Arizona 2025 Regular Session

Arizona House Bill HB2757 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	REFERENCE TITLE: essential drugs; price increases; limits State of Arizona House of Representatives Fifty-seventh Legislature First Regular Session 2025 HB 2757 Introduced by Representatives Mathis: Cavero, Crews, De Los Santos, Gutierrez, Villegas AN ACT amending title 36, Arizona Revised Statutes, by adding chapter 42; relating to prescription drugs. (TEXT OF BILL BEGINS ON NEXT PAGE)
2	2
3	3
4	4
5	5
6	6
7	7
8	8
9	9	REFERENCE TITLE: essential drugs; price increases; limits
10	10	State of Arizona House of Representatives Fifty-seventh Legislature First Regular Session 2025
11	11	HB 2757
12	12	Introduced by Representatives Mathis: Cavero, Crews, De Los Santos, Gutierrez, Villegas
13	13
14	14	REFERENCE TITLE: essential drugs; price increases; limits
15	15
16	16
17	17
18	18
19	19
20	20
21	21
22	22
23	23
24	24	State of Arizona
25	25
26	26	House of Representatives
27	27
28	28	Fifty-seventh Legislature
29	29
30	30	First Regular Session
31	31
32	32	2025
33	33
34	34
35	35
36	36
37	37
38	38	HB 2757
39	39
40	40
41	41
42	42	Introduced by
43	43
44	44	Representatives Mathis: Cavero, Crews, De Los Santos, Gutierrez, Villegas
45	45
46	46
47	47
48	48
49	49
50	50
51	51
52	52
53	53
54	54
55	55
56	56
57	57
58	58
59	59
60	60
61	61
62	62	AN ACT
63	63
64	64
65	65
66	66	amending title 36, Arizona Revised Statutes, by adding chapter 42; relating to prescription drugs.
67	67
68	68
69	69
70	70
71	71
72	72	(TEXT OF BILL BEGINS ON NEXT PAGE)
73	73
74	74
75	75
76	76	Be it enacted by the Legislature of the State of Arizona: Section 1. Title 36, Arizona Revised Statutes, is amended by adding chapter 42, to read: CHAPTER 42 PRESCRIPTION DRUGS ARTICLE 1. PRICING START_STATUTE36-4201. Definitions In this article, unless the context otherwise requires: 1. "Essential off-patent or generic drug": (a) Means any prescription drug that meets all of the following: (i) All exclusive marketing rights, if any, granted under the federal food, drug, and cosmetic act, section 351 of the federal public health service act, and federal patent law have expired. (ii) Either appears on the model list of essential medicines most recently adopted by the world health organization or has been designated by the secretary of the United States department of health and human services as an essential medicine due to its efficacy in treating a life-threatening health condition or a chronic health condition that substantially impairs an individual's ability to engage in activities of daily living. (iii) Is actively manufactured and marketed for sale in the United States by three or fewer manufacturers. (iv) Is made available for sale in this state. (b) Includes any drug-device combination product used to deliver a drug for which all exclusive marketing rights, if any, granted under the federal food, drug, and cosmetic act, section 351 of the federal public health service act, and federal patent law have expired. 2. "Price gouging" means an unconscionable increase in the price of a prescription drug. 3. "State medical assistance program" means the Arizona health care cost containment system established by chapter 29 of this title. 4. "Unconscionable increase" means an increase in the price of a prescription drug that both: (a) Is excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health. (b) Results in consumers for whom the drug has been prescribed having no meaningful choice about whether to purchase the drug at an excessive price because of the importance of the drug to the consumer's health and insufficient competition in the market for the drug. 5. "Wholesale acquisition cost" has the same meaning prescribed in 42 United States code section 1395w3a.END_STATUTE START_STATUTE36-4202. Manufacturers; wholesale distributors; price gouging prohibited A. A manufacturer or wholesale distributor may not engage in price gouging in the sale of an essential off-patent or generic drug. B. It is not a violation of subsection A of this section for a wholesale distributor to increase the price of an essential off-patent or generic drug if the price increase is directly attributable to additional costs for the essential off-patent or generic drug imposed on the wholesale distributor by the manufacturer of the essential off-patent or generic drug. END_STATUTE START_STATUTE36-4203. Attorney general; information required; enforcement actions; civil penalty; confidentiality A. The state medical assistance program may notify the attorney general of any increase in the price of an essential off-patent or generic drug if both of the following apply: 1. The price increase, by itself or in combination with other price increases, would result in an increase of at least fifty percent in either: (a) The wholesale acquisition cost of the essential off-patent or generic drug within the preceding one-year period. (b) The price paid by the state medical assistance program for the essential off-patent or generic drug within the preceding one-year period. 2. One of the following applies: (a) A thirty-day supply of the maximum recommended dosage of the essential off-patent or generic drug for any indication, according to the label for the essential off-patent or generic drug approved under the federal food, drug, and cosmetic act, would cost more than $80 at the essential off-patent or generic drug's wholesale acquisition cost. (b) A full course of treatment with the essential off-patent or generic drug, according to the label for the essential off-patent or generic drug approved under the federal food, drug, and cosmetic act, would cost more than $80 at the essential off-patent or generic drug's wholesale acquisition cost. (c) The essential off-patent or generic drug is made available to consumers only in quantities that do not correspond to a thirty-day supply, a full course of treatment or a single dose and would cost more than $80 at the essential off-patent or generic drug's wholesale acquisition cost to obtain a thirtyday supply or a full course of treatment. B. On request of the attorney general, the manufacturer of an essential off-patent or generic drug identified in a notice under subsection A of this section, within forty-five days after the request, shall submit a statement to the attorney general that does all of the following: 1. Itemizes the components of the cost of producing the essential off-patent or generic drug and identifies the circumstances and timing of any increase in materials or manufacturing costs that caused any increase in the price of the essential off-patent or generic drug within the one-year period preceding the date of the price increase. 2. Identifies the circumstances and timing of any expenditures made by the manufacturer to expand access to the essential off-patent or generic drug and explains any improvement in public health associated with those expenditures. 3. Provides any other information that the manufacturer believes to be relevant to determining whether a violation of this article has occurred. C. The attorney general may require a manufacturer or a wholesale distributor of an essential off-patent or generic drug to produce any records or other documents that may be relevant to a determination of whether a violation of this article has occurred. D. On petition of the attorney general and subject to subsection E of this section, a superior court may issue an order: 1. Compelling a manufacturer or a wholesale distributor of an essential off-patent or generic drug to provide the statement required under subsection B of this section and to produce specific records or other documents requested by the attorney general under subsection C of this section that may be relevant to determining whether a violation of this article has occurred. 2. Restraining or enjoining a violation of this article. 3. Restoring to any consumer, including a third-party payor, any monies acquired as a result of a price increase that violates this article. 4. Requiring a manufacturer that has engaged in price gouging in the sale of an essential off-patent or generic drug to make the essential off-patent or generic drug available to participants in the state medical assistance program for a period of up to one year at the price at which the essential off-patent or generic drug was made available to participants immediately before the manufacturer's violation of this article. 5. Imposing a civil penalty of up to $10,000 for each violation of this article. E. The attorney general may not bring an action for a remedy under subsection D, paragraph 2, 3, 4 or 5 of this section unless the attorney general has provided the manufacturer or wholesale distributor of an essential off-patent or generic drug with an opportunity to meet with the attorney general to offer a justification for the increase in the price of the essential off-patent or generic drug. F. Any information provided by a manufacturer or a wholesale distributor of an essential off-patent or generic drug to the attorney general under subsections B and C of this section is considered confidential commercial information unless the confidentiality of the information is waived by the manufacturer or wholesale distributor. G. In any action brought by the attorney general under subsection D of this section, a person who is alleged to have violated a requirement of this article may not assert as a defense that the person did not deal directly with a consumer residing in this state. END_STATUTE
77	77
78	78	Be it enacted by the Legislature of the State of Arizona:
79	79
80	80	Section 1. Title 36, Arizona Revised Statutes, is amended by adding chapter 42, to read:
81	81
82	82	CHAPTER 42
83	83
84	84	PRESCRIPTION DRUGS
85	85
86	86	ARTICLE 1. PRICING
87	87
88	88	START_STATUTE36-4201. Definitions
89	89
90	90	In this article, unless the context otherwise requires:
91	91
92	92	1. "Essential off-patent or generic drug":
93	93
94	94	(a) Means any prescription drug that meets all of the following:
95	95
96	96	(i) All exclusive marketing rights, if any, granted under the federal food, drug, and cosmetic act, section 351 of the federal public health service act, and federal patent law have expired.
97	97
98	98	(ii) Either appears on the model list of essential medicines most recently adopted by the world health organization or has been designated by the secretary of the United States department of health and human services as an essential medicine due to its efficacy in treating a life-threatening health condition or a chronic health condition that substantially impairs an individual's ability to engage in activities of daily living.
99	99
100	100	(iii) Is actively manufactured and marketed for sale in the United States by three or fewer manufacturers.
101	101
102	102	(iv) Is made available for sale in this state.
103	103
104	104	(b) Includes any drug-device combination product used to deliver a drug for which all exclusive marketing rights, if any, granted under the federal food, drug, and cosmetic act, section 351 of the federal public health service act, and federal patent law have expired.
105	105
106	106	2. "Price gouging" means an unconscionable increase in the price of a prescription drug.
107	107
108	108	3. "State medical assistance program" means the Arizona health care cost containment system established by chapter 29 of this title.
109	109
110	110	4. "Unconscionable increase" means an increase in the price of a prescription drug that both:
111	111
112	112	(a) Is excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health.
113	113
114	114	(b) Results in consumers for whom the drug has been prescribed having no meaningful choice about whether to purchase the drug at an excessive price because of the importance of the drug to the consumer's health and insufficient competition in the market for the drug.
115	115
116	116	5. "Wholesale acquisition cost" has the same meaning prescribed in 42 United States code section 1395w3a.END_STATUTE
117	117
118	118	START_STATUTE36-4202. Manufacturers; wholesale distributors; price gouging prohibited
119	119
120	120	A. A manufacturer or wholesale distributor may not engage in price gouging in the sale of an essential off-patent or generic drug.
121	121
122	122	B. It is not a violation of subsection A of this section for a wholesale distributor to increase the price of an essential off-patent or generic drug if the price increase is directly attributable to additional costs for the essential off-patent or generic drug imposed on the wholesale distributor by the manufacturer of the essential off-patent or generic drug. END_STATUTE
123	123
124	124	START_STATUTE36-4203. Attorney general; information required; enforcement actions; civil penalty; confidentiality
125	125
126	126	A. The state medical assistance program may notify the attorney general of any increase in the price of an essential off-patent or generic drug if both of the following apply:
127	127
128	128	1. The price increase, by itself or in combination with other price increases, would result in an increase of at least fifty percent in either:
129	129
130	130	(a) The wholesale acquisition cost of the essential off-patent or generic drug within the preceding one-year period.
131	131
132	132	(b) The price paid by the state medical assistance program for the essential off-patent or generic drug within the preceding one-year period.
133	133
134	134	2. One of the following applies:
135	135
136	136	(a) A thirty-day supply of the maximum recommended dosage of the essential off-patent or generic drug for any indication, according to the label for the essential off-patent or generic drug approved under the federal food, drug, and cosmetic act, would cost more than $80 at the essential off-patent or generic drug's wholesale acquisition cost.
137	137
138	138	(b) A full course of treatment with the essential off-patent or generic drug, according to the label for the essential off-patent or generic drug approved under the federal food, drug, and cosmetic act, would cost more than $80 at the essential off-patent or generic drug's wholesale acquisition cost.
139	139
140	140	(c) The essential off-patent or generic drug is made available to consumers only in quantities that do not correspond to a thirty-day supply, a full course of treatment or a single dose and would cost more than $80 at the essential off-patent or generic drug's wholesale acquisition cost to obtain a thirtyday supply or a full course of treatment.
141	141
142	142	B. On request of the attorney general, the manufacturer of an essential off-patent or generic drug identified in a notice under subsection A of this section, within forty-five days after the request, shall submit a statement to the attorney general that does all of the following:
143	143
144	144	1. Itemizes the components of the cost of producing the essential off-patent or generic drug and identifies the circumstances and timing of any increase in materials or manufacturing costs that caused any increase in the price of the essential off-patent or generic drug within the one-year period preceding the date of the price increase.
145	145
146	146	2. Identifies the circumstances and timing of any expenditures made by the manufacturer to expand access to the essential off-patent or generic drug and explains any improvement in public health associated with those expenditures.
147	147
148	148	3. Provides any other information that the manufacturer believes to be relevant to determining whether a violation of this article has occurred.
149	149
150	150	C. The attorney general may require a manufacturer or a wholesale distributor of an essential off-patent or generic drug to produce any records or other documents that may be relevant to a determination of whether a violation of this article has occurred.
151	151
152	152	D. On petition of the attorney general and subject to subsection E of this section, a superior court may issue an order:
153	153
154	154	1. Compelling a manufacturer or a wholesale distributor of an essential off-patent or generic drug to provide the statement required under subsection B of this section and to produce specific records or other documents requested by the attorney general under subsection C of this section that may be relevant to determining whether a violation of this article has occurred.
155	155
156	156	2. Restraining or enjoining a violation of this article.
157	157
158	158	3. Restoring to any consumer, including a third-party payor, any monies acquired as a result of a price increase that violates this article.
159	159
160	160	4. Requiring a manufacturer that has engaged in price gouging in the sale of an essential off-patent or generic drug to make the essential off-patent or generic drug available to participants in the state medical assistance program for a period of up to one year at the price at which the essential off-patent or generic drug was made available to participants immediately before the manufacturer's violation of this article.
161	161
162	162	5. Imposing a civil penalty of up to $10,000 for each violation of this article.
163	163
164	164	E. The attorney general may not bring an action for a remedy under subsection D, paragraph 2, 3, 4 or 5 of this section unless the attorney general has provided the manufacturer or wholesale distributor of an essential off-patent or generic drug with an opportunity to meet with the attorney general to offer a justification for the increase in the price of the essential off-patent or generic drug.
165	165
166	166	F. Any information provided by a manufacturer or a wholesale distributor of an essential off-patent or generic drug to the attorney general under subsections B and C of this section is considered confidential commercial information unless the confidentiality of the information is waived by the manufacturer or wholesale distributor.
167	167
168	168	G. In any action brought by the attorney general under subsection D of this section, a person who is alleged to have violated a requirement of this article may not assert as a defense that the person did not deal directly with a consumer residing in this state. END_STATUTE