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A4184
ASSEMBLY, No. 4184
STATE OF NEW JERSEY
222nd LEGISLATURE
�
INTRODUCED FEBRUARY 19, 2026
Sponsored by:
Assemblywoman� CAROL A. MURPHY
District 7 (Burlington)
SYNOPSIS
���� Prohibits excessive increases in prices charged for
essential off-patent and generic prescription drugs and biological products.
CURRENT VERSION OF TEXT
���� As introduced.
��
An Act
concerning pharmaceutical pricing and
supplementing Title 24 of the Revised Statutes.
����
Be It
Enacted
by the Senate and General Assembly of
the State of New Jersey:
���� 1.��� As used in P.L.��� ,
c.��� (C.������� ) (pending before the Legislature as this bill):
���� �Director� means the Director
of the Division of Consumer Affairs in the Department of Law and Public Safety.
���� �Division� means the Division
of Consumer Affairs in the Department of Law and Public Safety.
���� �Essential off-patent or
generic drug or biological product� means any prescription drug or biological
product, including any drug-device or biological product-device combination
product for the delivery of the prescription drug or biological product:
���� (1)�� that is made available
for sale in the State;
���� (2)�� for which all exclusive
marketing rights, if any, granted under the 52 Stat. 1040, 21 U.S.C. s.301 et
seq., section 351 of the "Public Health Service Act," 58 Stat. 682,
42 U.S.C. s.262, and federal patent law, have expired;
���� (3)�� that is actively
manufactured and marketed by three or fewer manufacturers; and
���� (4)�� that appears on the
current Model List of Essential Medicines adopted by the World Health
Organization or has been designated by the Commissioner of Health as an
essential medicine due to its efficacy in treating a life-threatening health
condition or a chronic health condition that substantially impairs a person�s
ability to engage in activities of daily living.
���� �FDA� means the federal Food
and Drug Administration.
���� �Price gouging� means any
unconscionable increase in the price of a prescription drug or biological
product.
���� �Unconscionable increase�
means an increase in the price of a prescription drug or biological product
that:
���� (1)�� is excessive and not
justified by the cost of producing the drug or biological product or the cost
of appropriate expansion of access to the drug or biological product to promote
the public health; and
���� (2)�� results in consumers for
whom the drug or biological product has been prescribed having no alternative
but to purchase the drug or biological product at an excessive price because of
the importance of the drug to the health of the consumers and insufficient
competition in the market for the drug or biological product.
���� �Wholesale acquisition cost�
means
, with respect to a drug
or
biological product
, the manufacturer's list
price for the drug
or biological product
to wholesalers or direct purchasers in the United States, not including
prompt pay or other discounts, rebates, or reductions in price, for the most
recent month for which the information is available, as reported in wholesale
price guides or other publications of drug
or biological product
pricing data.
���� 2.��� a.� A prescription drug
or biological product manufacturer or wholesale distributor shall not engage in
price gouging in the sale of an essential off-patent or generic drug or
biological product.�
���� �b.�� It shall not constitute
a violation of subsection a. of this section for a wholesale distributor to
increase the price of an essential off-patent or generic drug or biological
product if the price increase is directly attributable to additional costs for
the drug or biological product imposed on the wholesale distributor by the
manufacturer of the drug or biological product.
���� 3.��� a.� The director may
notify the Attorney General of any increase in the price of an essential
off-patent or generic drug or biological product whenever:
���� (1)�� the price increase,
individually or in combination with other price increases:
���� (a)�� would result in an
increase of 50 percent or more in the wholesale acquisition cost of the drug or
biological product within the preceding one-year period; or
���� (b)�� would result in an
increase of 50 percent or more in the price paid by the Medicaid program or NJ
FamilyCare program for the drug or biological product within the preceding
one-year period, as certified by the Director of the Division of Medical
Assistance and Health Services in the Department of Human Services; and
���� (2)�� (a)� a 30-day supply of
the maximum recommended dosage of the drug or biological product for any
indication, according to the FDA-approved label for the drug or biological
product, would cost more than $80 at the wholesale acquisition cost of the drug
or biological product;
���� (b)�� a full course of
treatment with the drug or biological product, according to the FDA-approved
label for the drug or biological product, would cost more than $80 at the
wholesale acquisition cost of the drug or biological product; or
���� (c)�� if the drug or
biological product is made available to consumers only in quantities that do
not correspond to a 30-day supply, a full course of treatment, or a single
dose, the drug or biological product would cost more than $80 at the wholesale
acquisition cost of the drug or biological product to obtain a 30-day supply or
a full course of treatment.
���� b.��� At the request of the
Attorney General, the manufacturer of an essential off-patent or generic drug
or biological product identified in a notice provided pursuant to subsection a.
of this section shall, no later than 45 days after receipt of the request,
submit a statement to the Attorney General:
���� (1)�� itemizing the components
of the cost of producing the drug or biological product;
���� (2)�� identifying the
circumstances and timing of any increase in materials or manufacturing costs
that caused any increase in the price of the drug or biological product within
the one-year period preceding the date of the price increase;
���� (3)�� identifying the
circumstances and timing of any expenditures made by the manufacturer to expand
access to the drug or biological product and explaining any improvement in
public health associated with those expenditures; and
���� (4)�� providing any other
information that the manufacturer believes to be relevant to a determination as
to whether a violation of P.L.��� , c.��� (C.������� ) (pending before the
Legislature as this bill) has occurred.
���� �c.��� The Attorney General
may require a manufacturer or a wholesale distributor to produce any records or
documents that may be relevant to a determination as to whether a violation of
P.L. , c. (C. ) (pending
before the Legislature as this bill) has occurred.
���� d.��� Upon petition of the
Attorney General, a court may issue an order:
���� (1)�� compelling a
manufacturer to submit the statement required pursuant to subsection b. of this
section or a manufacturer or wholesale distributor to produce specific records
or documents as requested by the Attorney General pursuant to subsection c. of
this section;
���� (2)�� restraining or enjoining
a violation of P.L.��� , c.��� (C.������� ) (pending before the Legislature as
this bill);
���� (3)�� restoring to any
consumer, including any third party payor, any money acquired by a manufacturer
or wholesale distributor as a result of a price increase that violates P.L.���
, c.��� (C.������� ) (pending before the Legislature as this bill);
���� (4)�� requiring a manufacturer
that has engaged in price gouging in the sale of an essential off-patent or
generic drug or biological product to make the drug or biological product
available to wholesale distributors, pharmacies, and consumers in the State, for
a period of up to one year, at a price that does not exceed the price at which
the drug or biological product was made available to such wholesale
distributors, pharmacies, and consumers immediately prior to the violation of
P.L.��� , c.��� (C.������� ) (pending before the Legislature as this bill); and
���� (5)�� assessing a civil
penalty of up to $10,000 against a manufacturer or wholesale distributor for
each violation of
P.L. , c. (C. ) (pending
before the Legislature as this bill).� For the purposes of this paragraph, each
sale of an essential off-patent or generic drug or biological product at a
price that constitutes price gouging shall be deemed to be a separate
violation.
���� e.���� The Attorney General
shall not commence an action seeking relief pursuant to paragraphs (2) through
(5) of subsection d. of this section unless the Attorney General has provided
the manufacturer or wholesale distributor an opportunity to meet with the Attorney
General to provide a justification for the increase in the price of the
essential off-patent or generic drug or biological product.
���� f.���� Any information
provided by a manufacturer pursuant to subsection b. of this section, or by a
manufacturer or wholesale distributor pursuant to subsection c. of this
section, shall be deemed confidential and shall not be disclosed to the public
or otherwise subject to public access, inspection, or copying, unless such
confidentiality is waived by the manufacturer or wholesale distributor.
���� g.��� It shall not be a
defense to an action brought by the Attorney General pursuant to subsection d.
of this section that a manufacturer alleged to have violated P.L.��� , c.���
(C.������� ) (pending before the Legislature as this bill) did not sell the
essential off-patent or generic drug or biological product directly to a
consumer in this State.
���� 4.��� The Director of the
Division of Consumer Affairs in the Department of Law and Public Safety shall,
pursuant to the �Administrative Procedure Act,� P.L.1968, c.410
(C.52:14B-1 et seq.) adopt such rules and regulations as shall
be necessary to implement the provisions of this act.
���� 5.��� This act shall take
effect the first day of the seventh month next following the date of enactment,
except that the Director of the Division of Consumer Affairs in the Department
of Law and Public Safety may take any advance administrative action as may be
necessary to implement the provisions of this act.
STATEMENT
���� This bill prohibits
manufacturers and wholesale distributors of prescription drugs biological
products from excessively increasing the price of certain prescription drugs
and biological products without justification.
���� Specifically, manufacturers
and wholesale distributors may not engage in price gouging in the sale of an
essential off-patent or generic drug or biological product.� Price gouging is
defined to mean an increase in the price of a drug or biological product that:�
(1) is excessive and not justified by the cost of producing the drug or
biological product or expanding access to the drug or biological product to
promote the public health; and (2) results in consumers having no alternative
but to purchase the drug or biological product at an excessive price because of
the importance of the drug or biological product to their health and
insufficient marketplace competition.� Under the bill, wholesale distributors
will not be found to have violated this prohibition if the distributor
increases the price of a drug or biological product in direct response to
additional costs for the drug or biological product imposed on the distributor
by the manufacturer.
���� The bill defines �essential
off-patent or generic drug or biological product� to mean any prescription drug
or biological product, including any drug-device or biological product-device
combination product for the delivery of the prescription drug or biological
product:� (1) that is made available for sale in the State; (2) for which all
exclusive marketing rights granted under federal law have expired; (3) that is
actively manufactured and marketed by three or fewer manufacturers; and (4)
that appears on the current Model List of Essential Medicines adopted by the
World Health Organization or has been otherwise designated as an essential
medicine by the Commissioner of Health.
���� The Director of the Division
of Consumer Affairs in the Department of Law and Public Safety may notify the
Attorney General of any increase in the price of an essential off-patent or
generic drug or biological product whenever:� (1) the price increase, individually
or in combination with other price increases, would result in an increase of 50
percent or more in the wholesale acquisition cost for the drug or biological
product or in the price paid for the drug or biological product by the State
Medicaid or NJ FamilyCare programs within a one-year period; and (2) the
wholesale acquisition cost of the drug or biological product is more than $80
for a 30-day supply or a full course of treatment.
���� At the request of the Attorney
General, the manufacturer of an essential off-patent or generic drug or
biological product identified in a notice provided under the bill will be
required to submit, within 45 days of receiving the request, a statement to the
Attorney General:� (1) detailing the cost of producing the drug or biological
product; (2) identifying the circumstances and timing of any cost increases in
the preceding year; (3) identifying the circumstances and timing of any
expenditures made by the manufacturer to expand access to the drug or
biological product, and explaining any resulting improvements in public health;
and (4) any other information the manufacturer determines to be relevant to a
determination as to whether a violation of the provisions of the bill has
occurred.
���� The Attorney General may
require a manufacturer or a wholesale distributor to produce any records or
documents that may be relevant to a determination as to whether a violation of
the bill has occurred.� The Attorney General may additionally petition for a
court order compelling submission of any required statement or records;
restraining or enjoining a violation of the bill; restoring to any consumer,
including any third party payor, any money acquired by the manufacturer or
wholesale distributor as a result of a price increase that violates the bill;
requiring a manufacturer that has engaged in price gouging to make the drug or
biological product available in the State, for a period of up to one year, at a
price that does not exceed the price immediately prior to the violation; and
assessing a civil penalty of up to $10,000 against a manufacturer or wholesale
distributor who has violated the provisions of the bill.� For the purposes of
assessing the civil penalty, each sale of a drug or biological product at a
price that constitutes price gouging will be deemed a separate violation.� It
will not be a defense to an action brought by the Attorney General that a
manufacturer did not sell the essential off-patent or generic drug or
biological product directly to a consumer in New Jersey.
���� The Attorney General may not
commence an action seeking a court order for any relief, other than an order
compelling submission of required statements or records, unless the Attorney
General has provided the manufacturer or wholesale distributor the opportunity
to meet with the Attorney General to provide a justification for the price
increase.
���� Any information provided by a
manufacturer or wholesale distributor under the bill will be confidential and may
not be disclosed to the public or otherwise subjected to public access,
inspection, or copying, unless the manufacturer or wholesale distributor waives
confidentiality.