the human 
drug application shall be due as required by the 
Secretary or under applicable law.''.
(c) GAO Report on Effectiveness of Rare Pediatric Disease Priority 
Voucher Awards in Incentivizing Rare Pediatric Disease Drug 
Development.--
(1) GAO study.--
(A) Study.--The Comptroller General of the United 
States shall conduct a study of the effectiveness of 
awarding rare pediatric disease priority vouchers under 
section 529 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360ff), as amended by subsection (a), in the 
development of human drug products that treat or 
prevent rare pediatric diseases (as defined in such 
section 529).
(B) Contents of study.--In conducting the study 
under subparagraph (A), the Comptroller General shall 
examine the following:
(i) The indications for each drug or 
biological product that--
(I) is the subject of a rare 
pediatric disease product application 
(as defined in section 529 of the 
Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360ff)) for which a priority 
review voucher was awarded; and
(II) was approved under section 505 
of the Federal Food, Drug, and Cosmetic 
Act (42 U.S.C. 355) or licensed under 
section 351 of the Public Health 
Service Act (42 U.S.C. 262).
(ii) Whether, and to what extent, an unmet 
need related to the treatment or prevention of 
a rare pediatric disease was met through the 
approval or licensure of such a drug or 
biological product.
(iii) The size of the company to which a 
priority review voucher was awarded under 
section 529 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360ff) for such a drug 
or biological product.
(iv) The value of such priority review 
voucher if transferred.
(v) Identification of each drug for which a 
priority review voucher awarded under such 
section 529 was used.
(vi) The size of the company using each 
priority review voucher awarded under such 
section 529.
(vii) The length of the period of time 
between the date on which a priority review 
voucher was awarded under such section 529 and 
the date on which it was used.
(viii) Whether, and to what extent, an 
unmet need related to the treatment or 
prevention of a rare pediatric disease was met 
through the approval under section 505 of the 
Federal Food, Drug, and Cosmetic Act (42 U.S.C. 
355) or licensure under section 351 of the 
Public Health Service Act (42 U.S.C. 262) of a 
drug for which a priority review voucher was 
used.
(ix) Whether, and to what extent, companies 
were motivated by the availability of priority 
review vouchers under section 529 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff) to attempt to develop a drug for a rare 
pediatric disease.
(x) Whether, and to what extent, pediatric 
review vouchers awarded under such section were 
successful in stimulating development and 
expedited patient access to drug products for 
treatment or prevention of a rare pediatric 
disease that wouldn't otherwise take place 
without the incentive provided by such 
vouchers.
(xi) The impact of such priority review 
vouchers on the workload, review process, and 
public health prioritization efforts of the 
Food and Drug Administration.
(xii) Any other incentives in Federal law 
that exist for companies developing drugs or 
biological products described in clause (i).
(2) Report on findings.--Not later than 5 years after the 
date of the enactment of this Act, the Comptroller General of 
the United States shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate a report 
containing the findings of the study conducted under paragraph 
(1).

SEC. 6. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICENSURE OF ORPHAN DRUGS.

(a) In General.--Section 527 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360cc) is amended--
(1) in subsection (a), in the matter following paragraph 
(2), by striking ``same disease or condition'' and inserting 
``same approved use or indication within such rare disease or 
condition'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by 
striking ``same rare disease or condition'' and 
inserting ``same approved use or indication for which 
such 7-year period applies to such already approved or 
licensed drug''; and
(B) in paragraph (1), by inserting ``, relating to 
the approved use or indication,'' after ``the needs'';
(3) in subsection (c)(1), by striking ``same rare disease 
or condition as the already approved drug'' and inserting 
``same use or indication for which the already approved or 
licensed drug was approved or licensed''; and
(4) by adding at the end the following:
``(f) Approved Use or Indication Defined.--In this section, the 
term `approved use or indication' means the use or indication approved 
under section 505 of this Act or licensed under section 351 of the 
Public Health Service Act for a drug designated under section 526 for a 
rare disease or condition.''.
(b) Application of Amendments.--The amendments made by subsection 
(a) shall apply with respect to any drug designated under section 526 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), 
regardless of the date on which the drug was so designated, and 
regardless of the date on which the drug was approved under section 505 
of such Act (21 U.S.C. 355) or licensed under section 351 of the Public 
Health Service Act (42 U.S.C. 262).

SEC. 7. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

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 2026 through 2028.''.

SEC. 8. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

Section 372 of the Public Health Service Act (42 U.S.C. 274) is 
amended--
(1) in subsection (b)(2)--
(A) by moving the margins of subparagraphs (M) 
through (O) 2 ems to the left;
(B) in subparagraph (A)--
(i) in clause (i), by striking ``, and'' 
and inserting ``; and''; and
(ii) in clause (ii), by striking the comma 
at the end and inserting a semicolon;
(C) in subparagraph (C), by striking ``twenty-four-
hour telephone service'' and inserting ``24-hour 
telephone or information technology service'';
(D) in each of subparagraphs (B) through (M), by 
striking the comma at the end and inserting a 
semicolon;
(E) in subparagraph (N), by striking 
``transportation, and'' and inserting 
``transportation;'';
(F) in subparagraph (O), by striking the period and 
inserting a semicolon; and
(G) by adding at the end the following:
``(P) encourage the integration of electronic 
health records systems through application programming 
interfaces (or successor technologies) among hospitals, 
organ procurement organizations, and transplant 
centers, including the use of automated electronic 
hospital referrals and the grant of remote, electronic 
access to hospital electronic health records of 
potential donors by organ procurement organizations, in 
a manner that complies with the privacy regulations 
promulgated under the Health Insurance Portability and 
Accountability Act of 1996, at part 160 of title 45, 
Code of Federal Regulations, and subparts A, C, and E 
of part 164 of such title (or any successor 
regulations); and
``(Q) consider establishing a dashboard to display 
the number of transplants performed, the types of 
transplants performed, the number and types of organs 
that entered the Organ Procurement and Transplantation 
Network system and failed to be transplanted, and other 
appropriate statistics, which should be updated more 
frequently than annually.''; and
(2) by adding at the end the following:
``(d) Registration Fees.--
``(1) In general.--The Secretary may collect registration 
fees from any member of the Organ Procurement and 
Transplantation Network for each transplant candidate such 
member places on the list described in subsection (b)(2)(A)(i). 
Such registration fees shall be collected and distributed only 
to support the operation of the Organ Procurement and 
Transplantation Network. Such registration fees are authorized 
to remain available until expended.
``(2) Collection.--The Secretary may collect the 
registration fees under paragraph (1) directly or through 
awards made under subsection (b)(1)(A).
``(3) Distribution.--Any amounts collected under this 
subsection shall--
``(A) be credited to the currently applicable 
appropriation, account, or fund of the Department of 
Health and Human Services as discretionary offsetting 
collections; and
``(B) be available, only to the extent and in the 
amounts provided in advance in appropriations Acts, to 
distribute such fees among awardees described in 
subsection (b)(1)(A).
``(4) Transparency.--The Secretary shall--
``(A) promptly post on the website of the Organ 
Procurement and Transplantation Network--
``(i) the amount of registration fees 
collected under this subsection from each 
member of the Organ Procurement and 
Transplantation Network; and
``(ii) a list of activities such fees are 
used to support; and
``(B) update the information posted pursuant to 
subparagraph (A), as applicable for each calendar 
quarter for which fees are collected under paragraph 
(1).
``(5) GAO review.--Not later than 2 years after the date of 
enactment of this subsection, the Comptroller General of the 
United States shall, to the extent data are available--
``(A) conduct a review concerning the activities 
under this subsection; and
``(B) submit to the Committee on Health, Education, 
Labor, and Pensions and the Committee on Finance of the 
Senate and the Committee on Energy and Commerce of the 
House of Representatives, a report on such review, 
including related recommendations, as applicable.
``(6) Sunset.--The authority to collect registration fees 
under paragraph (1) shall expire on the date that is 3 years 
after the date of enactment of the Mikaela Naylon Give Kids a 
Chance Act.''.

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:

``SEC. 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) Abraham accords country defined.--In this subsection, 
the term ``Abraham Accords 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.

(a) 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:
``(H)(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.
``(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--
``(I) the ingredient or ingredients that cause such drug 
not to be qualitatively or quantitatively the same as the 
listed drug; and
``(II) for any ingredient for which there is an identified 
quantitative deviation, the amount of such deviation.
``(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--
``(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
``(II) the Secretary makes a written determination that the 
prior determination must be changed because an error has been 
identified.
``(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).
``(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) Guidance.--
(1) 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) Process.--In issuing guidance under this subsection, 
the Secretary of Health and Human Services shall--
(A) publish draft guidance;
(B) provide a period of at least 60 days for 
comment on the draft guidance; and
(C) 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) 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.

Section 1898(b)(1) of the Social Security Act (42 U.S.C. 
1395iii(b)(1)) is amended by striking ``$1,403,000,000'' and inserting 
``$2,622,000,000''.

Passed the House of Representatives December 1, 2025.

Attest:

Clerk.
119th CONGRESS

1st Session

H. R. 1262

_______________________________________________________________________

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act with respect to 
molecularly targeted pediatric cancer investigations, and for other 
purposes.