II 

118TH CONGRESS 

1ST SESSION S. 2683 

To establish requirements for purchasing certain generic drugs from 

manufacturers who produce the drug domestically. 

IN THE SENATE OF THE UNITED STATES 

JULY 27, 2023 

Mr. SCOTT of Florida introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To establish requirements for purchasing certain generic 

drugs from manufacturers who produce the drug domestically. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Accelerating Movement 

5 of Essential Rx Items to Create Access to National Drug 

6 Resources for US Government Services Act’’ or the 

7 ‘‘AMERICAN DRUGS Act’’. 

8 SEC. 2. FDA NOTIFICATION. 

9 (a) IN GENERAL.—The Secretary of Health and 

10 Human Services, acting through the Commissioner of 


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1 Food and Drugs (referred to in this section as the ‘‘Com2 missioner’’), shall issue notifications to the Administrator 

3 of the Centers for Medicare & Medicaid Services, the Sec4 retary of Defense, and the Secretary of Veterans Affairs 

5 upon a determination by the Commissioner that— 

6 (1) there are at least 2 approved generic drugs 

7 that are manufactured domestically, as described in 

8 subsection (b), each of which— 

9 (A) is approved pursuant to an application 

10 under section 505(j) of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 355(j)); 

12 and 

13 (B) references the same listed drug under 

14 paragraph (7) of such section 505(j); or 

15 (2) there are fewer than 2 approved generic 

16 drugs that are manufactured domestically— 

17 (A) approved pursuant to an application 

18 under section 505(j) of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 355(j)); 

20 and 

21 (B) that reference the same listed drug 

22 under paragraph (7) of such section 505(j) as 

23 another drug approved under such section 

24 505(j); 


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1 (3) paragraph (1)(B) may soon apply because 

2 the Commissioner has been notified that a holder of 

3 an approved application for a generic drug that is 

4 manufactured domestically, as described in sub5 section (b), plans to discontinue manufacturing, or 

6 expects an interruption of the manufacture of, such 

7 drug at an establishment described in subsection 

8 (b)(1)(B); or 

9 (4) a generic drug that is manufactured domes10 tically, as described in subsection (b), is in shortage, 

11 as defined in section 506C(h)(2) of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 

13 356c(h)(2)). 

14 (b) GENERIC DRUG MANUFACTURED DOMESTICALLY

15 DESCRIBED.—In this section, a generic drug that is man16 ufactured domestically— 

17 (1) is a drug— 

18 (A) that is approved under section 505(j) 

19 of the Federal Food, Drug, and Cosmetic Act 

20 (21 U.S.C. 355(j)); and 

21 (B) for which there is at least one estab22 lishment registered under section 510(b)(1) of 

23 the Federal Food, Drug, and Cosmetic Act (21 

24 U.S.C. 360(b)(1)) engaged in the manufacture 

25 of the finished dosage form of the drug; and 


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1 (2) excludes any authorized generic drug, as de2 fined in section 505(t)(3) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 355(t)(3)). 

4 (c) SPECIAL RULE CONCERNING GENERIC DRUGS IN

5 SHORTAGE.—A notification under subsection (a)(4) that 

6 a generic drug that is manufactured domestically, as de7 scribed in subsection (b), is in shortage, shall apply only 

8 for— 

9 (1) an initial period of not more than 90 days; 

10 and 

11 (2) such additional 30-day renewal periods as 

12 the Secretary of Health and Human Services may 

13 indicate by— 

14 (A) submitting to Congress a notification 

15 of intent to renew the notification under sub16 section (a)(4); and 

17 (B) publicly posting information about the 

18 shortage, the steps the Food and Drug Admin19 istration is taking to address the shortage, and 

20 an estimated date by which the shortage is ex21 pected to be resolved. 


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1 SEC. 3. EXPEDITED CONSIDERATION OF CERTAIN ABBRE2 VIATED NEW DRUG APPLICATIONS. 

3 Chapter V of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

5 section 506L the following: 

6 ‘‘SEC. 506M. EXPEDITED CONSIDERATION OF CERTAIN AB7 BREVIATED NEW DRUG APPLICATIONS. 

8 ‘‘(a) IN GENERAL.—The Secretary may, at the re9 quest of a sponsor of an application for an applicable drug, 

10 expedite the development and review of an abbreviated 

11 new drug application under section 505(j) for such drug. 

12 ‘‘(b) APPLICABLE DRUG.—For purposes of this sec13 tion, an applicable drug is a drug for which there are fewer 

14 than 2 drugs approved under section 505(j) that are man15 ufactured domestically, as described in paragraph (2), 

16 each of which is approved pursuant to an application 

17 under section 505(j) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 355(j)) and references the same list19 ed drug under paragraph (7) of such section 505(j). 

20 ‘‘(c) ACTIONS.—In expediting the development and 

21 review of an application under subsection (a), the Sec22 retary may, as requested by the applicant, take actions 

23 including the following: 

24 ‘‘(1) Hold meetings with the applicant and the 

25 review team throughout the development of the drug 


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1 prior to submission of the application for such drug 

2 under section 505(j). 

3 ‘‘(2) Provide timely advice to, and interactive 

4 communication with, the applicant regarding the de5 velopment of the drug to ensure that the develop6 ment program to gather the data necessary for ap7 proval is as efficient as practicable. 

8 ‘‘(3) Involve senior managers and experienced 

9 review staff, as appropriate, in a collaborative, co10 ordinated review of such application, including with 

11 respect to drug-device combination products and 

12 other complex products. 

13 ‘‘(4) Assign a cross-disciplinary project lead— 

14 ‘‘(A) to facilitate an efficient review of the 

15 development program and application, including 

16 manufacturing inspections; and 

17 ‘‘(B) to serve as a scientific liaison between 

18 the review team and the applicant. 

19 ‘‘(d) REPORTING REQUIREMENT.—Not later than 

20 one year after the date of the approval of an application 

21 under section 505(j) with respect to a drug for which the 

22 development and review is expedited under this section, 

23 the sponsor of such drug shall report to the Secretary on 

24 whether the drug has been marketed in interstate com25 merce since the date of such approval.’’. 


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1 SEC. 4. PROHIBITION OF PAYMENT UNDER MEDICARE 

2 PART B OR COVERAGE UNDER MEDICARE 

3 PART D FOR CERTAIN GENERIC DRUGS MAN4 UFACTURED OUTSIDE OF THE UNITED 

5 STATES. 

6 (a) MEDICARE PART B.—Section 1842(o) of the So7 cial Security Act (42 U.S.C. 1395u(o)) is amended by add8 ing at the end the following new paragraph: 

9 ‘‘(9)(A) Payment shall only be made under this part 

10 for a generic drug furnished on or after January 1, 2025, 

11 if it is a generic drug manufactured domestically (as de12 scribed in section 2(b) of the Accelerating Movement of 

13 Essential Rx Items to Create Access to National Drug Re14 sources for U.S. Government Services Act). 

15 ‘‘(B) Subparagraph (A) shall not apply, with respect 

16 to a drug, during any period for which the Secretary— 

17 ‘‘(i) has notified the Administrator of the Cen18 ters for Medicare & Medicaid Services pursuant to 

19 section 2(a) of the Accelerating Movement of Essen20 tial Rx Items to Create Access to National Drug Re21 sources for U.S. Government Services Act that the 

22 circumstances under paragraph (2), (3), or (4) of 

23 such section apply; or 

24 ‘‘(ii) otherwise determines that access to the 

25 drug is essential to the health of beneficiaries under 

26 this part.’’. 


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1 (b) MEDICARE PART D.—Section 1860D–42 of the 

2 Social Security Act (42 U.S.C. 1395w–152) is amended 

3 by adding at the end the following new subsection: 

4 ‘‘(e) PROHIBITION OF COVERAGE FOR CERTAIN GE5 NERIC DRUGS MANUFACTURED OUTSIDE OF THE UNITED

6 STATES.— 

7 ‘‘(1) IN GENERAL.—Coverage shall only be 

8 available under this part for a covered part D drug 

9 that is a generic drug dispensed on or after January 

10 1, 2025, if it is a generic drug manufactured domes11 tically (as described in section 2(b) of the Accel12 erating Movement of Essential Rx Items to Create 

13 Access to National Drug Resources for U.S. Govern14 ment Services Act). 

15 ‘‘(2) EXCEPTIONS.—Paragraph (1) shall not 

16 apply, with respect to a covered part D drug, during 

17 any period for which the Secretary— 

18 ‘‘(A) has notified the Administrator of the 

19 Centers for Medicare & Medicaid Services pur20 suant to section 2(a) of the Accelerating Move21 ment of Essential Rx Items to Create Access to 

22 National Drug Resources for U.S. Government 

23 Services Act that the circumstances under para24 graph (2), (3), or (4) of such section apply; or 


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1 ‘‘(B) otherwise determines that access to 

2 the drug is essential to the health of bene3 ficiaries under this part.’’. 

4 SEC. 5. PROHIBITION OF PAYMENT UNDER MEDICAID AND 

5 CHIP FOR CERTAIN GENERIC DRUGS MANU6 FACTURED OUTSIDE OF THE UNITED STATES. 

7 (a) MEDICAID.—Title XIX of the Social Security Act 

8 (42 U.S.C. 1396 et seq.) is amended— 

9 (1) in section 1903(i)(10)— 

10 (A) in subparagraph (D), by striking ‘‘; 

11 and’’ and inserting a semicolon; 

12 (B) in subparagraph (E), by striking ‘‘; 

13 or’’ and inserting ‘‘; and’’; and 

14 (C) by inserting after subparagraph (E) 

15 the following new subparagraph: 

16 ‘‘(F) with respect to any amount expended for 

17 a covered outpatient drug which the State is re18 quired to exclude from coverage under section 

19 1927(d)(8); or’’; and 

20 (2) in section 1927(d), by adding at the end the 

21 following new paragraph: 

22 ‘‘(8) RESTRICTION ON COVERAGE OF FOREIGN23 MADE GENERIC DRUGS.— 

24 ‘‘(A) IN GENERAL.—Beginning January 1, 

25 2025, a State shall exclude coverage of a forVerDate Sep 11 2014 04:38 Aug 17, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2683.IS S2683

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1 eign-made generic covered outpatient drug if 

2 there is a generic drug that is manufactured 

3 domestically (as described in section 2(b) of the 

4 Accelerating Movement of Essential Rx Items 

5 to Create Access to National Drug Resources 

6 for U.S. Government Services Act) that ref7 erences the same listed drug under section 

8 505(j)(7) of the Federal Food, Drug, and Cos9 metic Act as the foreign-made generic covered 

10 outpatient drug. 

11 ‘‘(B) DEFINITION OF FOREIGN-MADE GE12 NERIC COVERED OUTPATIENT DRUG.—For pur13 poses of this paragraph, the term ‘foreign-made 

14 generic covered outpatient drug’ means a cov15 ered outpatient drug that— 

16 ‘‘(i) is approved under section 505(j) 

17 of the Federal Food, Drug, and Cosmetic 

18 Act; and 

19 ‘‘(ii) is not a generic drug that is 

20 manufactured domestically (as described in 

21 section 2(b) of the Accelerating Movement 

22 of Essential Rx Items to Create Access to 

23 National Drug Resources for U.S. Govern24 ment Services Act). 


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1 ‘‘(C) EXCEPTIONS.—Subparagraph (A) 

2 shall not apply to a foreign-made generic cov3 ered outpatient drug during any period for 

4 which the Secretary— 

5 ‘‘(i) has notified the Administrator of 

6 the Centers for Medicare & Medicaid Serv7 ices pursuant to section 2(a) of the Accel8 erating Movement of Essential Rx Items to 

9 Create Access to National Drug Resources 

10 for U.S. Government Services Act that the 

11 circumstances under paragraph (2), (3), or 

12 (4) of such section apply with respect to 

13 such drug; or 

14 ‘‘(ii) otherwise determines that access 

15 to the foreign-made generic covered out16 patient drug is essential to the health of 

17 individuals enrolled for medical assistance 

18 under this title. 

19 ‘‘(D) NOTICE TO STATES.—The Secretary 

20 shall provide notice to States if a foreign-made 

21 generic covered outpatient drug is subject to ex22 clusion from coverage under this paragraph.’’. 

23 (b) CHIP.—Section 2107(e)(1)(M) of the Social Se24 curity Act (42 U.S.C. 1397gg(e)(1)(M)) is amended by in25 serting ‘‘(10)(F),’’ after ‘‘(2),’’. 


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1 SEC. 6. PROCUREMENT BY DEPARTMENT OF VETERANS AF2 FAIRS OF GENERIC DRUGS MANUFACTURED 

3 DOMESTICALLY. 

4 (a) IN GENERAL.—Subchapter II of chapter 81 of 

5 title 38, United States Code, is amended by inserting after 

6 section 8126 the following new section: 

7 ‘‘§ 8126A. Procurement of generic drugs manufac8 tured domestically 

9 ‘‘(a) IN GENERAL.—Subject to subsection (b), the 

10 Secretary may only procure a generic drug if it is a generic 

11 drug manufactured domestically, as described in section 

12 2(b) of the Accelerating Movement of Essential Rx Items 

13 to Create Access to National Drug Resources for U.S. 

14 Government Services Act. 

15 ‘‘(b) EXCEPTIONS.—Subsection (a) shall not apply 

16 with respect to a drug during any period for which— 

17 ‘‘(1) the Secretary of Health and Human Serv18 ices has notified the Secretary of Veterans Affairs 

19 pursuant to section 2(a) of the Accelerating Move20 ment of Essential Rx Items to Create Access to Na21 tional Drug Resources for U.S. Government Services 

22 Act that the circumstances under paragraph (2), 

23 (3), or (4) of such section apply; or 

24 ‘‘(2) the Secretary of Veterans Affairs deter25 mines that access to the drug is essential to the 


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1 health of beneficiaries under the laws administered 

2 by the Secretary.’’. 

3 (b) CLERICAL AMENDMENT.—The table of sections 

4 at the beginning of such subchapter is amended by insert5 ing after the item relating to section 8126 the following 

6 new item: 

‘‘8126A. Procurement of generic drugs manufactured domestically.’’. 

7 (c) EFFECTIVE DATE.—The amendments made by 

8 this section shall take effect on January 1, 2025. 

9 SEC. 7. PROCUREMENT BY DEPARTMENT OF DEFENSE OF 

10 GENERIC DRUGS MANUFACTURED DOMESTI11 CALLY. 

12 (a) IN GENERAL.—Chapter 55 of title 10, United 

13 States Code, is amended by inserting after section 1074g 

14 the following new section: 

15 ‘‘§ 1074g–1. Procurement of generic drugs manufac16 tured domestically 

17 ‘‘(a) IN GENERAL.—Subject to subsection (b), the 

18 Secretary of Defense may only procure a generic drug if 

19 it is a generic drug manufactured domestically, as de20 scribed in section 2(b) of the Accelerating Movement of 

21 Essential Rx Items to Create Access to National Drug Re22 sources for U.S. Government Services Act. 

23 ‘‘(b) EXCEPTIONS.—Subsection (a) shall not apply 

24 with respect to a drug during any period for which— 


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1 ‘‘(1) the Secretary of Health and Human Serv2 ices has notified the Secretary of Defense pursuant 

3 to section 2(a) of the Accelerating Movement of Es4 sential Rx Items to Create Access to National Drug 

5 Resources for U.S. Government Services Act that 

6 the circumstances under paragraph (2), (3), or (4) 

7 of such section apply; or 

8 ‘‘(2) the Secretary of Defense determines that 

9 access to the drug is essential to the health of bene10 ficiaries under the TRICARE program.’’. 

11 (b) CLERICAL AMENDMENT.—The table of sections 

12 at the beginning of such chapter is amended by inserting 

13 after the item relating to section 1074g the following new 

14 item: 

‘‘1074g–1. Procurement of generic drugs manufactured domestically.’’. 

15 (c) EFFECTIVE DATE.—The amendments made by 

16 this section shall take effect on January 1, 2025. 

Æ 


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