| 4 | 4 | | SB.docx |
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| 5 | 5 | | 1 of 2 |
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| 6 | 6 | | |
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| 7 | 7 | | General Assembly Substitute Bill No. 262 |
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| 8 | 8 | | January Session, 2021 |
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| 9 | 9 | | |
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| 10 | 10 | | |
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| 11 | 11 | | |
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| 12 | 12 | | AN ACT REQUIRING MAN UFACTURERS OF BRAND NAME |
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| 13 | 13 | | PRESCRIPTION DRUGS T O PROVIDE SAMPLES OF SUCH DRUGS |
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| 14 | 14 | | TO MANUFACTURERS OF GENERIC PRESCRIPTION DRUGS. |
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| 15 | 15 | | Be it enacted by the Senate and House of Representatives in General |
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| 16 | 16 | | Assembly convened: |
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| 17 | 17 | | |
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| 18 | 18 | | Section 1. (NEW) (Effective October 1, 2021) (a) As used in this section: 1 |
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| 19 | 19 | | (1) "Eligible product developer" means a person who seeks to develop 2 |
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| 20 | 20 | | an application for the approval of a drug under subsections (b) and (j) 3 |
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| 21 | 21 | | of Section 505 of the federal Food, Drug and Cosmetic Act or the 4 |
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| 22 | 22 | | licensing of a biological product under Section 351 of the federal Public 5 |
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| 23 | 23 | | Health Service Act, and (2) "wholesale acquisition cost" means the 6 |
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| 24 | 24 | | manufacturer's list price for a brand-name drug or a generic drug per 7 |
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| 25 | 25 | | person, year or course of treatment, when sold to wholesalers or direct 8 |
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| 26 | 26 | | purchasers in the United States, not including discounts or rebates, for 9 |
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| 27 | 27 | | the most recent month for which information is available. 10 |
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| 28 | 28 | | (b) A manufacturer or wholesaler registered under chapter 417 of the 11 |
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| 29 | 29 | | general statutes shall make a drug manufactured or developed by such 12 |
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| 30 | 30 | | manufacturer or wholesaler and distributed in this state available for 13 |
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| 31 | 31 | | sale in this state to an eligible product developer for purposes of 14 |
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| 32 | 32 | | conducting testing required to support an application by such eligible 15 |
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| 33 | 33 | | product developer for approval of a drug under subsections (b) and (j) 16 |
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| 34 | 34 | | of Section 505 of the federal Food, Drug and Cosmetic Act, or the 17 |
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| 35 | 35 | | licensing of a biological product under Section 351 of the federal Public 18 |
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| 36 | 36 | | Health Service Act. Such manufacturer or wholesaler shall make the 19 Substitute Bill No. 262 |
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| 37 | 37 | | |
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| 38 | 38 | | |
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| 39 | 39 | | LCO {\\PRDFS1\SCOUSERS\FORZANOF\WS\2021SB-00262- |
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| 41 | 41 | | 2 of 2 |
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| 42 | 42 | | |
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| 43 | 43 | | drug available for sale to such eligible product developer at a price not 20 |
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| 44 | 44 | | greater than the wholesale acquisition cost of the drug and without any 21 |
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| 45 | 45 | | restriction that would block or delay the eligible product developer's 22 |
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| 46 | 46 | | application in a manner inconsistent with Section 505-1(f)(8) of the 23 |
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| 47 | 47 | | federal Food, Drug and Cosmetic Act. 24 |
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| 48 | 48 | | (c) An eligible product developer that receives a drug at a price not 25 |
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| 49 | 49 | | greater than the wholesale acquisition cost for such drug pursuant to 26 |
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| 50 | 50 | | this section shall charge consumers in this state the same price or less 27 |
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| 51 | 51 | | for the drug manufactured by such eligible product developer. 28 |
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| 52 | 52 | | (d) A manufacturer or wholesaler registered under chapter 417 of the 29 |
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| 53 | 53 | | general statutes shall not be liable for injuries alleged to have been 30 |
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| 54 | 54 | | caused by the failure of the eligible product developer to include 31 |
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| 55 | 55 | | adequate safety warnings on a product's label or by a defect in the 32 |
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| 56 | 56 | | product's design if (1) such manufacturer or wholesaler has made the 33 |
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| 57 | 57 | | product distributed in this state available to an eligible product 34 |
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| 58 | 58 | | developer in accordance with the provisions of this section, and (2) the 35 |
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| 59 | 59 | | product was not manufactured or sold by such manufacturer or 36 |
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| 60 | 60 | | wholesaler. 37 |
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| 61 | 61 | | (e) A violation of any of the provisions of subsection (b) or (c) of this 38 |
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| 62 | 62 | | section shall be deemed an unfair or deceptive trade practice under 39 |
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| 63 | 63 | | subsection (a) of section 42-110b of the general statutes. 40 |
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| 64 | 64 | | This act shall take effect as follows and shall amend the following |
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| 65 | 65 | | sections: |
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| 66 | 66 | | |
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| 67 | 67 | | Section 1 October 1, 2021 New section |
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| 68 | 68 | | |
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| 69 | 69 | | |
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| 70 | 70 | | GL Joint Favorable Subst. -LCO |
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| 71 | 71 | | JUD Joint Favorable |
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