101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
HB0053

 

Introduced 1/9/2019, by Rep. Mary E. Flowers

 

SYNOPSIS AS INTRODUCED:
 
410 ILCS 620/16.2 new
410 ILCS 620/16.3 new

    Amends the Illinois Food, Drug and Cosmetic Act. Requires manufacturers of brand name or generic prescription drugs to notify State purchasers, health insurers, health care service plan providers, pharmacy benefit managers, and the General Assembly of specified increases in drug prices at least 60 days before such increase and the cost of specified new prescription drugs within 3 days after approval by the U.S. Food and Drug Administration. Provides that within 30 days after such notifications, prescription drug manufacturers shall report specified information to State purchasers, health insurers, health care service plan providers, pharmacy benefit managers, and the General Assembly. Provides that failure to report such information shall result in a specified civil penalty. Requires the General Assembly to conduct an annual public hearing on aggregate trends in prescription drug pricing. Provides that if the manufacturer of a prescription drug or its agent meets or otherwise communicates with a prescriber for the purpose of marketing a drug, then the manufacturer or its agent shall disclose to the prescriber if any ingredient in the drug it is marketing is known to pose a risk of dependency in humans. Makes other changes.


LRB101 04687 CPF 49696 b

FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB0053LRB101 04687 CPF 49696 b

1    AN ACT concerning health.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Illinois Food, Drug and Cosmetic Act is
5amended by adding Sections 16.2 and 16.3 as follows:
 
6    (410 ILCS 620/16.2 new)
7    Sec. 16.2. Prescription drug price increases.
8    (a) This Section shall apply to any manufacturer of a
9prescription drug that is purchased or reimbursed by any of the
10following:
11        (1) A State purchaser, including, but not limited to,
12    State retirement systems, the Department of Corrections,
13    the Department of Healthcare and Family Services, the
14    Department of Public Health, or any entity acting on behalf
15    of a State purchaser.
16        (2) A health insurer.
17        (3) A health care service plan provider.
18        (4) A pharmacy benefit manager.
19    (b) A manufacturer of a brand name prescription drug shall
20provide written notice to State purchasers, health insurers,
21health care service plan providers, pharmacy benefit managers,
22and the General Assembly if the manufacturer is increasing the
23wholesale price of the brand name prescription drug by more

 

 

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1than 10% during a 12-month period or by more than $10,000
2during a 12-month period. A manufacturer of a generic
3prescription drug with a wholesale price of $100 or more per
430-day month shall provide written notice to State purchasers,
5health insurers, health care service plan providers, pharmacy
6benefit managers, and the General Assembly if the manufacturer
7is increasing the wholesale price of the generic prescription
8drug by more than 25% during a 12-month period. The notice
9shall be provided in writing at least 60 days prior to the
10planned effective date of the increase. Within 30 days after
11notification of a price increase as provided in this
12subsection, a manufacturer shall report the following
13information to State purchasers, health insurers, health care
14service plan providers, pharmacy benefit managers, and the
15General Assembly:
16        (1) a justification for the proposed price increase;
17    the manufacturer may limit the information in the
18    justification to that which is publicly available;
19        (2) the previous year's marketing budget for the drug;
20        (3) the date and price of acquisition if the drug was
21    not developed by the manufacturer; and
22        (4) a schedule of price increases for the drug for the
23    previous 5 years.
24    (c) A manufacturer of a prescription drug shall provide
25written notice to State purchasers, health insurers, health
26care service plan providers, pharmacy benefit managers, and the

 

 

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1General Assembly if the manufacturer is introducing a new
2prescription drug to market at a wholesale cost of $10,000 or
3more annually or per course of treatment. The notice shall be
4provided in writing within 3 days after approval by the U.S.
5Food and Drug Administration. Within 30 days after notification
6of approval for a new drug as provided in this subsection, a
7manufacturer shall report the following information to State
8purchasers, health insurers, health care service plan
9providers, pharmacy benefit managers, and the General
10Assembly:
11        (1) a justification for the introductory price; the
12    manufacturer may limit the contents of the justification to
13    publicly available information;
14        (2) the expected marketing budget for the drug; and
15        (3) the date and price of acquisition if the drug was
16    not developed by the manufacturer.
17    (d) Failure to report the information required pursuant to
18subsection (b) or subsection (c) to State purchasers, health
19insurers, health care service plan providers, pharmacy benefit
20managers, or the General Assembly shall result in a civil
21penalty of $1,000 per day for every day after the 30-day
22notification period.
23    (e) The General Assembly shall conduct an annual public
24hearing on aggregate trends in prescription drug pricing. The
25hearing shall provide for public discussion of overall price
26increases, emerging trends, decreases in drug spending, and the

 

 

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1impact of prescription drug spending on health care
2affordability and premiums.
3    (f) Except for the hearing required pursuant to subsection
4(e), the General Assembly shall keep confidential all of the
5information provided to the General Assembly pursuant to this
6Section, and that information shall be exempt from disclosure
7under the Freedom of Information Act.
8    (g) This Section shall not restrict the legal ability of a
9pharmaceutical manufacturer to change prices as permitted
10under federal law.
 
11    (410 ILCS 620/16.3 new)
12    Sec. 16.3. Prescription drug manufacturer disclosure of
13dependency risk. If the manufacturer of a prescription drug or
14its agent meets or otherwise communicates with a prescriber for
15the purpose of marketing a drug, then the manufacturer or its
16agent shall disclose to the prescriber if any ingredient in the
17drug it is marketing is known to pose a risk of dependency in
18humans. For the purposes of this subsection, "prescriber" shall
19have the same meaning as provided in the Illinois Controlled
20Substances Act.