Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB229 Compare Versions

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Old	New	Differences
1	1	II
2	2	119THCONGRESS
3	3	1
4	4	STSESSION S. 229
5	5	To amend title XI of the Social Security Act to require that direct-to-
6	6	consumer advertisements for prescription drugs and biological products
7	7	include an appropriate disclosure of pricing information.
8	8	IN THE SENATE OF THE UNITED STATES
9	9	JANUARY23, 2025
10	10	Mr. D
11	11	URBIN(for himself, Mr. GRASSLEY, Mr. KING, Ms. ERNST, Ms. SMITH,
12	12	Mr. W
13	13	ELCH, Mr. BLUMENTHAL, Ms. BALDWIN, and Mr. TUBERVILLE)
14	14	introduced the following bill; which was read twice and referred to the
15	15	Committee on Finance
16	16	A BILL
17	17	To amend title XI of the Social Security Act to require
18	18	that direct-to-consumer advertisements for prescription
19	19	drugs and biological products include an appropriate dis-
20	20	closure of pricing information.
21	21	Be it enacted by the Senate and House of Representa-1
22	22	tives of the United States of America in Congress assembled, 2
23	23	SECTION 1. SHORT TITLE. 3
24	24	This Act may be cited as the ‘‘Drug-price Trans-4
25	25	parency for Consumers Act of 2025’’ or the ‘‘DTC Act 5
26	26	of 2025’’. 6
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30	30	SEC. 2. FINDINGS; SENSE OF THE SENATE. 1
31	31	(a) F
32	32	INDINGS.—Congress finds the following: 2
33	33	(1) Direct-to-consumer advertising of prescrip-3
34	34	tion pharmaceuticals is legally permitted in only 2 4
35	35	developed countries, the United States and New 5
36	36	Zealand. 6
37	37	(2) In 2018, pharmaceutical ad spending ex-7
38	38	ceeded $6,046,000,000, a 4.8-percent increase over 8
39	39	2017, resulting in the average American seeing 9 9
40	40	drug advertisements per day. 10
41	41	(3) The most commonly advertised medication 11
42	42	in the United States in 2020 had a list price of more 12
43	43	than $6,000 for a one-month supply. 13
44	44	(4) A 2021 Government Accountability Office 14
45	45	report found that two-thirds of all direct-to-con-15
46	46	sumer drug advertising between 2016 and 2018 was 16
47	47	concentrated among 39 brand-name drugs or 17
48	48	biologicals, about half of which were recently ap-18
49	49	proved by the Food and Drug Administration. 19
50	50	(5) According to a 2011 Congressional Budget 20
51	51	Office report, pharmaceutical manufacturers adver-21
52	52	tise their products directly to consumers in an at-22
53	53	tempt to boost demand for their products and there-23
54	54	by raise the price that consumers are willing to pay, 24
55	55	increase the quantity of drugs sold, or achieve some 25
56	56	combination of the two. 26
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60	60	(6) Studies, including a 2012 systematic review 1
61	61	published in the Annual Review of Public Health, a 2
62	62	2005 randomized trial published in the Journal of 3
63	63	the American Medical Association, and a 2004 sur-4
64	64	vey published in Health Affairs, show that patients 5
65	65	are more likely to ask their doctor for a specific 6
66	66	medication, and the doctor is more likely to write a 7
67	67	prescription for it, if a patient has seen an advertise-8
68	68	ment for such medication, even if such medication is 9
69	69	not the most clinically appropriate for the patient or 10
70	70	if a lower cost generic medication may be available. 11
71	71	(7) According to a 2011 Congressional Budget 12
72	72	Office report, the average number of prescriptions 13
73	73	written for newly approved brand-name drugs with 14
74	74	direct-to-consumer advertising was 9 times greater 15
75	75	than the average number of prescriptions written for 16
76	76	newly approved brand-name drugs without direct-to- 17
77	77	consumer advertising. 18
78	78	(8) The Centers for Medicare & Medicaid Serv-19
79	79	ices is the single largest drug payer in the United 20
80	80	States. Between 2016 and 2018, 58 percent of the 21
81	81	$560,000,000,000 in Medicare drug spending was 22
82	82	for advertised drugs, and in 2018 alone, the 20 most 23
83	83	advertised drugs on television cost Medicare and 24
84	84	Medicaid a combined $34,000,000,000. 25
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88	88	(9) A 2021 Government Accountability Office 1
89	89	report found that direct-to-consumer advertising 2
90	90	may have contributed to increases in Medicare bene-3
91	91	ficiary use and spending among certain drugs. 4
92	92	(10) The American Medical Association has 5
93	93	passed resolutions supporting the requirement for 6
94	94	price transparency in any direct-to-consumer adver-7
95	95	tising, stating that such advertisements on their own 8
96	96	‘‘inflate demand for new and more expensive drugs, 9
97	97	even when these drugs may not be appropriate’’. 10
98	98	(11) A 2019 study published in the Journal of 11
99	99	the American Medical Association found that health 12
100	100	care consumers dramatically underestimate their 13
101	101	out-of-pocket costs for certain expensive medications, 14
102	102	but once they learn the wholesale acquisition cost (in 15
103	103	this section referred to as the ‘‘WAC’’) of the prod-16
104	104	uct, they are far better able to approximate their 17
105	105	out-of-pocket costs. 18
106	106	(12) Approximately half of Americans have 19
107	107	high-deductible health plans, under which they often 20
108	108	pay the list price of a drug until their insurance de-21
109	109	ductible is met. All of the top Medicare prescription 22
110	110	drug plans use coinsurance rather than fixed-dollar 23
111	111	copayments for medications on nonpreferred drug 24
112	112	tiers, exposing beneficiaries to WAC prices. 25
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116	116	(13) Section 119 of division CC of the Consoli-1
117	117	dated Appropriations Act, 2021 (Public Law 116– 2
118	118	260) requires the Secretary of Health and Human 3
119	119	Services to increase the use of real-time benefit tools 4
120	120	to lower beneficiary costs. However, there still re-5
121	121	mains a lack of available pricing tools, so patients 6
122	122	may not learn of their medication’s cost until after 7
123	123	being given a prescription for the medication. A 8
124	124	2013 study published in The Oncologist found that 9
125	125	one-quarter of all cancer patients chose not to fill a 10
126	126	prescription due to cost. 11
127	127	(14) The Federal Government already exercises 12
128	128	its authority to oversee certain aspects of direct-to- 13
129	129	consumer drug advertising, including required disclo-14
130	130	sures of information related to side effects, contra-15
131	131	indications, and effectiveness. 16
132	132	(b) S
133	133	ENSE OFCONGRESS.—It is the sense of Con-17
134	134	gress that— 18
135	135	(1) a lack of transparency in pricing for phar-19
136	136	maceuticals has led to a lack of competition for such 20
137	137	pharmaceuticals, as evidenced by a finding by the 21
138	138	Department of Health and Human Services that 22
139	139	‘‘Consumers of pharmaceuticals are currently miss-23
140	140	ing information that consumers of other products 24
141	141	can more readily access, namely the list price of the 25
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145	145	product, which acts as a point of comparison when 1
146	146	judging the reasonableness of prices offered for po-2
147	147	tential substitute products’’ (84 Fed. Reg. 20735); 3
148	148	(2) in an age where price information is ubiq-4
149	149	uitous, the prices of pharmaceuticals remain shroud-5
150	150	ed in secrecy and limited to those who subscribe to 6
151	151	expensive drug price reporting services, which typi-7
152	152	cally include pharmaceutical manufacturers or other 8
153	153	health care industry entities and not the general 9
154	154	public; 10
155	155	(3) greater insight and transparency into drug 11
156	156	prices will help consumers know if they can afford 12
157	157	to complete a course of therapy before deciding to 13
158	158	initiate that course of therapy; 14
159	159	(4) price shopping is the mark of rational eco-15
160	160	nomic behavior, and markets operate more efficiently 16
161	161	when consumers have relevant information about a 17
162	162	product, including its price, before making an in-18
163	163	formed decision about whether to buy that product; 19
164	164	(5) providing consumers with basic price infor-20
165	165	mation may result in the selection of lesser cost al-21
166	166	ternatives, all else being equal relative to the pa-22
167	167	tient’s care, and is integral to providing adequate 23
168	168	competition in the market; 24
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172	172	(6) the WAC is a factual, objective, and 1
173	173	uncontroversial definition for the list price of a 2
174	174	medication, in that it is defined in statute, reflects 3
175	175	an understood place in the supply chain, and is at 4
176	176	the sole discretion of the manufacturer to set; 5
177	177	(7) there is a governmental interest in ensuring 6
178	178	that consumers who seek to purchase pharma-7
179	179	ceuticals for purposes of promoting their health and 8
180	180	safety understand the objective list price of any 9
181	181	pharmaceutical that they are encouraged through 10
182	182	advertisements to purchase, which allows consumers 11
183	183	to make informed purchasing decisions; and 12
184	184	(8) there is a governmental interest in miti-13
185	185	gating wasteful expenditures and promoting the effi-14
186	186	cient administration of the Medicare program by 15
187	187	slowing the growth of Federal spending on prescrip-16
188	188	tion drugs. 17
189	189	SEC. 3. REQUIREMENT THAT DIRECT-TO-CONSUMER AD-18
190	190	VERTISEMENTS FOR PRESCRIPTION DRUGS 19
191	191	AND BIOLOGICAL PRODUCTS INCLUDE AN 20
192	192	APPROPRIATE DISCLOSURE OF PRICING IN-21
193	193	FORMATION. 22
194	194	Part A of title XI of the Social Security Act is 23
195	195	amended by adding at the end the following new section: 24
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199	199	‘‘SEC. 1150D. REQUIREMENT THAT DIRECT-TO-CONSUMER 1
200	200	ADVERTISEMENTS FOR PRESCRIPTION 2
201	201	DRUGS AND BIOLOGICALS INCLUDE AN AP-3
202	202	PROPRIATE DISCLOSURE OF PRICING INFOR-4
203	203	MATION. 5
204	204	‘‘(a) R
205	205	EQUIREMENT.— 6
206	206	‘‘(1) I
207	207	N GENERAL.—Subject to paragraph (2), 7
208	208	not later than July 1, 2026, the Secretary shall re-8
209	209	quire that each direct-to-consumer advertisement for 9
210	210	a prescription drug or biological product for which 10
211	211	payment is available under title XVIII or XIX and 11
212	212	that is required to include the information relating 12
213	213	to side effects, contraindications, and effectiveness 13
214	214	described in section 202.1(e)(1) of title 21, Code of 14
215	215	Federal Regulations (or any successor regulation) 15
216	216	also include an appropriate disclosure of pricing in-16
217	217	formation, as described in subsection (b), with re-17
218	218	spect to such prescription drug or biological product. 18
219	219	‘‘(2) E
220	220	XEMPTION.—The requirement under 19
221	221	paragraph (1) shall not apply to a prescription drug 20
222	222	or biological product for which the wholesale acquisi-21
223	223	tion cost for a 30-day supply of (or, if applicable, a 22
224	224	typical course of treatment as set forth in the ap-23
225	225	proved label for the primary indication addressed in 24
226	226	the advertisement for) such prescription drug or bio-25
227	227	logical product is less than $35. 26
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231	231	‘‘(b) APPROPRIATEDISCLOSURE OFPRICINGINFOR-1
232	232	MATION.—For the purposes of subsection (a), an appro-2
233	233	priate disclosure of pricing information, with respect to 3
234	234	a prescription drug or biological product— 4
235	235	‘‘(1) shall clearly and conspicuously disclose the 5
236	236	wholesale acquisition cost for a 30-day supply of (or, 6
237	237	if applicable, a typical course of treatment for) such 7
238	238	prescription drug or biological product; and 8
239	239	‘‘(2) may explain that a consumer may pay a 9
240	240	different amount for such prescription drug or bio-10
241	241	logical product than such wholesale acquisition cost 11
242	242	depending on the health insurance coverage of the 12
243	243	consumer. 13
244	244	‘‘(c) R
245	245	ULEMAKING.—Not later than 1 year after the 14
246	246	date of enactment of this section, the Secretary shall pro-15
247	247	mulgate final regulations to carry out this section, includ-16
248	248	ing establishing requirements for— 17
249	249	‘‘(1) the visual and audio components, with re-18
250	250	spect to each medium of direct-to-consumer adver-19
251	251	tisement, to communicate the wholesale acquisition 20
252	252	cost of the advertised prescription drug or biological 21
253	253	product; and 22
254	254	‘‘(2) the amount of time for a manufacturer to 23
255	255	update any direct-to-consumer advertisement to re-24
256	256	flect any change to the wholesale acquisition cost of 25
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260	260	the advertised prescription drug or biological prod-1
261	261	uct. 2
262	262	‘‘(d) S
263	263	ANCTIONS.—Any manufacturer of a prescrip-3
264	264	tion drug or biological product, or an agent of such manu-4
265	265	facturer, that violates the requirement of this section may 5
266	266	be subject to a civil money penalty of not more than 6
267	267	$100,000 for each such violation. The provisions of section 7
268	268	1128A (other than subsections (a) and (b)) shall apply 8
269	269	to civil money penalties under the preceding sentence in 9
270	270	the same manner as they apply to a penalty or proceeding 10
271	271	under section 1128A(a). 11
272	272	‘‘(e) P
273	273	UBLICREPORTING.—In order to enforce the 12
274	274	requirement under this section, the Secretary may use in-13
275	275	formation reported about manufacturers that fail to com-14
276	276	ply with such requirement. 15
277	277	‘‘(f) D
278	278	EFINITIONS.—In this section: 16
279	279	‘‘(1) B
280	280	IOLOGICAL PRODUCT .—The term ‘bio-17
281	281	logical product’ means any biological product (as de-18
282	282	fined in section 351(i) of the Public Health Service 19
283	283	Act) that is licensed by the Food and Drug Adminis-20
284	284	tration pursuant to section 351 and is subject to the 21
285	285	requirements of section 503(b)(1) of the Federal 22
286	286	Food, Drug, and Cosmetic Act. 23
287	287	‘‘(2) P
288	288	RESCRIPTION DRUG .—The term ‘pre-24
289	289	scription drug’ means any drug (as defined in sec-25
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293	293	tion 201(g) of the Federal Food, Drug, and Cos-1
294	294	metic Act) that has been approved by the Food and 2
295	295	Drug Administration pursuant to section 505 of 3
296	296	such Act and is subject to the requirements of sec-4
297	297	tion 503(b)(1) of such Act. 5
298	298	‘‘(3) W
299	299	HOLESALE ACQUISITION COST .—The 6
300	300	term ‘wholesale acquisition cost’ has the meaning 7
301	301	given such term in section 1847A(c)(6)(B). 8
302	302	‘‘(g) A
303	303	UTHORIZATION OF APPROPRIATIONS.—There 9
304	304	are authorized to be appropriated such sums as may be 10
305	305	necessary for the purposes of carrying out this section.’’. 11
306	306	Æ
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