I 
118TH CONGRESS 
1ST SESSION H. R. 5958 
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. 
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 deter-
mined 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Drug-price Trans-
parency for Consumers Act of 2023’’ or the ‘‘DTC Act 
of 2023’’. 
SEC. 2. FINDINGS; SENSE OF CONGRESS. 
(a) FINDINGS.—Congress finds the following: 
(1) Direct-to-consumer advertising of prescrip-
tion pharmaceuticals is legally permitted in only 2 
developed countries, the United States and New 
Zealand. 
(2) In 2018, pharmaceutical ad spending ex-
ceeded $6,046,000,000, a 4.8-percent increase over 
2017, resulting in the average American seeing 9 
drug advertisements per day. 
(3) The most commonly advertised medication 
in the United States in 2020 had a list price of more 
than $6,000 for a one-month’s supply. 
(4) A 2021 Government Accountability Office 
report found that two-thirds of all direct-to-con-
sumer drug advertising between 2016 and 2018 was 
concentrated among 39 brand-name drugs or 
biologicals, about half of which were recently ap-
proved by the Food and Drug Administration. 
(5) According to a 2011 Congressional Budget 
Office report, pharmaceutical manufacturers adver-
tise their products directly to consumers in an at-
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tempt to boost demand for their products and there-
by raise the price that consumers are willing to pay, 
increase the quantity of drugs sold, or achieve some 
combination of the two. 
(6) Studies, including a 2012 systematic review 
published in the Annual Review of Public Health, a 
2005 randomized trial published in the Journal of 
the American Medical Association, and a 2004 sur-
vey published in Health Affairs, show that patients 
are more likely to ask their doctor for a specific 
medication and for the doctor to write a prescription 
for it, if a patient has seen an advertisement for 
such medication, even if such medication is not the 
most clinically appropriate for the patient or if a 
lower cost generic medication may be available. 
(7) According to a 2011 Congressional Budget 
Office report, the average number of prescriptions 
written for newly approved brand-name drugs with 
direct-to-consumer advertising was 9 times greater 
than the average number of prescriptions written for 
newly approved brand-name drugs without direct-to- 
consumer advertising. 
(8) The Centers for Medicare & Medicaid Serv-
ices is the single largest drug payer in the United 
States. Between 2016 and 2018, 58 percent of the 
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$560,000,000,000 in Medicare drug spending was 
for advertised drugs, and in 2018 alone, the 20 most 
advertised drugs on television cost Medicare and 
Medicaid a combined $34,000,000,000. 
(9) A 2021 Government Accountability Office 
report found that direct-to-consumer advertising 
may have contributed to increases in Medicare bene-
ficiary use and spending among certain drugs. 
(10) The American Medical Association has 
passed resolutions supporting the requirement for 
price transparency in any direct-to-consumer adver-
tising, stating that such advertisements on their own 
‘‘inflate demand for new and more expensive drugs, 
even when these drugs may not be appropriate’’. 
(11) A 2019 study published in the Journal of 
the American Medical Association found that health 
care consumers dramatically underestimate their 
out-of-pocket costs for certain expensive medications, 
but once they learn the wholesale acquisition cost (in 
this section referred to as the ‘‘WAC’’) of the prod-
uct, they are far better able to approximate their 
out-of-pocket costs. 
(12) Approximately half of Americans have 
high-deductible health plans, under which they often 
pay the list price of a drug until their insurance de-
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ductible is met. All of the top Medicare prescription 
drug plans use coinsurance rather than fixed-dollar 
copayments for medications on nonpreferred drug 
tiers, exposing beneficiaries to WAC prices. 
(13) Section 119 of division CC of the Consoli-
dated Appropriations Act, 2021 (Public Law 116– 
260) requires the Secretary of Health and Human 
Services to increase the use of real-time benefit tools 
to lower beneficiary costs. However, there still re-
mains a lack of available pricing tools so patients 
may not learn of their medication’s cost until after 
being given a prescription for the medication. A 
2013 study published in The Oncologist found that 
one-quarter of all cancer patients chose not to fill a 
prescription due to cost. 
(14) The Federal Government already exercises 
its authority to oversee certain aspects of direct-to- 
consumer drug advertising, including required disclo-
sures of information related to side effects, contra-
indications, and effectiveness. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that— 
(1) a lack of transparency in pricing for phar-
maceuticals has led to a lack of competition for such 
pharmaceuticals, as evidenced by a finding by the 
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Department of Health and Human Services that 
‘‘Consumers of pharmaceuticals are currently miss-
ing information that consumers of other products 
can more readily access, namely the list price of the 
product, which acts as a point of comparison when 
judging the reasonableness of prices offered for po-
tential substitute products’’ (84 Fed. Reg. 20735); 
(2) in an age where price information is ubiq-
uitous, the prices of pharmaceuticals remain shroud-
ed in secrecy and limited to those who subscribe to 
expensive drug price reporting services, which typi-
cally include pharmaceutical manufacturers or other 
health care industry entities and not the general 
public; 
(3) greater insight and transparency into drug 
prices will help consumers know if they can afford 
to complete a course of therapy before deciding to 
initiate that course of therapy; 
(4) price shopping is the mark of rational eco-
nomic behavior, and markets operate more efficiently 
when consumers have relevant information about a 
product, including its price, before making an in-
formed decision about whether to buy that product; 
(5) providing consumers with basic price infor-
mation may result in the selection of lesser cost al-
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ternatives, all else being equal relative to the pa-
tient’s care, and is integral to providing adequate 
competition in the market; 
(6) the WAC is a factual, objective, and 
uncontroversial definition for the list price of a 
medication, in that it is defined in statute, reflects 
an understood place in the supply chain, and is at 
the sole discretion of the manufacturer to set; 
(7) there is a governmental interest in ensuring 
that consumers who seek to purchase pharma-
ceuticals for purposes of promoting their health and 
safety understand the objective list price of any 
pharmaceutical that they are encouraged through 
advertisements to purchase, which allows consumers 
to make informed purchasing decisions; and 
(8) there is a governmental interest in miti-
gating wasteful expenditures and promoting the effi-
cient administration of the Medicare program by 
slowing the growth of Federal spending on prescrip-
tion drugs. 
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SEC. 3. REQUIREMENT THAT DIRECT-TO-CONSUMER AD-
VERTISEMENTS 
FOR 
DRUGS 
AND 
BIOLOGICALS INCLUDE AN APPROPRIATE 
DISCLOSURE OF PRICING INFORMATION. 
Part A of title XI of the Social Security Act is 
amended by adding at the end the following new section: 
‘‘SEC. 1150D. REQUIREMENT THAT DIRECT-TO-CONSUMER 
ADVERTISEMENTS 
FOR 
DRUGS 
AND 
BIOLOGICALS INCLUDE AN APPROPRIATE 
DISCLOSURE OF PRICING INFORMATION. 
‘‘(a) REQUIREMENT.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary shall require that each direct-to-con-
sumer advertisement for a drug or biological for 
which payment is available under title XVIII or XIX 
and which is required to include the information re-
lating to side effects, contraindications, and effec-
tiveness described in section 202.1(e)(1) of title 21, 
Code of Federal Regulations (or any successor regu-
lation) also include an appropriate disclosure of pric-
ing information, as described in subsection (b), with 
respect to such drug or biological. 
‘‘(2) EXEMPTION.—The requirement under 
paragraph (1) shall not apply to a drug or biological 
for which the wholesale acquisition cost for a 30-day 
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supply of (or, if applicable, a typical course of treat-
ment for) such drug or biological is less than $35. 
‘‘(b) APPROPRIATE DISCLOSURE OF PRICING INFOR-
MATION.—For the purposes of subsection (a), an appro-
priate disclosure of pricing information, with respect to 
a drug or biological, shall— 
‘‘(1) disclose the wholesale acquisition cost for 
a 30-day supply of (or, if applicable, a typical course 
of treatment for) such drug or biological; and 
‘‘(2) be presented clearly and conspicuously. 
‘‘(c) RULEMAKING.—Not later than 1 year after the 
date of enactment of this section, the Secretary, acting 
through the Administrator of the Centers for Medicare 
and Medicaid Services, shall promulgate final regulations 
to carry out this section, including— 
‘‘(1) the visual and audio components required 
to communicate the wholesale acquisition cost in the 
appropriate manner for the medium of the advertise-
ment; 
‘‘(2) the reasonable amount of time a manufac-
turer has to update any direct-to-consumer adver-
tisement to reflect any change to the wholesale ac-
quisition cost of the advertised drug or biological; 
and 
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‘‘(3) the way in which a manufacturer may in-
clude a brief statement explaining that certain con-
sumers may pay a different amount depending on 
their insurance coverage. 
‘‘(d) SANCTIONS.—Any manufacturer of a drug or bi-
ological, or an agent of such manufacturer, that violates 
the requirement of this section may be subject to a civil 
money penalty of not more than $100,000 for each such 
violation. The provisions of section 1128A (other than 
subsections (a) and (b)) shall apply to civil money pen-
alties under the preceding sentence in the same manner 
as they apply to a penalty or proceeding under section 
1128A(a). 
‘‘(e) PUBLIC REPORTING SYSTEM.—In order to en-
force the requirement under this section, the Secretary 
may establish a public reporting system— 
‘‘(1) to build awareness of such requirement; 
and 
‘‘(2) allow for reporting of manufacturers that 
fail to comply with such requirement. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) DRUG
AND
BIOLOGICAL.—The terms 
‘drug’ and ‘biological’ have the meaning given such 
terms in section 1861(t). 
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