II 

118TH CONGRESS 

1ST SESSION S. 935 

To require reporting regarding certain drug price increases, and for other 

purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 22, 2023 

Ms. BALDWIN (for herself, Mr. BRAUN, and Ms. SMITH) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

To require reporting regarding certain drug price increases, 

and for other purposes. 

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 ‘‘Fair Accountability 

5 and Innovative Research Drug Pricing Act of 2023’’. 

6 SEC. 2. REPORTING ON JUSTIFICATION FOR DRUG PRICE 

7 INCREASES. 

8 Title III of the Public Health Service Act (42 U.S.C. 

9 241 et seq.) is amended by adding at the end the fol10 lowing: 


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1 ‘‘PART W—DRUG PRICE REPORTING; DRUG 

2 VALUE FUND 

3 ‘‘SEC. 399OO. REPORTING ON JUSTIFICATION FOR DRUG 

4 PRICE INCREASES. 

5 ‘‘(a) DEFINITIONS.—In this section: 

6 ‘‘(1) MANUFACTURER.—The term ‘manufac7 turer’ means the person— 

8 ‘‘(A) that holds the application for a drug 

9 approved under section 505 of the Federal 

10 Food, Drug, and Cosmetic Act or the license 

11 issued under section 351 of this Act; or 

12 ‘‘(B) who is responsible for setting the 

13 price for the drug. 

14 ‘‘(2) QUALIFYING DRUG.—The term ‘qualifying 

15 drug’ means any drug that is approved under sub16 section (c) or (j) of section 505 of the Federal Food, 

17 Drug, and Cosmetic Act or licensed under subsection 

18 (a) or (k) of section 351 of this Act— 

19 ‘‘(A) that has a wholesale acquisition cost 

20 of $100 or more per month supply, or per a 

21 course of treatment that lasts less than a 

22 month, and is— 

23 ‘‘(i)(I) subject to section 503(b)(1) of 

24 the Federal Food, Drug, and Cosmetic 

25 Act; or 


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1 ‘‘(II) commonly administered by hos2 pitals (as determined by the Secretary); 

3 and 

4 ‘‘(ii) not designated by the Secretary 

5 as a vaccine; and 

6 ‘‘(B) for which, during the previous cal7 endar year, at least 1 dollar of the total amount 

8 of sales were for individuals enrolled under the 

9 Medicare program under title XVIII of the So10 cial Security Act (42 U.S.C. 1395 et seq.) or 

11 under a State Medicaid plan under title XIX of 

12 such Act (42 U.S.C. 1396 et seq.) or under a 

13 waiver of such plan. 

14 ‘‘(3) UNITED STATES MEDIAN HOUSEHOLD IN15 COME.—The term ‘United States median household 

16 income’ means median household income for the 

17 United States as published by the Census Bureau 

18 for the most recent year for which data is available. 

19 ‘‘(4) WHOLESALE ACQUISITION COST.—The 

20 term ‘wholesale acquisition cost’ has the meaning 

21 given that term in section 1847A(c)(6)(B) of the So22 cial Security Act (42 U.S.C. 1395w–3a(c)(6)(B)). 

23 ‘‘(b) REPORT.— 


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1 ‘‘(1) REPORT REQUIRED.—The manufacturer of 

2 a qualifying drug shall submit a report to the Sec3 retary if, with respect to the qualifying drug— 

4 ‘‘(A) there is an increase in the price of 

5 the qualifying drug that results in an increase 

6 in the wholesale acquisition cost of that drug 

7 that is equal to— 

8 ‘‘(i) 10 percent or more over a 12- 

9 month period beginning on or after Janu10 ary 1, 2024; or 

11 ‘‘(ii) 25 percent or more over a 36- 

12 month period beginning on or after Janu13 ary 1, 2024; or 

14 ‘‘(B) the wholesale acquisition price of the 

15 qualifying drug for the applicable year or per 

16 normal course of treatment that lasts less than 

17 1 year, as determined by the Secretary, exceeds 

18 United States median household income begin19 ning on or after January 1, 2024. 

20 ‘‘(2) REPORT DEADLINE.—Each report de21 scribed in paragraph (1) shall be submitted to the 

22 Secretary not later than 30 days prior to the 

23 planned effective date of such price increase. 

24 ‘‘(c) CONTENTS.—A report under subsection (b) 

25 shall, at a minimum, include— 


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1 ‘‘(1) with respect to the qualifying drug— 

2 ‘‘(A) the percentage by which the manufac3 turer will raise the wholesale acquisition cost of 

4 the drug on the planned effective date of such 

5 price increase, as applicable; 

6 ‘‘(B) a justification for, and description of, 

7 each manufacturer’s price increase that will 

8 occur during the 12-month period described in 

9 subsection (b)(1)(A) or the 36-month period de10 scribed in subsection (b)(1)(B), as applicable; 

11 ‘‘(C) an explanation for, and description 

12 of, the cost associated with a qualifying drug if 

13 such drug meets the criteria under subsection 

14 (b)(1)(B), as applicable; 

15 ‘‘(D) the identity of the initial developer of 

16 the drug; 

17 ‘‘(E) a description of the history of the 

18 manufacturer’s price increases for the drug 

19 since the approval of the application for the 

20 drug under section 505 of the Federal Food, 

21 Drug, and Cosmetic Act or the issuance of the 

22 license for the drug under section 351, or since 

23 the manufacturer acquired such approved appli24 cation or license, as applicable; 

25 ‘‘(F) the current list price of the drug; 


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1 ‘‘(G) the total expenditures of the manu2 facturer on— 

3 ‘‘(i) materials and manufacturing for 

4 such drug; and 

5 ‘‘(ii) acquiring patents and licensing 

6 for such drug; 

7 ‘‘(H) the percentage of total expenditures 

8 of the manufacturer on research and develop9 ment for such drug that was derived from Fed10 eral funds; 

11 ‘‘(I) the total expenditures of the manufac12 turer on research and development for such 

13 drug that is used for— 

14 ‘‘(i) basic and preclinical research; 

15 ‘‘(ii) clinical research; 

16 ‘‘(iii) new drug development; 

17 ‘‘(iv) pursuing new or expanded indi18 cations for such drug through supple19 mental applications under section 505 of 

20 the Federal Food, Drug, and Cosmetic Act 

21 or section 351 of this Act; and 

22 ‘‘(v) carrying out postmarket require23 ments related to such drug, including those 

24 under section 505(o)(3) of the Federal 

25 Food, Drug, and Cosmetic Act; 


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1 ‘‘(J) the total revenue and the net profit 

2 generated from the qualifying drug for each cal3 endar year since the approval of the application 

4 for the drug under section 505 of the Federal 

5 Food, Drug, and Cosmetic Act or the issuance 

6 of the license for the drug under section 351, 

7 or since the manufacturer acquired such ap8 proved application or license; and 

9 ‘‘(K) the total costs associated with mar10 keting and advertising for the qualifying drug; 

11 ‘‘(2) with respect to the manufacturer— 

12 ‘‘(A) the total revenue and the net profit 

13 of the manufacturer for each of the 12-month 

14 periods described in subsection (b)(1)(A) or for 

15 the 36-month period described in subsection 

16 (b)(1)(B), as applicable; 

17 ‘‘(B) all stock-based performance metrics 

18 used by the manufacturer to determine execu19 tive compensation for each of the 12-month pe20 riods described in subsection (b)(1)(A) or the 

21 36-month periods described in subsection 

22 (b)(1)(B)(ii), as applicable; and 

23 ‘‘(C) any additional information the manu24 facturer chooses to provide related to drug pric25 ing decisions, such as total expenditures on— 


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1 ‘‘(i) drug research and development; 

2 or 

3 ‘‘(ii) clinical trials on drugs that failed 

4 to receive approval by the Food and Drug 

5 Administration; and 

6 ‘‘(3) such other related information as the Sec7 retary considers appropriate. 

8 ‘‘(d) CIVIL PENALTY.—Any manufacturer of a quali9 fying drug that fails to submit a report for the drug as 

10 required by this section shall be subject to a civil penalty 

11 of $100,000 for each day on which the violation continues. 

12 ‘‘(e) PUBLIC POSTING.— 

13 ‘‘(1) IN GENERAL.—Subject to paragraph (3), 

14 not later than 30 days after the submission of a re15 port under subsection (b), the Secretary shall post 

16 the report on the public website of the Department 

17 of Health and Human Services. 

18 ‘‘(2) FORMAT.—In developing the format of 

19 such report for public posting, the Secretary shall 

20 consult stakeholders, including beneficiary groups, 

21 and shall seek feedback on the content and format 

22 from consumer advocates and readability experts to 

23 ensure such public reports are user-friendly to the 

24 public and are written in plain language that con25 sumers can readily understand. 


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1 ‘‘(3) TRADE SECRETS AND CONFIDENTIAL IN2 FORMATION.—In carrying out this section the Sec3 retary shall enforce current law concerning the pro4 tection of confidential commercial information and 

5 trade secrets.’’. 

6 ‘‘SEC. 399OO–1. USE OF CIVIL PENALTY AMOUNTS. 

7 ‘‘The Secretary shall, without further appropriation, 

8 collect civil penalties under section 399OO and use the 

9 funds derived from such civil penalties, in addition to any 

10 other amounts available to the Secretary, to carry out ac11 tivities described in this part and to improve consumer and 

12 provider information about drug value and drug price 

13 transparency. 

14 ‘‘SEC. 399OO–2. ANNUAL REPORT TO CONGRESS. 

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

16 Secretary shall submit to Congress, and post on the public 

17 website of the Department of Health and Human Services 

18 in a way that is easy to find, use, and understand, an 

19 annual report— 

20 ‘‘(1) summarizing the information reported pur21 suant to section 399OO; and 

22 ‘‘(2) including copies of the reports and sup23 porting detailed economic analyses submitted pursu24 ant to such section. 


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1 ‘‘(b) TRADE SECRETS AND CONFIDENTIAL INFORMA2 TION.—In carrying out this section the Secretary shall en3 force current law concerning the protection of confidential 

4 commercial information and trade secrets.’’. 

Æ 


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