[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.

                          ____________________