AB68,1500,8 affordability review board

AB68,2915 Section 2915. 601.78 of the statutes is created to read:

AB68,1500,10 601.78 Definitions. In this subchapter:

AB68,1500,12 (1) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 21 CFR 601.20.

AB68,1500,14 (2) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 USC 262 (k) (3).

AB68,1500,16 (3) “Board” means the prescription drug affordability review board established under s. 15.735 (1).

AB68,1500,19 (4) “Brand name drug” means a drug that is produced or distributed in accordance with an original new drug application approved under 21 USC 355 (c), other than an authorized generic drug, as defined in 42 CFR 447.502.

AB68,1500,21 (5) “Drug product” means a brand name drug, a generic drug, a biologic, a biosimilar, or an over-the-counter drug.

AB68,1500,25 (6) “Financial benefit” includes an honoraria, fee, stock, the value of the stock holdings of a member of the board or any immediate family member, as defined in s. 97.605 (4) (a) 2., and any direct financial benefit deriving from the finding of a review conducted under s. 601.79.

AB68,1501,1 (7) “Generic drug” means any of the following:

AB68,1501,3 (a) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application approved under 21 USC 355 (j).

AB68,1501,4 (b) An authorized generic drug, as defined in 42 CFR 447.502.

AB68,1501,6 (c) A drug that entered the market prior to 1962 and was not originally marketed under a new drug application.

AB68,1501,7 (8) “Manufacturer” means an entity that does all of the following:

AB68,1501,10 (a) Engages in the manufacture of a drug product or enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity's own name.

AB68,1501,12 (b) Sets or changes the wholesale acquisition cost of the drug product or prescription drug product described in par. (a).

AB68,1501,14 (9) “Over-the-counter drug” means a drug intended for human use that does not require a prescription and meets the requirements of 21CFR parts 328 to 364.

AB68,1501,15 (10) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB68,1501,17 (11) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.

AB68,2916 Section 2916. 601.785 of the statutes is created to read:

AB68,1501,23 601.785 Prescription drug affordability review board. (1) Mission. The purpose of the board is to protect state residents, the state, local governments, health plans, healthcare providers, pharmacies licensed in this state, and other stakeholders of the healthcare system in this state from the high costs of prescription drug products.

AB68,1501,24 (2) Powers and duties. (a) The board shall do all of the following:

AB68,1502,3 1. Meet in open session at least 4 times per year to review prescription drug product pricing information, except that the chair may cancel or postpone a meeting if there is no business to transact.

AB68,1502,5 2. To the extent practicable, access and assess pricing information for prescription drug products by doing all of the following:

AB68,1502,8 a. Accessing and assessing information from other states by entering into memoranda of understanding with other states to which manufacturers report pricing information.

AB68,1502,9 b. Assessing spending for specific prescription drug products in this state.

AB68,1502,10 c. Accessing other available pricing information.

AB68,1502,11 (b) The board may:

AB68,1502,12 1. Promulgate rules for the administration of this subchapter.