AB544,3,8 (a) The commissioner of insurance or his or her designee.

AB544,3,12 (b) Two members appointed for 4-year terms who represent the pharmaceutical drug industry, including pharmaceutical drug manufacturers and wholesalers. At least one of the members appointed under this paragraph shall be a licensed pharmacist.

AB544,3,14 (c) Two members appointed for 4-year terms who represent the health insurance industry, including insurers and pharmacy benefit managers.

AB544,3,17 (d) Two members appointed for 4-year terms who represent the health care industry, including hospitals, physicians, pharmacies, and pharmacists. At least one of the members appointed under this paragraph shall be a licensed practitioner.

AB544,3,19 (e) Two members appointed for 4-year terms who represent the interests of the public.

AB544,4,3 (2) A member appointed under sub. (1) may not be an employee of, a board member of, or a consultant to a drug manufacturer or trade association for drug manufacturers.

AB544,4,8 (3) Any conflict of interest, including any financial or personal association, that has the potential to bias or has the appearance of biasing an individual's decision in matters related to the board or the conduct of the board's activities shall be considered and disclosed when appointing that individual to the board under sub. (1).

AB544,3 Section 3 . Subchapter VI (title) of chapter 601 [precedes 601.78] of the statutes is created to read:

AB544,4,11 CHAPTER 601

AB544,4,13 SUBCHAPTER VI Prescription drug

AB544,4,14 affordability review board

AB544,4,15 601.78 Definitions. In this subchapter:

AB544,4,17 (1) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 21 CFR 601.20.

AB544,4,19 (2) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 USC 262 (k) (3).

AB544,4,21 (3) “Board” means the prescription drug affordability review board established under s. 15.735 (1).

AB544,4,24 (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.

AB544,5,2 (5) “Drug product” means a brand name drug, a generic drug, a biologic, a biosimilar, or an over-the-counter drug.

AB544,5,6 (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.

AB544,5,7 (7) “Generic drug” means any of the following:

AB544,5,9 (a) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application approved under 21 USC 355 (j).

AB544,5,10 (b) An authorized generic drug, as defined in 42 CFR 447.502.

AB544,5,12 (c) A drug that entered the market prior to 1962 and was not originally marketed under a new drug application.

AB544,5,13 (8) “Manufacturer” means an entity that does all of the following:

AB544,5,16 (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.

AB544,5,18 (b) Sets or changes the wholesale acquisition cost of the drug product or prescription drug product described in par. (a).

AB544,5,20 (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.

AB544,5,21 (10) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB544,5,23 (11) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.

AB544,6,3 601.785 Prescription drug affordability review board. (1) Mission. The purpose of the board is to protect state residents, the state, local governments, health plans, health care providers, pharmacies licensed in this state, and other stakeholders of the health care system in this state from the high costs of prescription drug products.