1. Short title This Act may be cited as the Medicare Negotiation and Competitive Licensing Act of 2018 . 2. Requiring the Secretary of Health and Human Services to negotiate prices of prescription drugs furnished under part D of the Medicare program Section 1860D–11 of the Social Security Act ( 42 U.S.C. 1395w–111 ) is amended by striking subsection (i) and inserting the following new subsection: (i) Negotiation of lower drug prices (1) In general Notwithstanding any other provision of law, the Secretary shall, for plan years beginning on or after the date of the enactment of this subsection, negotiate with pharmaceutical manufacturers the prices (including discounts, rebates, and other price concessions) that may be charged to PDP sponsors and MA organizations during a negotiated price period (as specified by the Secretary) for covered part D drugs for part D eligible individuals who are enrolled under a prescription drug plan or under an MA–PD plan. In negotiating such prices under this section, the Secretary shall take into account the following factors: (A) The comparative clinical effectiveness and cost effectiveness, when available from an impartial source, of such drug. (B) The budgetary impact of providing coverage of such drug. (C) The number of similarly effective drugs or alternative treatment regimens for each approved use of such drug. (D) The associated financial burden on patients that utilize such drug. (E) The associated unmet patient need for such drug. (F) The total revenues from global sales obtained by the manufacturer for such drug. (2) Finalization of negotiated price The negotiated price of each covered part D drug for a negotiated price period shall be finalized not later than 30 days before a PDP sponsor is required to submit information described in subsection (b)(2) for the first plan year in such negotiated price period. (3) Competitive licensing authority (A) In general Notwithstanding any exclusivity under clause (iii) or (iv) of section 505(j)(5)(F) of the Federal Food, Drug, and