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Full Text of HB4469
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HB4469 - 104th General Assembly
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104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026
HB4469
Introduced 1/20/2026, by Rep. Hoan Huynh
SYNOPSIS AS INTRODUCED:
New Act
Creates the Illinois Affordable Drug Manufacturing Act. Provides that
the Department of Human Services shall enter into partnerships with drug
companies or manufactures to: (i) increase competition, lower prices, and
address shortages in the market for generic prescription drugs; (ii)
reduce the cost of prescription drugs for public and private purchasers,
taxpayers, and consumers; and (iii) increase patient access to affordable
drugs. Provides that such partnerships shall be made with the intent to
ensure the wide availability of generic prescription drugs to public and
private purchasers, providers and suppliers, and pharmacies as
appropriate. Requires that such drugs must be produced or distributed by a
drug company or generic drug manufacturer that is registered with the
United States Food and Drug Administration. Sets forth price setting
criteria and a list of the most common generic prescription drugs that are
to be produced and distributed through the partnerships. Requires the
Department to consult with other State agencies, licensed health care
service plans, health insurers, hospitals, and pharmacy benefit managers
in maintaining the list of generic prescription drugs. Contains provisions
concerning minimum drug procurement thresholds; reporting requirements;
and other matters. Makes implementation of the Act subject to
appropriation. Effective immediately, except that certain provisions take
effect on January 1, 2029.
LRB104 15174 KTG 28318 b
A BILL FOR
HB4469
LRB104 15174 KTG 28318 b
1
AN ACT concerning State government.
2
Be it enacted by the People of the State of Illinois,
3
represented in the General Assembly:
4
Section 1.
Short title.
This Act may be cited as the
5
Illinois Affordable Drug Manufacturing Act.
6
Section 5.
Definitions.
As used in this Act:
7
"Department" means the Department of Human Services.
8
"Generic drug" means a drug that is approved in accordance
9
with subdivision (j) of Section 355 of the Federal Food, Drug,
10
and Cosmetic Act (21 U.S.C. 301 et seq.), or a biosimilar, as
11
defined under the federal Public Health Service Act (42 U.S.C.
12
262).
13
"Partnerships" include, but are not limited to, agreements
14
for the procurement of generic prescription drugs by way of
15
contracts or purchasing by a payer, State governmental agency,
16
group purchasing organization, nonprofit organization, or
17
other entity.
18
"Pharmacy" or "drugstore" means every store, shop,
19
pharmacy department, or any other place where pharmacist care
20
is provided by a pharmacist:
21
(1) where drugs, medicines, or poisons are dispensed,
22
sold or offered for sale at retail, or displayed for sale
23
at retail; or
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(2) where prescriptions of physicians, dentists,
2
advanced practice registered nurses, physician assistants,
3
veterinarians, podiatric physicians, or optometrists,
4
within the limits of their licenses, are compounded,
5
filled, or dispensed; or
6
(3) which has upon it or displayed within it, or
7
affixed to or used in connection with it, a sign bearing
8
the word or words "Pharmacist", "Druggist", "Pharmacy",
9
"Pharmaceutical Care", "Apothecary", "Drugstore",
10
"Medicine Store", "Prescriptions", "Drugs", "Dispensary",
11
"Medicines", or any word or words of similar or like
12
import, either in the English language or any other
13
language; or
14
(4) where the characteristic prescription sign (Rx) or
15
similar design is exhibited.
16
"Pharmacy" or "drugstore" includes any store, or shop, or
17
other place with respect to which any of the words, objects,
18
signs, or designs listed in paragraphs (1) through (4) are
19
used in any advertisement.
20
"Provider" means a hospital, a skilled nursing facility, a
21
comprehensive outpatient rehabilitation facility, a home
22
health agency, a hospice, a clinic, or a rehabilitation
23
agency.
24
"Supplier" means a physician and surgeon or other health
25
care practitioner, or an entity that furnishes health care
26
services other than a provider.
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Section 10.
Partnership with generic drug manufactures.
2
(a) The Department shall enter into partnerships,
3
consistent with subsection (b) of Section 15, in consultation
4
with other State departments as necessary, to increase
5
competition, lower prices, and address shortages in the market
6
for generic prescription drugs, to reduce the cost of
7
prescription drugs for public and private purchasers,
8
taxpayers, and consumers, and to increase patient access to
9
affordable drugs.
10
(b) Contingent upon specific appropriation, the Department
11
shall have the ability to hire staff to oversee and
12
project-manage the partnerships for manufacturing or
13
distribution of generic prescription drugs.
14
Section 15.
Prescription drug acquisition, distribution,
15
and price setting.
16
(a) The Department shall enter into partnerships resulting
17
in the production or distribution of generic prescription
18
drugs, with the intent that these drugs be made widely
19
available to public and private purchasers, providers and
20
suppliers, and pharmacies as appropriate. The generic
21
prescription drugs shall be produced or distributed by a drug
22
company or generic drug manufacturer that is registered with
23
the United States Food and Drug Administration.
24
(b)(1) The Department shall only enter into partnerships
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as provided under subsection (a) to produce a generic
2
prescription drug at a price that results in savings, targets
3
failures in the market for generic drugs, and improves patient
4
access to affordable medications.
5
(2) For top drugs identified in accordance with the
6
criteria listed in paragraph (5), the Department shall, if
7
possible, determine partnerships to manufacture or distribute
8
generic prescription drugs by examining the relevant legal,
9
market, policy, and regulatory factors.
10
(3) The Department shall consider the following, if
11
applicable, when setting the price of the generic prescription
12
drug:
13
(A) United States Food and Drug Administration user
14
fees.
15
(B) Abbreviated new drug application acquisition costs
16
amortized over a 5-year period.
17
(C) Mandatory rebates.
18
(D) Total contracting and production costs for the
19
drug, including a reasonable amount for administrative,
20
operating, and rate-of-return expenses of the drug company
21
or generic drug manufacturer.
22
(E) Research and development costs attributed to the
23
drug over a 5-year period.
24
(F) Other initial start-up costs amortized over a
25
5-year period.
26
(4) Each drug shall be made available to providers,
HB4469
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patients, and purchasers at a transparent price and without
2
rebates, other than federally required rebates.
3
(5) The Department shall prioritize the selection of
4
generic prescription drugs that have the greatest impact on
5
lowering drug costs to patients, increasing competition and
6
addressing shortages in the prescription drug market,
7
improving public health, or reducing the cost of prescription
8
drugs to public and private purchasers.
9
(c) The top 100 of the most common generic prescription
10
drugs as of August 31, 2025, per the National Library of
11
Medicine 2025 report, are to be produced and include the
12
following:
13
Lisinopril, Levothyroxine, Metformin, Simvastatin,
14
Omeprazole, Amlodipine Besylate, Metoprolol,
15
Acetaminophen (Hydrocodone), Albuterol,
16
Hydrochlorothiazide, Losartan, Gabapentin, Sertraline,
17
Furosemide, Acetaminophen Analgesic, Atenolol,
18
Pravastatin, Amoxicillin, Fluoxetine, Citalopram,
19
Trazodone, Alprazolam, Fluticasone, Bupropion,
20
Carvedilol, Potassium Chloride, Tramadol, Pantoprazole,
21
Montelukast, Escitalopram, Prednisone, Rosuvastatin,
22
Ibuprofen, Meloxicam, Insulin Glargine,
23
Hydrochlorothiazide & Lisinopril, Clonazepam, Aspirin,
24
Clopidogrel Antiplatelet, Glipizide, Warfarin
25
Anticoagulant, Cyclobenzaprine, Insulin Human,
26
Tamsulosin, Zolpidem, Ethinyl Estradiol/ Norgestimate,
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Duloxetine, Ranitidine, Venlafaxine, Fluticasone
2
Salmeterol, Oxycodone, Azithromycin, Amphetamine,
3
Lorazepam, Allopurinol, Paroxetine, Methylphenidate,
4
Estradiol, Hydrochlorothiazide & Losartan K, Ethinyl
5
Estradiol/ Norethindrone, Fenofibrate, Propanolol,
6
Glimepiride, Ergocalciferol, Esomeprazole,
7
Spironolactone, Loratadine, Naproxen, Lamotrigine,
8
Hydrochlorothiazide/ Triamterene, Cetirizine,
9
Sulfamethoxazole (Trimethoprim), Lovastatin, Diltiazem,
10
Clonidine, Topiramate, Amoxicillin, Pregabalin, Folic
11
Acid, Aldendronate Sodium, Hydrocodone Bitrate,
12
Amitriptyline, Diclofenac, Insulin Aspart, Tiotropium,
13
Quetiapine Fumarate, Enalapril, Polymyxin B Sulfate,
14
Sitagliptin Phosphate, Diazepam, Latanoprost,
15
Ciprofloxacin, Budesonide (Formoterol), Hydroxyzine,
16
Ethinyl Estradiol (Levonorgestrel), Docusate, Valsartan,
17
Finasteride, Ondansetron.
18
The top 100 of the most common generic drugs to be produced
19
under this Act shall be updated every 5 years, starting in
20
2030, per the National Library of Medicine.
21
(d) The Department shall consult with all of the following
22
public and private purchasers to assist in developing a list
23
of generic prescription drugs to be manufactured or
24
distributed through partnerships and to determine the volume
25
of each generic prescription drug that can be procured over a
26
multiyear period to support a market for a lower cost generic
HB4469
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LRB104 15174 KTG 28318 b
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prescription drug:
2
(1) The Department of Healthcare and Family Services,
3
the Illinois health insurance marketplace, the Department
4
of Public Health, and the Department of Central Management
5
Services, or the entities acting on behalf of each of
6
those State purchasers.
7
(2) Licensed health care service plans.
8
(3) Health insurers holding a valid outstanding
9
certificate of authority from the Director of Insurance.
10
(4) Hospitals.
11
(5) Pharmacy benefit managers.
12
(e) Before effectuating a partnership in accordance with
13
this Section, the Department shall determine minimum
14
thresholds for procurement of an entity's expected volume of a
15
targeted drug from the company or manufacturer over a
16
multiyear period. In making advance commitments, the
17
Department shall consult with the Department of Central
18
Management Services.
19
(f) The listed entities in paragraphs (2) through (5) of
20
subsection (d) shall not be required to purchase prescription
21
drugs from the Department or entities that contract or partner
22
with the Department in accordance with this Act.
23
(g) The Department shall not be required to consult with
24
every entity listed in paragraphs (2) through (5) of
25
subsection (d), so long as purchaser engagement includes a
26
reasonable representation from these groups.
HB4469
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Section 20.
Report.
2
(a) On or before July 1, 2028, the Department shall report
3
to the General Assembly on the following:
4
(1) The feasibility of directly manufacturing generic
5
prescription drugs and selling generic prescription drugs
6
at a fair price.
7
(2) An analysis of governance structure options for
8
manufacturing functions, including chartering a private
9
organization, a public-private partnership, or a public
10
board of directors.
11
(3) A description of the status of all drugs targeted
12
under this Act.
13
(4) An analysis of how the activities of the
14
Department may impact competition, access to targeted
15
drugs, the costs of those drugs, and the costs of generic
16
prescription drugs to public and private purchasers.
17
(5) An analysis of viable pathways for partnerships to
18
manufacture or distribute generic prescription drugs by
19
examining the relevant legal, market, policy, and
20
regulatory factors.
21
(b) This Section is repealed on January 1, 2029.
22
Section 25.
Funding.
Implementation of this Act is subject
23
to appropriation.
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LRB104 15174 KTG 28318 b
1
Section 97.
Severability.
If any provision of this Act or
2
its application to any person or circumstance is held invalid,
3
the invalidity of that provision or application does not
4
affect other provisions or applications of this Act that can
5
be given effect without the invalid provision or application.
6
Section 99.
Effective date.
This Act takes effect upon
7
becoming law, except that Section 15 takes effect on January
8
1, 2029.
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