Page 30

136 STAT. 1846 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(i) A vaccine that is licensed under section 351 of the Public Health Service Act and marketed pursu- ant to such section. ‘‘(ii) A selected drug for which a manufacturer had an agreement under this part with the Secretary with respect to an initial price applicability year that is before 2030. ‘‘(C) CLARIFICATION.—Nothing in subparagraph (B)(ii) shall limit the transition of a selected drug described in paragraph (3)(A) to a long-monopoly drug if the selected drug meets the definition of a long-monopoly drug. ‘‘(5) LONG-MONOPOLY DRUG DEFINED.— ‘‘(A) IN GENERAL.—In this part, subject to subpara- graph (B), the term ‘long-monopoly drug’ means, with respect to an initial price applicability year, a selected drug for which at least 16 years have elapsed since the date of approval of such drug under section 505(c) of the Federal Food, Drug, and Cosmetic Act or since the date of licensure of such drug under section 351(a) of the Public Health Service Act, as applicable. ‘‘(B) EXCLUSION.—The term ‘long-monopoly drug’ shall not include a vaccine that is licensed under section 351 of the Public Health Service Act and marketed pursuant to such section. ‘‘(6) AVERAGE NON-FEDERAL AVERAGE MANUFACTURER PRICE.—In this part, the term ‘average non-Federal average manufacturer price’ means the average of the non-Federal aver- age manufacturer price (as defined in section 8126(h)(5) of title 38, United States Code) for the 4 calendar quarters of the year involved. ‘‘(d) TEMPORARY FLOOR FOR SMALL BIOTECH DRUGS.—In the case of a selected drug that is a qualifying single source drug described in section 1192(d)(2) and with respect to which the first initial price applicability year of the price applicability period with respect to such drug is 2029 or 2030, the maximum fair price negotiated under this section for such drug for such initial price applicability year may not be less than 66 percent of the average non-Federal average manufacturer price for such drug (as defined in subsection (c)(6)) for 2021 (or, in the case that there is not an average non-Federal average manufacturer price available for such drug for 2021, for the first full year following the market entry for such drug), increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) from September 2021 (or December of such first full year following the market entry), as applicable, to Sep- tember of the year prior to the selected drug publication date with respect to the initial price applicability year. ‘‘(e) FACTORS.—For purposes of negotiating the maximum fair price of a selected drug under this part with the manufacturer of the drug, the Secretary shall consider the following factors, as applicable to the drug, as the basis for determining the offers and counteroffers under subsection (b) for the drug: ‘‘(1) MANUFACTURER-SPECIFIC DATA.—The following data, with respect to such selected drug, as submitted by the manu- facturer: Time periods. Time period. Time period. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00030 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw