Prescription Drug Affordability and Access Act

II 116TH CONGRESS 2D SESSION S. 3166 To lower the cost of drugs for all Americans. IN THE SENATE OF THE UNITED STATES JANUARY 8, 2020 Mr. BOOKER (for himself, Mr. SANDERS, and Ms. HARRIS) introduced the fol- lowing 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Prescription Drug Af- 4 fordability and Access Act’’. 5 SEC. 2. ESTABLISHMENT OF THE BUREAU OF PRESCRIP- 6 TION DRUG AFFORDABILITY AND ACCESS. 7 (a) ESTABLISHMENT.— 8 (1) IN GENERAL.—There is established within 9 the Department of Health and Human Services an 10 independent bureau, known as the Bureau of Pre- 11 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 2 •S 3166 IS scription Drug Affordability and Access (in this Act 1 referred to as the ‘‘Bureau’’) to carry out the duties 2 described in this section. The purposes of the Bu- 3 reau are to— 4 (A) attain lower prescription drug costs for 5 patients; 6 (B) decrease government expenditures on 7 prescription drugs; and 8 (C) ensure access to prescription drugs. 9 (2) EXECUTIVE AGENCY.—The Bureau shall be 10 considered an Executive agency, as defined in sec- 11 tion 105 of title 5, United States Code. 12 (3) DIRECTOR.— 13 (A) APPOINTMENT.—The Bureau shall be 14 headed by a Director (in this Act referred to as 15 the ‘‘Director’’) who shall be appointed by the 16 President, by and with the advice and consent 17 of the Senate. 18 (B) QUALIFICATION.—The President shall 19 nominate the Director from among individuals 20 who are citizens of the United States. 21 (C) TERM.—The Director shall serve for a 22 term of 5 years. The term of the first Director 23 to be appointed shall begin on the date that is 24 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 3 •S 3166 IS 180 days after the date of enactment of this 1 Act. 2 (4) CONSULTATION.— 3 (A) IN GENERAL.—In carrying out the du- 4 ties under this section, the Bureau shall regu- 5 larly consult with relevant stakeholders, includ- 6 ing patients, representatives of relevant Federal 7 agencies, and medical and health care finance 8 experts. The Bureau shall have regular public 9 meetings to solicit input from relevant stake- 10 holders. 11 (B) PATIENT ENGAGEMENT.— 12 (i) IN GENERAL.—The Director shall 13 ensure that patients or organizations rep- 14 resenting patients have opportunities to 15 meaningfully engage with the Bureau as it 16 conducts its work, including while the Bu- 17 reau makes appropriate price determina- 18 tions under section 3(d). Such opportuni- 19 ties may include holding regular panels, fo- 20 rums, and other meetings for patient en- 21 gagement. 22 (ii) PETITION.—The Director shall es- 23 tablish a process by which patients can pe- 24 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 4 •S 3166 IS tition the entity and raise concerns about 1 the price of their prescription drugs. 2 (C) CONSUMER ADVISORY COUNCIL.— 3 (i) ESTABLISHMENT.—The Director 4 shall establish a Consumer Advisory Coun- 5 cil to advise and consult with the Bureau 6 as it conducts its work. 7 (ii) MEMBERSHIP.—The Council es- 8 tablished under this subparagraph shall be 9 composed of not fewer than 6 members ap- 10 pointed by the Director. In appointing 11 members to the Council, the Director shall 12 ensure that at least half of the members of 13 the Council are patients or organizations 14 representing patients, particularly those 15 who have been significantly impacted by 16 high priced medications. The Director shall 17 also seek to appoint members to the Coun- 18 cil who are experts in relevant areas, in- 19 cluding medicine and health care finance. 20 (iii) MEETINGS.—The Consumer Ad- 21 visory Council shall meet from time to time 22 at the call of the Director but shall meet 23 at least twice a year. 24 (5) EMPLOYMENT CONDITION.— 25 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 5 •S 3166 IS (A) IN GENERAL.—An individual who has 1 a conflict of interest shall not be appointed to 2 be a member of, or employed by, the Bureau, 3 including the Consumer Advisory Council estab- 4 lished under paragraph (4)(C). 5 (B) DISCLOSURE.—Individuals under con- 6 sideration for employment by, or appointment 7 to, the Bureau, including the Consumer Advi- 8 sory Council, must disclose any potential con- 9 flict of interest, including the type, nature, and 10 magnitude of the interests involved. 11 (b) DUTIES.—The Bureau shall carry out the fol- 12 lowing duties: 13 (1) Carry out the provisions of section 3. 14 (2) Submit the annual reports under subsection 15 (c). 16 (3) Any other duty that the Director determines 17 appropriate. 18 (c) ANNUAL REPORTING.— 19 (1) IN GENERAL.—Not later than January 1, 20 2021, and annually thereafter, the Director shall 21 submit to Congress a report on the activities of the 22 Bureau. 23 (2) CONTENTS.—Each report under paragraph 24 (1) shall contain the following: 25 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 6 •S 3166 IS (A) A description of the activities of the 1 Bureau, including— 2 (i) the total estimated savings 3 achieved by the Bureau since the most re- 4 cent report; 5 (ii) the disaggregated savings achieved 6 since the most recent report, including by 7 each therapeutic class of prescription 8 drugs; 9 (iii) a summary of the information 10 submitted by prescription drug manufac- 11 turers as required under section 3; and 12 (iv) the impact of the Bureau’s work 13 on patient affordability and access to pre- 14 scription drugs. 15 (B) Recommendations for such legislation 16 and administrative action as the Bureau deter- 17 mines appropriate. 18 (C) A copy of each report submitted by 19 drug manufacturers as required under section 20 3. 21 (D) Other items that the Bureau deter- 22 mines appropriate. 23 (d) FUNDING.—There are appropriated, from 24 amounts in the Treasury not otherwise appropriated, 25 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 7 •S 3166 IS $50,000,000 for fiscal year 2020 and each subsequent fis- 1 cal year to carry out the activities of the Bureau. Amounts 2 appropriated under the preceding sentence shall remain 3 available until expended. 4 SEC. 3. PRESCRIPTION DRUG CONSUMER PRICE PROTEC- 5 TIONS. 6 (a) REVIEW OF PRICES.— 7 (1) IN GENERAL.—The Bureau shall conduct 8 reviews of the prices of prescription drugs to ensure 9 that the wholesale acquisition cost of each such drug 10 is appropriate. 11 (2) INFORMATION ON PRESCRIPTION DRUGS AP- 12 PROVED AS OF ENACTMENT.— 13 (A) MANUFACTURER SUBMISSION.—With 14 respect to any prescription drug that, as of the 15 date of enactment of this Act, has in effect an 16 application approved under section 505 of the 17 Federal Food, Drug, and Cosmetic Act (21 18 U.S.C. 355) or section 351 of the Public Health 19 Service Act (42 U.S.C. 262), each manufac- 20 turer, not later than 180 days after such date 21 of enactment, shall provide to the Bureau the 22 following information: 23 (i) The name of the prescription drug. 24 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 8 •S 3166 IS (ii) A description of the prescription 1 drug and its approved indications. 2 (iii) The number of individuals in the 3 United States and globally for which such 4 prescription drug is clinically indicated. 5 (iv) A list of patents that claim the 6 prescription drug, a use of the prescription 7 drug, a form of the prescription drug, a 8 method of use of the prescription drug, or 9 a method of manufacture of the prescrip- 10 tion drug. 11 (v) A list of government-granted 12 exclusivities that prohibit the submission 13 or approval of a prescription drug and the 14 date that each such government-granted 15 exclusivity was granted. 16 (vi) The date on which the prescrip- 17 tion drug was approved under such section 18 505 or such section 351 of the Public 19 Health Service Act. 20 (vii) The total expenditures of the 21 manufacturer on— 22 (I) domestic and foreign research 23 and development, including an 24 itemized description of— 25 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 9 •S 3166 IS (aa) clinical research, includ- 1 ing the cost of each clinical trial 2 associated with the prescription 3 drug, reported separately for 4 each clinical trial; 5 (bb) the development of al- 6 ternative dosage forms and 7 strengths for the prescription 8 drug molecule or combinations, 9 including the molecule; 10 (cc) other prescription drug 11 development activities, such as 12 nonclinical laboratory studies and 13 record and report maintenance; 14 (dd) pursuing new or ex- 15 panded indications for such pre- 16 scription drug through supple- 17 mental applications under such 18 section 505 or such section 351; 19 (ee) carrying out postmarket 20 requirements related to such pre- 21 scription drug, including under 22 subsection (o) of such section 23 505 or such section 351; 24 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 10 •S 3166 IS (ff) carrying out risk evalua- 1 tion and mitigation strategies in 2 accordance with section 505–1 of 3 the Federal Food, Drug, and 4 Cosmetic Act (21 U.S.C. 355–1) 5 or such section 351; and 6 (gg) marketing research; 7 (II) the acquisition of prescrip- 8 tion drug components and packaging, 9 in total and per unit sold, broken out 10 by source and cost and identifying 11 specific costs that reflect internal 12 transfers within the manufacturer’s 13 company; 14 (III) other acquisitions relating 15 to the prescription drug, including for 16 the purchase of patents and licensing 17 or acquisition of any corporate entity 18 owning any rights to the drug during 19 or after development of the prescrip- 20 tion drug; 21 (IV) the cost of manufacturing 22 the prescription drug; 23 (V) marketing, advertising, and 24 educating for the promotion of a pre- 25 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 11 •S 3166 IS scription drug, including a breakdown 1 of amounts aimed at consumers, pre- 2 scribers, managed care organizations, 3 and others, irrespective of whether a 4 prescription drug is mentioned in 5 marketing, advertising, or educating; 6 and 7 (VI) patient assistance and co- 8 pay programs that the manufacturer 9 sponsors or contributes to. 10 (viii) The gross revenue, net revenue, 11 gross profit, and net profit of the manufac- 12 turer with respect to such prescription 13 drug. 14 (ix) The total number of units of such 15 prescription drug that were sold in inter- 16 state commerce. 17 (x) Pricing information with respect 18 to the sale of such prescription drug, in- 19 cluding— 20 (I) the current wholesale acquisi- 21 tion cost; 22 (II) the introductory wholesale 23 acquisition cost; 24 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 12 •S 3166 IS (III) the net average price real- 1 ized by pharmacy benefit managers 2 for such prescription drug provided to 3 individuals in the United States, after 4 accounting for any rebates or other 5 payments from the manufacturer to 6 the pharmacy benefit manager and 7 from the pharmacy benefit manager 8 to the manufacturer; 9 (IV) the list price of such pre- 10 scription drug charged to purchasers 11 in each applicable prescription drug 12 reference country; 13 (V) the net price of such pre- 14 scription drug, after accounting for 15 discounts, rebates, or other financial 16 considerations, charged to purchasers 17 in each applicable prescription drug 18 reference country; 19 (VI) a description of all price 20 changes of the prescription drug since 21 the introductory wholesale acquisition 22 cost; and 23 (VII) the average net price of 24 such prescription drug for each year 25 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 13 •S 3166 IS since first being sold in the United 1 States. 2 (xi) Any Federal benefits and 3 amounts and periods of impact for each 4 such benefit received by the manufacturer 5 with respect to the prescription drug, in- 6 cluding tax credits, Federal grants, patent 7 applications that benefitted from such 8 grants, patent extensions, exclusivity peri- 9 ods, and waivers of fees. 10 (xii) The percentage of research and 11 development expenditures described in this 12 section that were derived from Federal 13 funds. 14 (xiii) Executive compensation for the 15 chief executive officer, chief financial offi- 16 cer, and the three other most highly com- 17 pensated executive officers, including bo- 18 nuses, paid by such manufacturer, and 19 stock options affiliated with the manufac- 20 turer that were offered to or accrued by 21 such officers. 22 (xiv) Other information as the Direc- 23 tor may require. 24 VerDate Sep 11 2014 04:31 Jan 09, 2020 Jkt 099200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S3166.IS S3166 kjohnson on DSK79L0C42PROD with BILLS 14 •S 3166 IS (B) BUREAU REVIEW PRIORITIES.—In re- 1 viewing submissions under subparagraph (A), 2 the Bureau shall prioritize prescription drugs 3 that meet any of the following criteria: 4 (i) In the top 50th percentile of net 5 spending on prescription drugs under any 6 Federal program, including the Medicare 7 program under title XVIII of the Social 8 Security Act (42 U.S.C. 1395 et seq.) or 9 the Medicaid program under title XIX of 10 such Act (42 U.S.C. 1396 et seq.). 11 (ii) In the top 50th percentile of utili- 12 zation under any Federal program, includ- 13 ing such Medicare program or such Med- 14 ic [Text truncated for display. 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