119-hr3789

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3789 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 3789

To amend title XI of the Social Security Act to require that direct-to-
consumer advertisements for prescription drugs and biological products 
 include an appropriate disclosure of pricing information.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 June 5, 2025

 Mr. Taylor (for himself and Ms. Schakowsky) introduced the following 
 bill; which was 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 prescription drugs and biological products 
 include an appropriate disclosure of pricing information.

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

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Drug-price Transparency for 
Consumers Act of 2025'' or the ``DTC Act of 2025''.

SEC. 2. FINDINGS; SENSE OF THE SENATE.

    (a) 

=== Findings ===
-Congress finds the following:

    (1) Direct-to-consumer advertising of prescription 
 pharmaceuticals is legally permitted in only 2 developed 
 countries, the United States and New Zealand.

    (2) In 2018, pharmaceutical ad spending exceeded 
 $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 supply.

    (4) A 2021 Government Accountability Office report found 
 that two-thirds of all direct-to-consumer drug advertising 
 between 2016 and 2018 was concentrated among 39 brand-name 
 drugs or biologicals, about half of which were recently 
 approved by the Food and Drug Administration.

    (5) According to a 2011 Congressional Budget Office report, 
 pharmaceutical manufacturers advertise their products directly 
 to consumers in an attempt to boost demand for their products 
 and thereby 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 survey published in Health Affairs, show that 
 patients are more likely to ask their doctor for a specific 
 medication, and the doctor is more likely 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 Services is the 
 single largest drug payer in the United States. Between 2016 
 and 2018, 58 percent of the $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 beneficiary 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 advertising, 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 product, 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 deductible 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 Consolidated 
 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 remains 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 disclosures of information 
 related to side effects, contraindications, and effectiveness.

    (b) Sense of Congress.--It is the sense of Congress that--

    (1) a lack of transparency in pricing for pharmaceuticals 
 has led to a lack of competition for such pharmaceuticals, as 
 evidenced by a finding by the Department of Health and Human 
 Services that ``Consumers of pharmaceuticals are currently 
 missing 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 potential substitute products'' (84 Fed. 
 Reg. 20735);

    (2) in an age where price information is ubiquitous, the 
 prices of pharmaceuticals remain shrouded in secrecy and 
 limited to those who subscribe to expensive drug price 
 reporting services, which typically 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 economic 
 behavior, and markets operate more efficiently when consumers 
 have relevant information about a product, including its price, 
 before making an informed decision about whether to buy that 
 product;

    (5) providing consumers with basic price information may 
 result in the selection of lesser cost alternatives, all else 
 being equal relative to the patient'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 pharmaceuticals 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 mitigating wasteful 
 expenditures and promoting the efficient administration of the 
 Medicare program by slowing the growth of Federal spending on 
 prescription drugs.

SEC. 3. REQUIREMENT THAT DIRECT-TO-CONSUMER ADVERTISEMENTS FOR 
 PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS 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 
 PRESCRIPTION DRUGS AND BIOLOGICALS INCLUDE AN APPROPRIATE 
 DISCLOSURE OF PRICING INFORMATION.

 ``

    (a) Requirement.--
 ``

    (1) In general.--Subject to paragraph

    (2) , not later than 
 July 1, 2026, the Secretary shall require that each direct-to-
 consumer advertisement for a prescription drug or biological 
 product for which payment is available under title XVIII or XIX 
 and that is required to include the information relating to 
 side effects, contraindications, and effectiveness described in 
 

section 202.1

    (e)

    (1) of title 21, Code of Federal Regulations 
 (or any successor regulation) also include an appropriate 
 disclosure of pricing information, as described in subsection

    (b) , with respect to such prescription drug or biological 
 product.
 ``

    (2) Exemption.--The requirement under paragraph

    (1) shall 
 not apply to a prescription drug or biological product for 
 which the wholesale acquisition cost for a 30-day supply of 
 (or, if applicable, a typical course of treatment as set forth 
 in the approved label for the primary indication addressed in 
 the advertisement for) such prescription drug or biological 
 product is less than $35.
 ``

    (b) Appropriate Disclosure of Pricing Information.--For the 
purposes of subsection

    (a) , an appropriate disclosure of pricing 
information, with respect to a prescription drug or biological 
product--
 ``

    (1) shall clearly and conspicuously disclose the 
 wholesale acquisition cost for a 30-day supply of (or, if 
 applicable, a typical course of treatment for) such 
 prescription drug or biological product; and
 ``

    (2) may explain that a consumer may pay a different 
 amount for such prescription drug or biological product than 
 such wholesale acquisition cost depending on the health 
 insurance coverage of the consumer.
 ``
            (c) Rulemaking.--Not later than 1 year after the date of 
enactment of this section, the Secretary shall promulgate final 
regulations to carry out this section, including establishing 
requirements for--
 ``

    (1) the visual and audio components, with respect to each 
 medium of direct-to-consumer advertisement, to communicate the 
 wholesale acquisition cost of the advertised prescription drug 
 or biological product; and
 ``

    (2) the amount of time for a manufacturer to update any 
 direct-to-consumer advertisement to reflect any change to the 
 wholesale acquisition cost of the advertised prescription drug 
 or biological product.
 ``
            (d) Sanctions.--Any manufacturer of a prescription drug or 
biological product, 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 penalties under the preceding sentence in the same manner as they 
apply to a penalty or proceeding under 

section 1128A

    (a) .
 ``

    (e) Public Reporting.--In order to enforce the requirement under 
this section, the Secretary may use information reported about 
manufacturers that fail to comply with such requirement.
 ``

    (f) 

=== Definitions. ===
-In this section:
 ``

    (1) Biological product.--The term `biological product' 
 means any biological product (as defined in 

section 351
            (i) of 
 the Public Health Service Act) that is licensed by the Food and 
 Drug Administration pursuant to 

section 351 and is subject to 
 the requirements of 

section 503

    (b)

    (1) of the Federal Food, 
 Drug, and Cosmetic Act.
 ``

    (2) Prescription drug.--The term `prescription drug' 
 means any drug (as defined in 

section 201

    (g) of the Federal 
 Food, Drug, and Cosmetic Act) that has been approved by the 
 Food and Drug Administration pursuant to 

section 505 of such 
 Act and is subject to the requirements of 

section 503

    (b)

    (1) of 
 such Act.
 ``

    (3) Wholesale acquisition cost.--The term `wholesale 
 acquisition cost' has the meaning given such term in 

section 1847A
            (c) (6)
        (B) .
 ``

    (g) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for the purposes of carrying 
out this section.''.
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