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General Assembly Committee Bill No. 48
January Session, 2019
LCO No. 6307
Referred to Committee on GENERAL LAW
Introduced by:
(GL)
AN ACT REQUIRING MANUFA CTURERS OF BRAND NAM E
PRESCRIPTION DRUGS T O PROVIDE SAMPLES OF SUCH DRUGS
TO MANUFACTURERS OF GENERIC PRESCRIPTION DRUGS.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. (NEW) (Effective October 1, 2019) (a) As used in this 1
section: (1) "Eligible product developer" means a person who seeks to 2
develop an application for the approval of a drug under subsections 3
(b) and (j) of section 505 of the federal Food, Drug, and Cosmetic Act 4
or the licensing of a biological product under section 351 of the federal 5
Public Health Service Act, and (2) "wholesale acquisition cost" means 6
the manufacturer's list price for a brand-name drug or a generic drug 7
per person, per year or course of treatment, when sold to wholesalers 8
or direct purchasers in the United States, not including discounts or 9
rebates, for the most recent month for which information is available. 10
(b) A manufacturer or wholesaler registered under chapter 417 of 11
the general statutes shall make a drug distributed in this state available 12
for sale in this state to an eligible product developer for purposes of 13
conducting testing required to support an application for approval of a 14
drug under subsections (b) and (j) of section 505 of the federal Food, 15 Committee Bill No. 48
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Drug, and Cosmetic Act, or the licensing of a biological product under 16
section 351 of the federal Public Health Service Act. Such manufacturer 17
or wholesaler shall make the drug available for sale at a price not 18
greater than the wholesale acquisition cost of the drug and without 19
any restriction that would block or delay the eligible product 20
developer's application in a manner inconsistent with subdivision (8) 21
of subsection (f) of section 505 of the federal Food, Drug, and Cosmetic 22
Act. 23
(c) An eligible product developer that receives a drug at a price not 24
greater than the wholesale acquisition cost for such drug pursuant to 25
this section shall charge consumers in this state the same price or less 26
for the drug manufactured by such eligible product developer. 27
(d) A manufacturer or wholesaler registered under chapter 417 of 28
the general statutes shall not be liable for injuries alleged to have been 29
caused by the failure to include adequate safety warnings on a 30
product's label or by a defect in the product's design if (1) such 31
manufacturer or wholesaler has made the product distributed in this 32
state available to an eligible product developer in accordance with the 33
provisions of this section, and (2) the product was not manufactured or 34
sold by such manufacturer or wholesaler. 35
(e) A violation of any of the provisions of subsection (b) or (c) of this 36
section shall be deemed an unfair or deceptive trade practice under 37
subsection (a) of section 42-110b of the general statutes. 38
This act shall take effect as follows and shall amend the following
sections:
Section 1 October 1, 2019 New section
GL Joint Favorable
JUD Joint Favorable