AB50,1406,19 601.78 Definitions. In this subchapter:

AB50,1406,21 (1) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 21 CFR 601.20.

AB50,1406,23 (2) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 USC 262 (k) (3).

AB50,1407,2 (3) “Board” means the prescription drug affordability review board established under s. 15.735 (1).

AB50,1407,5 (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.

AB50,1407,9 (5) “Financial benefit” includes an honorarium, fee, stock, the value of the stock holdings of a member of the board or any immediate family member of the member of the board, and any direct financial benefit deriving from the finding of a review conducted under s. 601.79.

AB50,1407,10 (6) “Generic drug” means any of the following:

AB50,1407,12 (a) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application approved under 21 USC 355 (j).

AB50,1407,13 (b) An authorized generic drug, as defined in 42 CFR 447.502.

AB50,1407,15 (c) A drug that entered the market prior to 1962 and was not originally marketed under a new drug application.

AB50,1407,18 (7) “Immediate family member” means a spouse, grandparent, parent, sibling, child, stepchild, or grandchild or the spouse of a grandparent, parent, sibling, child, stepchild, or grandchild.

AB50,1407,19 (8) “Manufacturer” means an entity that does all of the following:

AB50,1407,22 (a) Engages in the manufacture of a prescription drug product or enters into a lease with another entity to market and distribute a prescription drug product under the entity’s own name.

AB50,1408,2 (b) Sets or changes the wholesale acquisition cost of the prescription drug product described in par. (a).

AB50,1408,3 (9) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB50,1408,5 (10) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.

AB50,2892 Section 2892. 601.785 of the statutes is created to read:

AB50,1408,11 601.785 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.

AB50,1408,12 (2) Powers and duties. (a) The board shall do all of the following:

AB50,1408,15 1. Meet in open session at least 4 times per year to review prescription drug product pricing information in the manner described in subd. 2., except that the chairperson may cancel or postpone a meeting if there is no business to transact.

AB50,1408,17 2. To the extent practicable, access and assess pricing information for prescription drug products by doing all of the following:

AB50,1408,20 a. Accessing and assessing information from other states by entering into memoranda of understanding with other states to which manufacturers report pricing information.

AB50,1408,21 b. Assessing spending for specific prescription drug products in this state.

AB50,1408,22 c. Accessing other available pricing information.

AB50,1408,23 (b) The board may do any of the following:

AB50,1409,1 1. Promulgate rules for the administration of this subchapter.

AB50,1409,6 2. Enter into a contract with an independent 3rd party for any service necessary to carry out the powers and duties of the board. Unless written permission is granted by the board, any person with whom the board contracts may not release, publish, or otherwise use any information to which the person has access under the contract.

AB50,1409,9 (c) The board shall establish and maintain a website to provide public notices and make meeting materials available under sub. (3) (a) and to disclose conflicts of interest under sub. (4) (d).

AB50,1409,13 (3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide public notice of each board meeting at least 2 weeks prior to the meeting and shall make the materials for each meeting publicly available at least one week prior to the meeting.