I 

118TH CONGRESS 

1ST SESSION H. R. 5958 

To amend title XI of the Social Security Act to require that direct-toconsumer advertisements for drugs and biologicals include an appropriate 

disclosure of pricing information. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 13, 2023 

Ms. SPANBERGER (for herself and Mr. NUNN of Iowa) introduced the 

following bill 

OCTOBER 25, 2023 

Referred to the Committee on Energy and Commerce, and in addition to the 

Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions 

as fall within the jurisdiction of the committee concerned 

A BILL 

To amend title XI of the Social Security Act to require 

that direct-to-consumer advertisements for drugs and 

biologicals include an appropriate disclosure of pricing 

information. 

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


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Drug-price Trans3 parency for Consumers Act of 2023’’ or the ‘‘DTC Act 

4 of 2023’’. 

5 SEC. 2. FINDINGS; SENSE OF CONGRESS. 

6 (a) FINDINGS.—Congress finds the following: 

7 (1) Direct-to-consumer advertising of prescrip8 tion pharmaceuticals is legally permitted in only 2 

9 developed countries, the United States and New 

10 Zealand. 

11 (2) In 2018, pharmaceutical ad spending ex12 ceeded $6,046,000,000, a 4.8-percent increase over 

13 2017, resulting in the average American seeing 9 

14 drug advertisements per day. 

15 (3) The most commonly advertised medication 

16 in the United States in 2020 had a list price of more 

17 than $6,000 for a one-month’s supply. 

18 (4) A 2021 Government Accountability Office 

19 report found that two-thirds of all direct-to-con20 sumer drug advertising between 2016 and 2018 was 

21 concentrated among 39 brand-name drugs or 

22 biologicals, about half of which were recently ap23 proved by the Food and Drug Administration. 

24 (5) According to a 2011 Congressional Budget 

25 Office report, pharmaceutical manufacturers adver26 tise their products directly to consumers in an atVerDate Sep 11 2014 08:22 Nov 03, 2023 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5958.IH H5958

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1 tempt to boost demand for their products and there2 by raise the price that consumers are willing to pay, 

3 increase the quantity of drugs sold, or achieve some 

4 combination of the two. 

5 (6) Studies, including a 2012 systematic review 

6 published in the Annual Review of Public Health, a 

7 2005 randomized trial published in the Journal of 

8 the American Medical Association, and a 2004 sur9 vey published in Health Affairs, show that patients 

10 are more likely to ask their doctor for a specific 

11 medication and for the doctor to write a prescription 

12 for it, if a patient has seen an advertisement for 

13 such medication, even if such medication is not the 

14 most clinically appropriate for the patient or if a 

15 lower cost generic medication may be available. 

16 (7) According to a 2011 Congressional Budget 

17 Office report, the average number of prescriptions 

18 written for newly approved brand-name drugs with 

19 direct-to-consumer advertising was 9 times greater 

20 than the average number of prescriptions written for 

21 newly approved brand-name drugs without direct-to22 consumer advertising. 

23 (8) The Centers for Medicare & Medicaid Serv24 ices is the single largest drug payer in the United 

25 States. Between 2016 and 2018, 58 percent of the 


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1 $560,000,000,000 in Medicare drug spending was 

2 for advertised drugs, and in 2018 alone, the 20 most 

3 advertised drugs on television cost Medicare and 

4 Medicaid a combined $34,000,000,000. 

5 (9) A 2021 Government Accountability Office 

6 report found that direct-to-consumer advertising 

7 may have contributed to increases in Medicare bene8 ficiary use and spending among certain drugs. 

9 (10) The American Medical Association has 

10 passed resolutions supporting the requirement for 

11 price transparency in any direct-to-consumer adver12 tising, stating that such advertisements on their own 

13 ‘‘inflate demand for new and more expensive drugs, 

14 even when these drugs may not be appropriate’’. 

15 (11) A 2019 study published in the Journal of 

16 the American Medical Association found that health 

17 care consumers dramatically underestimate their 

18 out-of-pocket costs for certain expensive medications, 

19 but once they learn the wholesale acquisition cost (in 

20 this section referred to as the ‘‘WAC’’) of the prod21 uct, they are far better able to approximate their 

22 out-of-pocket costs. 

23 (12) Approximately half of Americans have 

24 high-deductible health plans, under which they often 

25 pay the list price of a drug until their insurance deVerDate Sep 11 2014 08:22 Nov 03, 2023 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5958.IH H5958

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1 ductible is met. All of the top Medicare prescription 

2 drug plans use coinsurance rather than fixed-dollar 

3 copayments for medications on nonpreferred drug 

4 tiers, exposing beneficiaries to WAC prices. 

5 (13) Section 119 of division CC of the Consoli6 dated Appropriations Act, 2021 (Public Law 116– 

7 260) requires the Secretary of Health and Human 

8 Services to increase the use of real-time benefit tools 

9 to lower beneficiary costs. However, there still re10 mains a lack of available pricing tools so patients 

11 may not learn of their medication’s cost until after 

12 being given a prescription for the medication. A 

13 2013 study published in The Oncologist found that 

14 one-quarter of all cancer patients chose not to fill a 

15 prescription due to cost. 

16 (14) The Federal Government already exercises 

17 its authority to oversee certain aspects of direct-to18 consumer drug advertising, including required disclo19 sures of information related to side effects, contra20 indications, and effectiveness. 

21 (b) SENSE OF CONGRESS.—It is the sense of Con22 gress that— 

23 (1) a lack of transparency in pricing for phar24 maceuticals has led to a lack of competition for such 

25 pharmaceuticals, as evidenced by a finding by the 


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1 Department of Health and Human Services that 

2 ‘‘Consumers of pharmaceuticals are currently miss3 ing information that consumers of other products 

4 can more readily access, namely the list price of the 

5 product, which acts as a point of comparison when 

6 judging the reasonableness of prices offered for po7 tential substitute products’’ (84 Fed. Reg. 20735); 

8 (2) in an age where price information is ubiq9 uitous, the prices of pharmaceuticals remain shroud10 ed in secrecy and limited to those who subscribe to 

11 expensive drug price reporting services, which typi12 cally include pharmaceutical manufacturers or other 

13 health care industry entities and not the general 

14 public; 

15 (3) greater insight and transparency into drug 

16 prices will help consumers know if they can afford 

17 to complete a course of therapy before deciding to 

18 initiate that course of therapy; 

19 (4) price shopping is the mark of rational eco20 nomic behavior, and markets operate more efficiently 

21 when consumers have relevant information about a 

22 product, including its price, before making an in23 formed decision about whether to buy that product; 

24 (5) providing consumers with basic price infor25 mation may result in the selection of lesser cost alVerDate Sep 11 2014 08:22 Nov 03, 2023 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5958.IH H5958

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1 ternatives, all else being equal relative to the pa2 tient’s care, and is integral to providing adequate 

3 competition in the market; 

4 (6) the WAC is a factual, objective, and 

5 uncontroversial definition for the list price of a 

6 medication, in that it is defined in statute, reflects 

7 an understood place in the supply chain, and is at 

8 the sole discretion of the manufacturer to set; 

9 (7) there is a governmental interest in ensuring 

10 that consumers who seek to purchase pharma11 ceuticals for purposes of promoting their health and 

12 safety understand the objective list price of any 

13 pharmaceutical that they are encouraged through 

14 advertisements to purchase, which allows consumers 

15 to make informed purchasing decisions; and 

16 (8) there is a governmental interest in miti17 gating wasteful expenditures and promoting the effi18 cient administration of the Medicare program by 

19 slowing the growth of Federal spending on prescrip20 tion drugs. 


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1 SEC. 3. REQUIREMENT THAT DIRECT-TO-CONSUMER AD2 VERTISEMENTS FOR DRUGS AND 

3 BIOLOGICALS INCLUDE AN APPROPRIATE 

4 DISCLOSURE OF PRICING INFORMATION. 

5 Part A of title XI of the Social Security Act is 

6 amended by adding at the end the following new section: 

7 ‘‘SEC. 1150D. REQUIREMENT THAT DIRECT-TO-CONSUMER 

8 ADVERTISEMENTS FOR DRUGS AND 

9 BIOLOGICALS INCLUDE AN APPROPRIATE 

10 DISCLOSURE OF PRICING INFORMATION. 

11 ‘‘(a) REQUIREMENT.— 

12 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

13 the Secretary shall require that each direct-to-con14 sumer advertisement for a drug or biological for 

15 which payment is available under title XVIII or XIX 

16 and which is required to include the information re17 lating to side effects, contraindications, and effec18 tiveness described in section 202.1(e)(1) of title 21, 

19 Code of Federal Regulations (or any successor regu20 lation) also include an appropriate disclosure of pric21 ing information, as described in subsection (b), with 

22 respect to such drug or biological. 

23 ‘‘(2) EXEMPTION.—The requirement under 

24 paragraph (1) shall not apply to a drug or biological 

25 for which the wholesale acquisition cost for a 30-day 


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1 supply of (or, if applicable, a typical course of treat2 ment for) such drug or biological is less than $35. 

3 ‘‘(b) APPROPRIATE DISCLOSURE OF PRICING INFOR4 MATION.—For the purposes of subsection (a), an appro5 priate disclosure of pricing information, with respect to 

6 a drug or biological, shall— 

7 ‘‘(1) disclose the wholesale acquisition cost for 

8 a 30-day supply of (or, if applicable, a typical course 

9 of treatment for) such drug or biological; and 

10 ‘‘(2) be presented clearly and conspicuously. 

11 ‘‘(c) RULEMAKING.—Not later than 1 year after the 

12 date of enactment of this section, the Secretary, acting 

13 through the Administrator of the Centers for Medicare 

14 and Medicaid Services, shall promulgate final regulations 

15 to carry out this section, including— 

16 ‘‘(1) the visual and audio components required 

17 to communicate the wholesale acquisition cost in the 

18 appropriate manner for the medium of the advertise19 ment; 

20 ‘‘(2) the reasonable amount of time a manufac21 turer has to update any direct-to-consumer adver22 tisement to reflect any change to the wholesale ac23 quisition cost of the advertised drug or biological; 

24 and 


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1 ‘‘(3) the way in which a manufacturer may in2 clude a brief statement explaining that certain con3 sumers may pay a different amount depending on 

4 their insurance coverage. 

5 ‘‘(d) SANCTIONS.—Any manufacturer of a drug or bi6 ological, or an agent of such manufacturer, that violates 

7 the requirement of this section may be subject to a civil 

8 money penalty of not more than $100,000 for each such 

9 violation. The provisions of section 1128A (other than 

10 subsections (a) and (b)) shall apply to civil money pen11 alties under the preceding sentence in the same manner 

12 as they apply to a penalty or proceeding under section 

13 1128A(a). 

14 ‘‘(e) PUBLIC REPORTING SYSTEM.—In order to en15 force the requirement under this section, the Secretary 

16 may establish a public reporting system— 

17 ‘‘(1) to build awareness of such requirement; 

18 and 

19 ‘‘(2) allow for reporting of manufacturers that 

20 fail to comply with such requirement. 

21 ‘‘(f) DEFINITIONS.—In this section: 

22 ‘‘(1) DRUG AND BIOLOGICAL.—The terms 

23 ‘drug’ and ‘biological’ have the meaning given such 

24 terms in section 1861(t). 


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1 ‘‘(2) WHOLESALE ACQUISITION COST.—The 

2 term ‘wholesale acquisition cost’ has the meaning 

3 given such term in section 1847A(c)(6)(B). 

4 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

5 are authorized to be appropriated such sums as may be 

6 necessary for the purposes of carrying out this section.’’. 

Æ 


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