| 4 | 4 | | SB.docx |
|---|
| 5 | 5 | | 1 of 2 |
|---|
| 6 | 6 | | |
|---|
| 7 | 7 | | General Assembly Committee Bill No. 48 |
|---|
| 8 | 8 | | January Session, 2019 |
|---|
| 9 | 9 | | LCO No. 6307 |
|---|
| 10 | 10 | | |
|---|
| 11 | 11 | | |
|---|
| 12 | 12 | | Referred to Committee on GENERAL LAW |
|---|
| 13 | 13 | | |
|---|
| 14 | 14 | | |
|---|
| 15 | 15 | | Introduced by: |
|---|
| 16 | 16 | | (GL) |
|---|
| 17 | 17 | | |
|---|
| 18 | 18 | | |
|---|
| 19 | 19 | | |
|---|
| 20 | 20 | | AN ACT REQUIRING MANUFA CTURERS OF BRAND NAM E |
|---|
| 21 | 21 | | PRESCRIPTION DRUGS T O PROVIDE SAMPLES OF SUCH DRUGS |
|---|
| 22 | 22 | | TO MANUFACTURERS OF GENERIC PRESCRIPTION DRUGS. |
|---|
| 23 | 23 | | Be it enacted by the Senate and House of Representatives in General |
|---|
| 24 | 24 | | Assembly convened: |
|---|
| 25 | 25 | | |
|---|
| 26 | 26 | | Section 1. (NEW) (Effective October 1, 2019) (a) As used in this 1 |
|---|
| 27 | 27 | | section: (1) "Eligible product developer" means a person who seeks to 2 |
|---|
| 28 | 28 | | develop an application for the approval of a drug under subsections 3 |
|---|
| 29 | 29 | | (b) and (j) of section 505 of the federal Food, Drug, and Cosmetic Act 4 |
|---|
| 30 | 30 | | or the licensing of a biological product under section 351 of the federal 5 |
|---|
| 31 | 31 | | Public Health Service Act, and (2) "wholesale acquisition cost" means 6 |
|---|
| 32 | 32 | | the manufacturer's list price for a brand-name drug or a generic drug 7 |
|---|
| 33 | 33 | | per person, per year or course of treatment, when sold to wholesalers 8 |
|---|
| 34 | 34 | | or direct purchasers in the United States, not including discounts or 9 |
|---|
| 35 | 35 | | rebates, for the most recent month for which information is available. 10 |
|---|
| 36 | 36 | | (b) A manufacturer or wholesaler registered under chapter 417 of 11 |
|---|
| 37 | 37 | | the general statutes shall make a drug distributed in this state available 12 |
|---|
| 38 | 38 | | for sale in this state to an eligible product developer for purposes of 13 |
|---|
| 39 | 39 | | conducting testing required to support an application for approval of a 14 |
|---|
| 40 | 40 | | drug under subsections (b) and (j) of section 505 of the federal Food, 15 Committee Bill No. 48 |
|---|
| 41 | 41 | | |
|---|
| 42 | 42 | | |
|---|
| 43 | 43 | | LCO 6307 {\\PRDFS1\SCOUSERS\FORZANOF\WS\2019SB-00048- |
|---|
| 45 | 45 | | 2 of 2 |
|---|
| 46 | 46 | | |
|---|
| 47 | 47 | | Drug, and Cosmetic Act, or the licensing of a biological product under 16 |
|---|
| 48 | 48 | | section 351 of the federal Public Health Service Act. Such manufacturer 17 |
|---|
| 49 | 49 | | or wholesaler shall make the drug available for sale at a price not 18 |
|---|
| 50 | 50 | | greater than the wholesale acquisition cost of the drug and without 19 |
|---|
| 51 | 51 | | any restriction that would block or delay the eligible product 20 |
|---|
| 52 | 52 | | developer's application in a manner inconsistent with subdivision (8) 21 |
|---|
| 53 | 53 | | of subsection (f) of section 505 of the federal Food, Drug, and Cosmetic 22 |
|---|
| 54 | 54 | | Act. 23 |
|---|
| 55 | 55 | | (c) An eligible product developer that receives a drug at a price not 24 |
|---|
| 56 | 56 | | greater than the wholesale acquisition cost for such drug pursuant to 25 |
|---|
| 57 | 57 | | this section shall charge consumers in this state the same price or less 26 |
|---|
| 58 | 58 | | for the drug manufactured by such eligible product developer. 27 |
|---|
| 59 | 59 | | (d) A manufacturer or wholesaler registered under chapter 417 of 28 |
|---|
| 60 | 60 | | the general statutes shall not be liable for injuries alleged to have been 29 |
|---|
| 61 | 61 | | caused by the failure to include adequate safety warnings on a 30 |
|---|
| 62 | 62 | | product's label or by a defect in the product's design if (1) such 31 |
|---|
| 63 | 63 | | manufacturer or wholesaler has made the product distributed in this 32 |
|---|
| 64 | 64 | | state available to an eligible product developer in accordance with the 33 |
|---|
| 65 | 65 | | provisions of this section, and (2) the product was not manufactured or 34 |
|---|
| 66 | 66 | | sold by such manufacturer or wholesaler. 35 |
|---|
| 67 | 67 | | (e) A violation of any of the provisions of subsection (b) or (c) of this 36 |
|---|
| 68 | 68 | | section shall be deemed an unfair or deceptive trade practice under 37 |
|---|
| 69 | 69 | | subsection (a) of section 42-110b of the general statutes. 38 |
|---|
| 70 | 70 | | This act shall take effect as follows and shall amend the following |
|---|
| 71 | 71 | | sections: |
|---|
| 72 | 72 | | |
|---|
| 73 | 73 | | Section 1 October 1, 2019 New section |
|---|
| 74 | 74 | | |
|---|
| 75 | 75 | | GL Joint Favorable |
|---|
| 76 | 76 | | JUD Joint Favorable |
|---|