[Congressional Record Volume 170, Number 125 (Wednesday, July 31, 2024)]
[Senate]
[Pages S5684-S5686]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. DURBIN (for himself and Mr. Cassidy):
S. 4878. A bill to amend the Federal Food, Drug, and Cosmetic Act
with respect to approval of abbreviated new drug applications; to the
Committee on Health, Education, Labor, and Pensions.
Mr. DURBIN. Madam President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 4878
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Reforming Evergreening and
Manipulation that Extends Drug Years Act'' or the ``REMEDY
Act''.
SEC. 2. AMENDMENTS TO ANDA APPROVAL PROVISIONS.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) is amended--
(1) in subsection (c)(2) by adding at the end the
following: ``With respect to a drug approved on or after the
date of enactment of the Reforming Evergreening and
Manipulation that Extends Drug Years Act, when a holder of an
approved application first files information under this
paragraph with respect to one or more patents described in
subsection (b)(1)(A)(viii), the holder shall select one such
patent with respect to which the owner or licensee may
receive the 30-month stay under paragraph (3)(C), as
applicable; for purposes of paragraphs (3)(C) and (3)(E) and
subsections (j)(5)(D)(iii) and (j)(5)(F)(ii), such patent
shall be referred to as the `covered patent'. The selection
of such covered patent may not be changed or amended.'';
(2) in subsection (c)(3)(C)--
(A) in the matter preceding clause (i)--
(i) by striking ``an action is brought for infringement''
and all that follows through the period at the end of the
first sentence and inserting ``with respect to a drug
approved under this subsection before the date of enactment
of the Reforming Evergreening and Manipulation that Extends
Drug Years Act, an action is brought for infringement of any
patent that is the subject of the certification and for which
information was submitted to the Secretary under paragraph
(2) or subsection (b)(1) before the date on which the
application (excluding an amendment or supplement to the
application) was submitted, or, with respect to a drug
approved under this subsection on or after the date of
enactment of the Reforming Evergreening and Manipulation that
Extends Drug Years Act, an action is brought for infringement
of the covered patent (as described in paragraph (2)), before
the date on which the application (excluding an amendment or
supplement to the application) was submitted.''; and
(ii) by striking ``an action is brought before'' and
inserting ``an action with respect to a patent or a covered
patent, as applicable, is brought before''; and
(B) in clause (i), by striking ``decides that the patent''
and inserting ``decides that the patent or the covered
patent, as applicable'';
(3) in the second sentence of subsection (c)(3)(E)(ii), by
inserting ``with respect to any patent that claims a drug
that was approved under this subsection before the date of
enactment of the Reforming Evergreening and Manipulation that
Extends Drug Years Act, or, with respect to a covered patent
(as described in paragraph (2)) that claims a drug approved
under this subsection on or after the date of enactment of
such Act,'' after ``action for patent infringement'';
(4) in subsection (j)(5)(B)(iii)--
(A) in the matter preceding subclause (I)--
(i) by striking ``an action is brought for infringement''
and all that follows through the period at the end of the
first sentence and inserting ``with respect to a drug
approved under subsection (c) before the date of enactment of
the Reforming Evergreening and Manipulation that Extends Drug
Years Act, an action is brought for infringement of any
[[Page S5685]]
patent that is the subject of the certification and for which
information was submitted to the Secretary under subsection
(b)(1) or (c)(2) before the date on which the application
(excluding an amendment or supplement to the application),
which the Secretary later determines to be substantially
complete, was submitted, or, with respect to a drug approved
under subsection (c) on or after the date of enactment of the
Reforming Evergreening and Manipulation that Extends Drug
Years Act, an action is brought for infringement of the
covered patent (as described in subsection (c)(2)) before the
date on which the application (excluding an amendment or
supplement to the application), which the Secretary later
determines to be substantially complete, was submitted.'';
and
(ii) by striking ``an action is brought before'' and
inserting ``an action with respect to a patent or a covered
patent, as applicable, is brought before''; and
(B) in subclause (I), by striking ``decides that the
patent'' and inserting ``decides that the patent or covered
patent, as applicable,''; and
(5) in the second sentence of subsection (j)(5)(F)(ii), by
inserting ``with respect to any patent that claims a drug
that was approved under subsection (c) before the date of
enactment of the Reforming Evergreening and Manipulation that
Extends Drug Years Act, or, with respect to a covered patent
(as described in subsection (c)(2)) that claims a drug
approved under subsection (c) on or after the date of
enactment of such Act,'' after ``action for patent
infringement''.
______
By Mr. DURBIN (for himself, Mr. Blumenthal, Mr. Van Hollen, and
Mr. Brown):
S. 4879. A bill to prioritize funding for an expanded and sustained
national investment in biomedical research; to the Committee on
Appropriations.
Mr. DURBIN. Madam President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 4879
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``American Cures Act''.
SEC. 2. APPROPRIATIONS FOR INNOVATION.
(a) In General.--There are hereby authorized to be
appropriated, and appropriated, out of any monies in the
Treasury not otherwise appropriated, the following:
(1) National institutes of health.--For the National
Institutes of Health at the Department of Health and Human
Services--
(A) for fiscal year 2025, $52,468,000,000;
(B) for fiscal year 2026, $56,665,000,000;
(C) for fiscal year 2027, $61,198,000,000;
(D) for fiscal year 2028, $66,094,000,000;
(E) for fiscal year 2029, $71,382,000,000;
(F) for fiscal year 2030, $77,093,000,000;
(G) for fiscal year 2031, $83,260,000,000;
(H) for fiscal year 2032, $89,921,000,000;
(I) for fiscal year 2033, $97,115,000,000;
(J) for fiscal year 2034, $104,884,000,000; and
(K) for fiscal year 2035 and each fiscal year thereafter,
the amount appropriated under this paragraph for the previous
fiscal year, increased by the percentage increase (if any),
during the previous fiscal year, in the Consumer Price Index
for all urban consumers published by the Bureau of Labor
Statistics.
(2) Centers for disease control and prevention.--For the
Centers for Disease Control and Prevention at the Department
of Health and Human Services--
(A) for fiscal year 2025, $9,960,000,000;
(B) for fiscal year 2026, $10,757,000,000;
(C) for fiscal year 2027, $11,618,000,000;
(D) for fiscal year 2028, $12,547,000,000;
(E) for fiscal year 2029, $13,551,000,000;
(F) for fiscal year 2030, $14,635,000,000;
(G) for fiscal year 2031, $15,806,000,000;
(H) for fiscal year 2032, $17,070,000,000;
(I) for fiscal year 2033, $18,436,000,000;
(J) for fiscal year 2034, $19,911,000,000; and
(K) for fiscal year 2035 and each fiscal year thereafter,
the amount appropriated under this paragraph for the previous
fiscal year, increased by the percentage increase (if any),
during the previous fiscal year, in the Consumer Price Index
for all urban consumers published by the Bureau of Labor
Statistics.
(3) Research, development, test, and evaluation program of
the department of defense health program.--For the research,
development, test, and evaluation program of the Department
of Defense health program--
(A) for fiscal year 2025, $3,550,000,000;
(B) for fiscal year 2026, $3,834,000,000;
(C) for fiscal year 2027, $4,141,000,000;
(D) for fiscal year 2028, $4,472,000,000;
(E) for fiscal year 2029, $4,830,000,000;
(F) for fiscal year 2030, $5,216,000,000;
(G) for fiscal year 2031, $5,633,000,000;
(H) for fiscal year 2032, $6,084,000,000;
(I) for fiscal year 2033, $6,571,000,000;
(J) for fiscal year 2034, $7,096,000,000; and
(K) for fiscal year 2035 and each fiscal year thereafter,
the amount appropriated under this paragraph for the previous
fiscal year, increased by the percentage increase (if any),
during the previous fiscal year, in the Consumer Price Index
for all urban consumers published by the Bureau of Labor
Statistics.
(4) Medical and prosthetics research program of the
department of veterans affairs.--For the medical and
prosthetics research program of the Department of Veterans
Affairs--
(A) for fiscal year 2025, $1,018,000,000;
(B) for fiscal year 2026, $1,099,000,000;
(C) for fiscal year 2027, $1,187,000,000;
(D) for fiscal year 2028, $1,282,000,000;
(E) for fiscal year 2029, $1,385,000,000;
(F) for fiscal year 2030, $1,496,000,000;
(G) for fiscal year 2031, $1,616,000,000;
(H) for fiscal year 2032, $1,745,000,000;
(I) for fiscal year 2033, $1,885,000,000;
(J) for fiscal year 2034, $2,035,000,000; and
(K) for fiscal year 2035 and each fiscal year thereafter,
the amount appropriated under this paragraph for the previous
fiscal year, increased by the percentage increase (if any),
during the previous fiscal year, in the Consumer Price Index
for all urban consumers published by the Bureau of Labor
Statistics.
(b) Availability.--Amounts appropriated under subsection
(a) shall remain available until expended.
(c) Definitions.--In this section:
(1) Centers for disease control and prevention.--The term
``Centers for Disease Control and Prevention'' means the
appropriations accounts that support the various institutes,
offices, and centers that make up the Centers for Disease
Control and Prevention.
(2) Research, development, test, and evaluation program of
the department of defense health program.--The term
``research, development, test, and evaluation program of the
Department of Defense health program'' means the
appropriations accounts that support the various institutes,
offices, and centers that make up the research, development,
test, and evaluation program of the Department of Defense
health program.
(3) Medical and prosthetics research program of the
department of veterans affairs.--The term ``medical and
prosthetics research program of the Department of Veterans
Affairs'' means the appropriations accounts that support the
various institutes, offices, and centers that make up the
medical and prosthetics research program of the Department of
Veterans Affairs.
(4) National institutes of health.--The term ``National
Institutes of Health'' means the appropriations accounts that
support the various institutes, offices, and centers that
make up the National Institutes of Health.
(d) Exemption of Certain Appropriations From
Sequestration.--
(1) In general.--Section 255(g)(1)(A) of the Balanced
Budget and Emergency Deficit Control Act (2 U.S.C.
905(g)(1)(A)) is amended by inserting after ``Advances to the
Unemployment Trust Fund and Other Funds (16-0327-0-1-600).''
the following:
``Appropriations under the American Cures Act.''.
(2) Applicability.--The amendment made by this section
shall apply to any sequestration order issued under the
Balanced Budget and Emergency Deficit Control Act of 1985 (2
U.S.C. 900 et seq.) on or after the date of enactment of this
Act.
(e) Budgetary Effects.--
(1) Statutory paygo scorecards.--The budgetary effects of
this section shall not be entered on either PAYGO scorecard
maintained pursuant to section 4(d) of the Statutory Pay-As-
You-Go Act of 2010 (2 U.S.C. 933(d)).
(2) Senate paygo scorecards.--The budgetary effects of this
section shall not be entered on any PAYGO scorecard
maintained for purposes of section 4106 of H. Con. Res. 71
(115th Congress).
______
By Mr. REED (for himself and Mrs. Capito):
S. 4905. A bill to amend the Federal Food, Drug, and Cosmetic Act
with respect to molecularly targeted pediatric cancer investigations,
and for other purposes; to the Committee on Health, Education, Labor,
and Pensions.
Mr. REED. Madam President, today, I am joining Senator Capito to
introduce the Innovation in Pediatric Drugs Act of 2024 in order to
improve access to needed therapies for children.
Children are not just small adults. Drugs affect their developing
bodies differently, so new treatments need to be studied carefully to
ensure that they are appropriately prescribed and that dosages are
properly adjusted. Additionally, drugs that are designed to treat a
specific condition in adults may have enormous benefits in treating
completely different illnesses in kids, but research is needed to
unlock these potentially lifesaving possibilities.
Unfortunately, drug development still leaves children behind. The
legislation we are introducing today would help speed therapies to
children who need them by making needed changes to the Best
Pharmaceuticals for Children Act BPCA, and the Pediatric Research
Equity Act, PREA--two laws that encourage and require the study of
drugs in children.
Data resulting from BPCA and PREA studies are added to drug labels to
give parents and providers essential information on the safety and
efficacy of drugs used in children. I was proud to have helped author
these laws when I
[[Page S5686]]
was a member of the Health, Education, Labor, and Pensions Committee.
While we have made tremendous progress in advancing treatments for
children because of these laws, there are gaps. For example, there is a
loophole in PREA that exempts drug companies from pediatric study
requirements when the treatment would only be used for a rare pediatric
condition.
There are close to 7,000 rare diseases without appropriate
treatments, and the vast majority of these diseases affect children as
well as adults. But in developing new drugs also known as orphan drugs
to treat rare diseases, pharmaceutical developers focus their research
on adult patients only since they are not required study their impact
on children.
And since the majority of new drugs approved by the Food and Drug
Administration, FDA are orphan drugs, this means that the majority of
newly approved drugs have not been studied for their impacts on kids.
This leaves doctors, parents, and sick kids in the dark about the best
possible treatments. Our bill closes this loophole to require studies
for children so that they, too, can benefit from new and innovative
treatments for rare diseases.
In addition to this change, the Innovation in Pediatric Drugs Act
would invest in pediatric studies of older, off-patent drugs. The FDA
incentives and requirements under BPCA and PREA work for many newer
drugs but unfortunately cannot help encourage studies of older drugs.
For this reason, in 2002, Congress authorized a program which funds the
National Institutes of Health to conduct studies of off-patent drugs
used in children that would never be completed otherwise. Drug studies
are expensive, and costs have only increased since then, but the
program has been flat-funded at $25 million since it was created more
than 20 years ago. Our legislation would increase the authorization for
the BPCA NIH program to ensure we have better data about older drugs to
treat diseases in children.
Lastly, the Innovation in Pediatric Drugs Act would give FDA the
authority it needs to ensure that legally required pediatric studies
are completed in a timely manner. Due dates for studies required by
PREA are typically deferred by FDA until after the approval of the drug
for adults, but, FDA has no effective enforcement tools to ensure that
these studies are completed on time--or at all.
I am pleased to be working with my colleague Senator Capito on
pediatric health issues. We have worked closely for many years on
pediatric cancer, first authoring the Childhood Cancer Survivorship,
Treatment, Access, and Research, STAR Act in 2015. That bill was signed
into law in 2018, and we worked to fully fund the law every year since.
I look forward to working with her as well as the sponsors of the
House companion legislation, Representatives Anna Eshoo and Michael
McCaul to move the Innovation in Pediatric Drugs Act forward, to give
children and their families more options for treatments.
____________________