II 

118TH CONGRESS 

2D SESSION S. 4845 

To lower the cost of drugs for all Americans. 

IN THE SENATE OF THE UNITED STATES 

JULY 30, 2024 

Mr. BOOKER (for himself and Mr. SANDERS) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To lower the cost of drugs for all Americans. 

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 ‘‘Prescription Drug Af5 fordability and Access Act’’. 

6 SEC. 2. ESTABLISHMENT OF THE BUREAU OF PRESCRIP7 TION DRUG AFFORDABILITY AND ACCESS. 

8 (a) ESTABLISHMENT.— 

9 (1) IN GENERAL.—There is established within 

10 the Department of Health and Human Services a 

11 bureau, to be known as the Bureau of Prescription 


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1 Drug Affordability and Access (in this Act referred 

2 to as the ‘‘Bureau’’) to carry out the duties de3 scribed in this section. The purposes of the Bureau 

4 are to— 

5 (A) attain lower prescription drug costs for 

6 patients; 

7 (B) decrease unnecessary government ex8 penditures on prescription drugs; and 

9 (C) ensure access to clinically beneficial 

10 prescription drugs. 

11 (2) EXECUTIVE AGENCY.—The Bureau shall be 

12 considered an Executive agency, as defined in sec13 tion 105 of title 5, United States Code. 

14 (3) DIRECTOR.— 

15 (A) APPOINTMENT.—The Bureau shall be 

16 headed by a Director (in this Act referred to as 

17 the ‘‘Director’’) who shall be appointed by the 

18 President, by and with the advice and consent 

19 of the Senate. 

20 (B) QUALIFICATION.—The President shall 

21 nominate the Director from among individuals 

22 who are citizens of the United States. 

23 (C) TERM.—The Director shall serve for a 

24 term of 5 years. The term of the first Director 

25 to be appointed shall begin on the date that is 


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1 180 days after the date of enactment of this 

2 Act. 

3 (4) CONSULTATION.— 

4 (A) CONSULTATIONS AND PUBLIC MEET5 INGS.— 

6 (i) IN GENERAL.—In carrying out the 

7 duties under this section, the Bureau 

8 shall— 

9 (I) regularly consult with rel10 evant stakeholders, including patients, 

11 representatives of relevant Federal 

12 agencies, and medical and health care 

13 finance experts; and 

14 (II) hold regular public meetings, 

15 not less frequently than quarterly, to 

16 solicit input from relevant stake17 holders. 

18 (ii) PUBLIC DISCLOSURES.—The Bu19 reau shall make publicly available a list of 

20 individuals it consults or meets with pursu21 ant to clause (i), and the organizations 

22 with which such individuals are affiliated. 

23 (B) PATIENT ENGAGEMENT.— 

24 (i) IN GENERAL.—The Director shall 

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1 resenting patients have opportunities to 

2 meaningfully engage with the Bureau as it 

3 conducts its work, including while the Bu4 reau makes appropriate price determina5 tions under section 3(d). Such opportuni6 ties may include holding regular panels, fo7 rums, and other meetings for patient en8 gagement. 

9 (ii) PETITION.—The Director shall es10 tablish a process by which patients can pe11 tition the entity and raise concerns about 

12 the price of their prescription drugs. 

13 (C) CONSUMER ADVISORY COUNCIL.— 

14 (i) ESTABLISHMENT.—The Director 

15 shall establish a Consumer Advisory Coun16 cil to advise and consult with the Bureau 

17 as it conducts its work. 

18 (ii) MEMBERSHIP.—The Council es19 tablished under this subparagraph shall be 

20 composed of not fewer than 6 members ap21 pointed by the Director. In appointing 

22 members to the Council, the Director shall 

23 ensure that at least half of the members of 

24 the Council are patients or organizations 

25 representing patients, particularly those 


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1 who have been significantly impacted by 

2 high priced medications. The Director shall 

3 also seek to appoint members to the Coun4 cil who are experts in relevant areas, in5 cluding medicine and health care finance. 

6 (iii) MEETINGS.—The Consumer Ad7 visory Council shall meet from time to time 

8 at the call of the Director but shall meet 

9 at least twice a year. 

10 (5) EMPLOYMENT CONDITION.— 

11 (A) IN GENERAL.—An individual who has 

12 a conflict of interest shall not be appointed to 

13 be a member of, or employed by, the Bureau, 

14 including the Consumer Advisory Council estab15 lished under paragraph (4)(C). 

16 (B) DISCLOSURE.—Individuals under con17 sideration for employment by, or appointment 

18 to, the Bureau, including the Consumer Advi19 sory Council, shall— 

20 (i) disclose any potential conflict of in21 terest, including the type, nature, and 

22 magnitude of the interests involved; and 

23 (ii) consent to an investigation into 

24 potential conflicts of interest, which may 


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1 be initiated at the discretion of the Sec2 retary. 

3 (b) DUTIES.—The Bureau shall carry out the fol4 lowing duties: 

5 (1) Carry out the provisions of section 3. 

6 (2) Submit the annual reports under subsection 

7 (c). 

8 (3) Any other duty that the Director determines 

9 appropriate. 

10 (c) ANNUAL REPORTING.— 

11 (1) IN GENERAL.—Not later than January 1 of 

12 the first year that is not less than 2 years after the 

13 date of enactment of this Act, and annually there14 after, the Director shall submit to Congress a report 

15 on the activities of the Bureau. 

16 (2) CONTENTS.—Each report under paragraph 

17 (1) shall contain the following: 

18 (A) A description of the activities of the 

19 Bureau, including— 

20 (i) the total estimated savings 

21 achieved by the Bureau since the most re22 cent report; 

23 (ii) the disaggregated estimated sav24 ings achieved since the most recent report, 


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1 including by each therapeutic class of pre2 scription drugs; 

3 (iii) a summary of the information 

4 submitted by prescription drug manufac5 turers as required under section 3; and 

6 (iv) the impact of the Bureau’s work 

7 on patient affordability and access to es8 sential prescription drugs. 

9 (B) Recommendations for such legislation 

10 and administrative action as the Bureau deter11 mines appropriate. 

12 (C) A copy of each report submitted by 

13 drug manufacturers as required under section 

14 3. 

15 (D) Other items, as the Bureau determines 

16 appropriate. 

17 (d) FUNDING.—There are appropriated, from 

18 amounts in the Treasury not otherwise appropriated, 

19 $50,000,000 for fiscal year 2025 and each subsequent fis20 cal year to carry out the activities of the Bureau. Amounts 

21 appropriated under the preceding sentence shall remain 

22 available until expended. 

23 SEC. 3. PRESCRIPTION DRUG CONSUMER PRICE PROTEC24 TIONS. 

25 (a) REVIEW OF PRICES.— 


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1 (1) IN GENERAL.— 

2 (A) AUTHORITY.—The Bureau shall con3 duct annual reviews of the prices of prescription 

4 drugs to ensure that the wholesale acquisition 

5 cost of, and the net cost after application of any 

6 rebates for, each such drug is appropriate. 

7 (B) MANDATORY REVIEWS.—Pursuant to 

8 subparagraph (A), the Bureau shall conduct re9 views of the prices of any prescription drug— 

10 (i)(I) for which a price increase de11 scribed in subsection (b)(2) has been im12 posed in the previous year; and 

13 (II) which surpass the revenue bench14 mark under subsection (c); or 

15 (ii) for which there is an increase in 

16 demand for the drug that is significant, as 

17 determined by the Secretary. 

18 (C) DISCRETIONARY REVIEWS.—The Bu19 reau may conduct reviews of the prices of pre20 scription drugs other than the drugs described 

21 in subparagraph (B). In conducting reviews 

22 under this subparagraph, the Bureau shall 

23 prioritize any such prescription drug— 

24 (i) that is in the top fiftieth percentile 

25 of net spending on prescription drugs 


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1 under any Federal program, including the 

2 Medicare program under title XVIII of the 

3 Social Security Act (42 U.S.C. 1395 et 

4 seq.) or the Medicaid program under title 

5 XIX of such Act (42 U.S.C. 1396 et seq.); 

6 (ii) that is in the top fiftieth per7 centile of utilization under any Federal 

8 program, including such Medicare program 

9 or such Medicaid program; 

10 (iii) that has experienced an increase 

11 in the wholesale acquisition cost or net 

12 price of 25 percent or more over the pre13 ceding 3 years; 

14 (iv) for which such review is expected 

15 to support a great patient need, such as on 

16 the basis of the therapeutic impacts and 

17 high costs of the drug; or 

18 (v) that has been identified in a pa19 tient petition pursuant to section 

20 2(a)(4)(B)(ii). 

21 (2) INFORMATION ON PRESCRIPTION DRUGS AP22 PROVED AS OF ENACTMENT.—With respect to any 

23 prescription drug that, as of the date of enactment 

24 of this Act, has in effect an application approved 

25 under section 505 of the Federal Food, Drug, and 


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1 Cosmetic Act (21 U.S.C. 355) or section 351 of the 

2 Public Health Service Act (42 U.S.C. 262), each 

3 manufacturer, not later than 180 days after such 

4 date of enactment, shall provide to the Bureau the 

5 following information: 

6 (A) The name of the prescription drug. 

7 (B) A description of the prescription drug 

8 and its approved indications. 

9 (C) The number of individuals in the 

10 United States and globally for which such pre11 scription drug is clinically indicated, 

12 disaggregated by indication, if applicable. 

13 (D) A list of patents and patent applica14 tions that claim the prescription drug; a use of 

15 the prescription drug; any formulation, metabo16 lite, or component of the prescription drug; a 

17 method of use of the prescription drug; or a 

18 method of manufacture of the prescription 

19 drug. 

20 (E) Data on any patents and government21 granted exclusivities that affect the date on 

22 which drug applications sponsored by other 

23 manufacturers may be submitted and approved 

24 by the Food and Drug Administration. 


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1 (F) The date on which the prescription 

2 drug was approved under section 505 of the 

3 Federal Food, Drug, and Cosmetic Act or sec4 tion 351 of the Public Health Service Act. 

5 (G) International price data with respect 

6 to the drug. 

7 (H) The total expenditures of the manu8 facturer and other persons on— 

9 (i) domestic and foreign research and 

10 development of the drug, including an 

11 itemized description of— 

12 (I) clinical research, including the 

13 cost of each clinical trial associated 

14 with the prescription drug, reported 

15 separately for each clinical trial; 

16 (II) the development of alter17 native dosage forms and strengths for 

18 the prescription drug molecule or 

19 combinations, including the molecule; 

20 (III) other prescription drug de21 velopment activities, such as nonclin22 ical laboratory studies and record and 

23 report maintenance; 

24 (IV) pursuing new or expanded 

25 indications for such prescription drug 


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1 through supplemental applications 

2 under section 505 of the Federal 

3 Food, Drug, and Cosmetic Act or sec4 tion 351 of the Public Health Service 

5 Act; 

6 (V) carrying out postmarket re7 quirements related to such prescrip8 tion drug, including under subsection 

9 (o) of such section 505 or such section 

10 351; 

11 (VI) carrying out risk evaluation 

12 and mitigation strategies in accord13 ance with section 505–1 of the Fed14 eral Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 355–1) or such section 

16 351; and 

17 (VII) marketing research; 

18 (ii) the acquisition of prescription 

19 drug components and packaging, in total 

20 and per unit sold, broken out by source 

21 and cost and identifying specific costs that 

22 reflect internal transfers within the manu23 facturer’s company; 

24 (iii) other acquisitions relating to the 

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1 chase of patents and licensing or acquisi2 tion of any corporate entity owning any 

3 rights to the drug during or after develop4 ment of the prescription drug; 

5 (iv) current unit costs of production 

6 and distribution of the prescription drug; 

7 (v) marketing, advertising, and edu8 cating for the promotion of a prescription 

9 drug, including a breakdown of amounts 

10 aimed at consumers, prescribers, managed 

11 care organizations, and others, irrespective 

12 of whether a prescription drug is men13 tioned in marketing, advertising, or edu14 cating; 

15 (vi) any patient assistance and co-pay 

16 programs to which the manufacturer spon17 sors or contributes; 

18 (vii) the gross revenue, net revenue, 

19 gross profit, and net profit of the manufac20 turer with respect to such prescription 

21 drug; 

22 (viii) the total number of units of such 

23 prescription drug that were sold in the 

24 United States; and 


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1 (ix) pricing information with respect 

2 to the sale of such prescription drug, in3 cluding— 

4 (I) the current wholesale acquisi5 tion cost; 

6 (II) the introductory wholesale 

7 acquisition cost; 

8 (III) the net average price real9 ized by pharmacy benefit managers 

10 for such prescription drug provided to 

11 individuals in the United States, after 

12 accounting for any rebates or other 

13 payments from the manufacturer to 

14 the pharmacy benefit manager and 

15 from the pharmacy benefit manager 

16 to the manufacturer; 

17 (IV) the list price of such pre18 scription drug charged to purchasers 

19 in each applicable prescription drug 

20 reference country; 

21 (V) the net price of such pre22 scription drug, after accounting for 

23 discounts, rebates, or other financial 

24 considerations, charged to purchasers 


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1 in each applicable prescription drug 

2 reference country; 

3 (VI) a description of the timing 

4 and magnitude of all price changes of 

5 the prescription drug since the intro6 ductory wholesale acquisition cost; 

7 and 

8 (VII) the average net price of 

9 such prescription drug for each year 

10 since first being sold in the United 

11 States. 

12 (I) Any Federal benefits and amounts and 

13 periods of impact for each such benefit received 

14 by the manufacturer with respect to the pre15 scription drug, including tax credits, Federal 

16 grants, patent applications that benefitted from 

17 such grants, patent extensions, government18 granted exclusivities, and waivers of fees. 

19 (J) Prior outside financial support for clin20 ical trials or basic and translational scientific 

21 inputs to the disclovery and development with 

22 respect to the drug, including the percentage of 

23 research and development expenditures de24 scribed in this section that were derived from 

25 Federal funds. 


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1 (K) Executive compensation for the chief 

2 executive officer, chief financial officer, and the 

3 three other most highly compensated executive 

4 officers, including bonuses, paid by such manu5 facturer, and stock options affiliated with the 

6 manufacturer that were offered to or accrued 

7 by such officers. 

8 (L) Other information as the Director may 

9 require. 

10 (3) INFORMATION ON PRESCRIPTION DRUGS AP11 PROVED AFTER ENACTMENT.—With respect to any 

12 prescription drug approved under section 505 of the 

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

14 355) or section 351 of the Public Health Service Act 

15 (42 U.S.C. 262) after the date of enactment of this 

16 Act, each manufacturer, not later than 45 days prior 

17 to introducing such prescription drug into interstate 

18 commerce in the United States, shall provide to the 

19 Bureau the following information: 

20 (A) The information described in the fol21 lowing provisions of paragraph (2), except for 

22 the information required under subparagraphs 

23 (G)(v) and (H) of such paragraph. 

24 (B) Pricing information with respect to the 

25 sale of such prescription drug, including— 


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1 (i) the planned introductory wholesale 

2 acquisition cost; 

3 (ii) the list price of such prescription 

4 drug charged or planned to be charged to 

5 purchasers in each applicable prescription 

6 drug reference country; and 

7 (iii) the net price of such prescription 

8 drug, after accounting for discounts, re9 bates, or other financial considerations, 

10 charged or planned to be charged to pur11 chasers in each applicable prescription 

12 drug reference country. 

13 (C) The estimated annual profit and rev14 enue that is expected to be generated by the 

15 prescription drug, both domestically and glob16 ally. 

17 (D) Other information as the Director may 

18 require. 

19 (b) REVIEW OF CERTAIN PRICE INCREASES.— 

20 (1) IN GENERAL.—The Bureau shall conduct a 

21 review of the price of a prescription drug for which 

22 a submission is required under paragraph (2). 

23 (2) NOTIFICATION OF INTENTION TO INCREASE

24 PRICE.—If a manufacturer intends to increase the 

25 wholesale acquisition cost of a prescription drug by 


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1 more than the percentage by which the Consumer 

2 Price Index for all urban consumers for that year 

3 exceeds such index for the preceding calendar year, 

4 such manufacturer, not later than 60 days before 

5 the price increase takes effect, shall submit to the 

6 Bureau the following information: 

7 (A) The information described in sub8 section (a)(2)(A). 

9 (B) The planned increase in the wholesale 

10 acquisition cost and the planned date the in11 crease will go into effect. 

12 (C) A justification of the planned increase 

13 in wholesale acquisition cost. 

14 (D) Any other information as the Sec15 retary may require. 

16 (c) REVENUE BENCHMARK REVIEW.— 

17 (1) IN GENERAL.—The Bureau shall conduct a 

18 review of a prescription drug when revenue for such 

19 prescription drug surpasses the revenue benchmark 

20 to ensure that the wholesale acquisition cost of the 

21 prescription drug remains appropriate. 

22 (2) REQUIRED SUBMISSION.—Not later than 60 

23 days before the manufacturer of a prescription drug 

24 anticipates the global revenue for such drug will sur25 pass the revenue benchmark, the manufacturer shall 


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1 submit to the Bureau the information outlined in 

2 subsection (a)(2)(A). 

3 (3) REVENUE BENCHMARK.— 

4 (A) IN GENERAL.—Subject to subpara5 graph (B), for purposes of this subsection, the 

6 revenue benchmark is $5,000,000,000 in global 

7 revenue. 

8 (B) UPDATE.—The Bureau may update 

9 the amount of the global benchmark over time. 

10 (d) GENERAL AUTHORITY TO REVIEW.— 

11 (1) IN GENERAL.—The Bureau may at any 

12 time review the wholesale acquisition cost of a pre13 scription drug to determine if such price is appro14 priate, including in response to a patient petition 

15 under section 2(a)(3)(B)(ii). 

16 (2) PROCEDURE.—The Bureau shall notify the 

17 manufacturer of a prescription drug it wishes to re18 view pursuant to this subsection, and, within 45 

19 days of receiving such a notification, the manufac20 turer shall submit to the Bureau information the 

21 Bureau determines necessary for such review. 

22 (e) APPROPRIATE PRICE DETERMINATIONS.— 

23 (1) CONSIDERATIONS.—In determining whether 

24 the wholesale acquisition cost or proposed wholesale 


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1 acquisition cost of a prescription drug is appro2 priate, the Bureau shall consider the following: 

3 (A) The size of the affected patient popu4 lation. 

5 (B) The therapeutic benefits of the pre6 scription drug to patients, including the extent 

7 to which such drug represents a therapeutic ad8 vance as compared to existing therapeutic alter9 natives, and the costs of such existing alter10 natives, and the extent to which such drug and 

11 therapeutic alternatives to such drug address 

12 unmet medical needs for a serious or life-threat13 ening medical condition for which treatment or 

14 diagnosis is not addressed adequately by avail15 able therapies. 

16 (C) The impact of the price on access to 

17 the prescription drug, including for patients 

18 who are uninsured, and the associated financial 

19 burden on patients who use such prescription 

20 drug. 

21 (D) The total annual expenditures by the 

22 Federal Government on the prescription drug 

23 and the budgetary impact of Federal health 

24 care programs providing coverage of the pre25 scription drug. 


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1 (E) The risk-adjusted value of Federal 

2 Government subsidies and investments related 

3 to the prescription drug. 

4 (F) The costs associated with the develop5 ment or manufacturing of the prescription 

6 drug. 

7 (G) The number of similarly effective pre8 scription drugs or alternative treatment regi9 mens for each approved use of such prescription 

10 drug. 

11 (H) Whether the prescription drug pro12 vided a clinically meaningful improvement in 

13 health outcomes, compared to other therapies 

14 available at the time of approval, as determined 

15 through comparative clinical effectiveness, in16 cluding the effects of such drug and therapeutic 

17 alternatives to such drug on specific popu18 lations, such as individuals with disabilities, the 

19 elderly, the terminally ill, children, and other 

20 patient populations. 

21 (I) The current wholesale acquisition cost 

22 of comparable prescription drugs in the United 

23 States, to the extent that those prices have been 

24 deemed appropriate. 


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1 (J) The cumulative and expected global 

2 revenue generated by the prescription drug. 

3 (K) The price of the drug in other coun4 tries, including in the prescription drug ref5 erence countries. 

6 (L) The public health benefit of the drug. 

7 (M) The information that the manufac8 turer submits to the Bureau as required under 

9 this section. 

10 (N) Any other information, as the Bureau 

11 requires. 

12 (2) SPECIAL RULES.— 

13 (A) INTERIM APPROPRIATE PRICE OF PRE14 SCRIPTION DRUGS.— 

15 (i) IN GENERAL.—For each prescrip16 tion drug described in clause (ii), the Bu17 reau shall— 

18 (I) establish an interim appro19 priate price, which shall be the lesser 

20 of— 

21 (aa) the median list price of 

22 the prescription drug in the pre23 scription drug reference coun24 tries; or 


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1 (bb) if applicable, the appro2 priate price determination made 

3 by the Bureau; and 

4 (II) direct the manufacturer to 

5 set the wholesale acquisition cost at a 

6 level that does not exceed the interim 

7 appropriate price. 

8 (ii) APPLICABLE DRUGS.—A prescrip9 tion drug described in this clause is a pre10 scription drug— 

11 (I) that— 

12 (aa) as of the date of the en13 actment of this Act, has in effect 

14 an application approved under 

15 section 505(c) of the Federal 

16 Food, Drug, and Cosmetic Act 

17 (21 U.S.C. 355(c)) or section 

18 351(a) of the Public Health Serv19 ice Act (42 U.S.C. 262(a)); and 

20 (bb) is not a listed drug or 

21 a reference product for more 

22 than 2 prescription drugs or bio23 logical products approved and 

24 currently marketed under section 

25 505(j) of the Federal Food, 


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1 Drug, and Cosmetic Act (21 

2 U.S.C. 355(j)) or under section 

3 351(k) of the Public Health 

4 Service Act (42 U.S.C. 262(k)); 

5 or 

6 (II) with respect to which the 

7 Secretary has authorized under sub8 section (g) the use of any patent, clin9 ical trial data, or other government10 granted exclusivity related to such 

11 drug by another sponsor, until the 

12 date that is 1 year after the date on 

13 which another application for such 

14 drug, for which the sponsor relies 

15 upon a such authorization under sub16 section (g), is approved under such 

17 section 505 or such section 351. 

18 (B) SPIKE IN PRICE.—If a manufacturer 

19 increases the wholesale acquisition cost of a 

20 prescription drug by more than the percentage 

21 by which the Consumer Price Index for all 

22 urban consumers for that year exceeds such 

23 index for the preceding calendar year, such pre24 scription drug shall be deemed to have a whole25 sale acquisition cost that is not appropriate unVerDate Sep 11 2014 18:28 Aug 29, 2024 Jkt 049200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\S4845.IS S4845

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1 less the Bureau determines, based on the infor2 mation submitted under paragraphs (2) and (3) 

3 of subsection (a) and under subsection (b)(2) 

4 and the considerations described in paragraph 

5 (1), that the wholesale acquisition cost is appro6 priate. 

7 (3) OPPORTUNITY TO COMMENT.—Prior to 

8 making a determination on whether the wholesale 

9 acquisition cost of a prescription drug is appro10 priate, the Bureau shall ensure relevant stake11 holders, including patients, have an opportunity to 

12 comment. 

13 (f) REQUIRED ACTIONS IF PRICE IS NOT APPRO14 PRIATE.— 

15 (1) NOTICE AND REQUIREMENT TO REMIT EX16 CESS.—If the Bureau determines that the wholesale 

17 acquisition cost or proposed wholesale acquisition 

18 cost of a prescription drug is not appropriate, the 

19 Bureau shall notify and direct the manufacturer to 

20 lower the wholesale acquisition cost to a level that 

21 would be deemed appropriate. The Bureau shall also 

22 require the manufacturer to remit the excess revenue 

23 earned as a result of the prescription drug having a 

24 price that is not appropriate. 


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1 (2) PATIENT REBATE.—The Director of the 

2 Bureau shall establish a process to distribute funds 

3 remitted under paragraph (1) to patients who were 

4 impacted by the prescription drug having a price 

5 that is not appropriate. 

6 (g) ENFORCEMENT.— 

7 (1) IN GENERAL.—If, within 30 days of receiv8 ing a notice that the wholesale acquisition cost of a 

9 prescription drug is not appropriate, the manufac10 turer of such prescription drug fails to lower the 

11 wholesale acquisition cost of a prescription drug or 

12 fails to remit excessive revenue earned in accordance 

13 with subsection (f), or if the manufacturer of a drug 

14 described in subsection (a)(3) sets an introductory 

15 wholesale acquisition cost of a drug that is not ap16 propriate, the Director shall notify the Secretary and 

17 the Secretary shall authorize the use of any patent, 

18 clinical trial data, or government-granted exclusivity 

19 by an entity for purposes of manufacturing such 

20 prescription drug for sale. An entity that wishes to 

21 manufacture such prescription drug for sale shall 

22 agree to— 

23 (A) set the wholesale acquisition cost of 

24 such prescription drug at or below the level that 

25 the Bureau determines is appropriate; and 


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1 (B) provide the prescription drug manufac2 turer with reasonable compensation, which shall 

3 be determined by the Bureau, based on the in4 formation submitted by the manufacturer under 

5 this section including— 

6 (i) the risk-adjusted value of any Fed7 eral Government subsidies and investments 

8 in research and development used to sup9 port the development of such drug; 

10 (ii) the risk-adjusted value of any in11 vestment made by such manufacturer in 

12 the research and development of such 

13 drug; 

14 (iii) the impact of the price, including 

15 license compensation payments, on meeting 

16 the medical need of all patients; 

17 (iv) the relationship between the price 

18 of such drug, including compensation pay19 ments and the health benefits of such 

20 drug; and 

21 (v) other relevant information deter22 mined appropriate by the Secretary, in co23 ordination with the Director. 

24 (2) PUBLIC MANUFACTURING.—Nothing in this 

25 section shall prevent the Secretary from entering 


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1 into arrangements for the public manufacturing of 

2 prescription drugs, including through government3 owned and contractor-operated manufacturing, pro4 duction, or distribution facilities. 

5 (3) POST LICENSING.— 

6 (A) IN GENERAL.—Any manufacturer of a 

7 prescription drug that fails to comply with the 

8 interim appropriate price under subsection 

9 (e)(2)(A)(i)(I) shall be subject to a civil mone10 tary penalty of not less than an amount equal 

11 to 150 percent of all revenues obtained by the 

12 manufacturer that are in excess of the expected 

13 revenues at the interim appropriate price. 

14 (B) PROCEDURE.—The provisions of sec15 tion 1128A, other than subsections (a) and (b) 

16 and the first sentence of subsection (c)(1) of 

17 such section, shall apply to civil monetary pen18 alties under this paragraph in the same manner 

19 as such provisions apply to a penalty or pro20 ceeding under section 1128A. 

21 (C) TRANSFER TO NATIONAL INSTITUTES

22 OF HEALTH.—The civil monetary penalties col23 lected under this paragraph shall be transferred 

24 to the National Institutes of Health to suppleVerDate Sep 11 2014 18:28 Aug 29, 2024 Jkt 049200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\S4845.IS S4845

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1 ment activities related to pharmaceutical re2 search and development. 

3 SEC. 4. DEFINITIONS. 

4 In this Act: 

5 (1) CONFLICT OF INTEREST.—The term ‘‘con6 flict of interest’’ means an association, including a 

7 financial or personal association, or past employ8 ment, that has the potential to bias or have the ap9 pearance of biasing an individual’s decisions. 

10 (2) EXCESS REVENUE.—The term ‘‘excess rev11 enue’’ means the difference between a prescription 

12 drug’s wholesale acquisition cost at the time of the 

13 Bureau review under this section and the maximum 

14 wholesale acquisition price for the prescription drugs 

15 that the Bureau determines to be appropriate. 

16 (3) GOVERNMENT-GRANTED EXCLUSIVITY.— 

17 The term ‘‘government-granted exclusivity’’ means 

18 prohibitions on the submission or effective approval 

19 of prescription drug applications granted under any 

20 of the following: 

21 (A) Clauses (ii) through (v) of section 

22 505(c)(3)(E) of the Federal Food, Drug, and 

23 Cosmetic Act (21 U.S.C. 355(c)(3)(E)). 


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1 (B) Section 505(j)(5)(B)(iv) of such Act 

2 (21 U.S.C. 355(j)(5)(B)(iv)) or clause (ii), (iii), 

3 or (iv) of section 505(j)(5)(F) of such Act. 

4 (C) Section 505A of such Act (21 U.S.C. 

5 355a). 

6 (D) Section 505E of such Act (21 U.S.C. 

7 355f). 

8 (E) Section 527 of such Act (21 U.S.C. 

9 360cc). 

10 (F) Section 351(k)(7) of such Act (42 

11 U.S.C. 262(k)(7)). 

12 (G) Any other provision of law that pro13 vides for exclusivity (or extension of exclusivity) 

14 with respect to a drug. 

15 (4) LISTED DRUG.—The term ‘‘listed drug’’ 

16 means a drug listed under section 505(j)(7) of the 

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

18 355(j)(7)). 

19 (5) MANUFACTURER.—The term ‘‘manufac20 turer’’, with respect to a prescription drug, means 

21 an entity that— 

22 (A) is the holder of the approved applica23 tion under section 505 of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 355) or 


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1 under section 351 of the Public Health Service 

2 Act (42 U.S.C. 262); and 

3 (B) is responsible for setting the price of 

4 the prescription drug. 

5 (6) PRESCRIPTION DRUG.—The term ‘‘prescrip6 tion drug’’ means any drug subject to section 505 of 

7 the Federal Food, Drug, and Cosmetic Act or sec8 tion 351 of the Public Health Service Act and to 

9 section 503(b)(2) of the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 353(b)(2)). 

11 (7) PRESCRIPTION DRUG REFERENCE COUN12 TRY.—The term ‘‘prescription drug reference coun13 try’’ means Japan, Germany, the United Kingdom, 

14 France, Italy, Canada, Australia, Spain, the Nether15 lands, Switzerland, and Sweden. 

16 (8) REFERENCE PRODUCT.—The term ‘‘ref17 erence product’’ has the meaning given the term in 

18 section 351(i) of the Public Health Service Act (42 

19 U.S.C. 262(i)). 

20 (9) SECRETARY.—The term ‘‘Secretary’’ means 

21 the Secretary of Health and Human Services. 

22 (10) WHOLESALE ACQUISITION COST.—The 

23 term ‘‘wholesale acquisition cost’’ has the meaning 

24 given that term in section 1847A(c)(6)(B) of the So25 cial Security Act (42 U.S.C. 1395w–3a(c)(6)(B)). 


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1 SEC. 5. REPEAL OF MEDICARE’S NONINTERFERENCE 

2 CLAUSE. 

3 Section 1860D–11 of the Social Security Act (42 

4 U.S.C. 1395w–111) is amended by striking subsection (i). 

Æ 


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