; or (3) is a product that would benefit from early scientific engagement due to complexity or uncertainty concerning the approval pathway under section 505(j). . 202. Increasing pharmaceutical options to treat an unmet medical need Subsection (b) of section 506 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 ) is amended by adding at the end the following: (4) Unmet medical need For purposes of paragraph (1), a drug shall be deemed to address an unmet medical need for a disease or condition if fewer than 3 available drugs exist for the treatment of such disease or condition. . 203. Preemption of State barriers to the substitution of biosimilar products No State, or any political subdivision thereof, may prohibit a pharmacy or pharmacist from dispensing, in place of a biological reference product, any product that, pursuant to section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ), has been determined by the Secretary of Health and Human Services to be interchangeable with the reference product in accordance with subsections (a) and (k)(4) of such Act ( 42 U.S.C. 262(a) , (k)(4)). 204. Expedited process for biological products authorized for marketing in European Union Section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) is amended by adding at the end the following new paragraph: (4) Products authorized for marketing in European Union In considering whether to license a biological product under this subsection or subsection (k), the Secretary may expedite the licensing process if the biological product has been authorized for marketing by the European Medicines Agency and such authorization remains in effect. . III PRESCRIPTION DRUG PRICING AND COMPETITION 301. Medicare drug coverage Notwithstanding any other provision of law, the Secretary of Health and Human Services may alter payments for prescription drugs, including biologicals, provided through the Medicare part B program by paying at rates that, based on the average sales price plus 6 percent in the year of