Statements on Introduced Bills and Joint Resolutions
Floor Speech
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 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.
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.
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