Misbranded drugs and devices

If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indication approved under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 for such drug or device, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug or device under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 . The requirements set forth in section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request.

( June 25, 1938, ch. 675, § 502 , 52 Stat. 1050 ; June 23, 1939, ch. 242, § 3 , 53 Stat. 854 ; Dec. 22, 1941, ch. 613, § 2 , 55 Stat. 851 ; July 6, 1945, ch. 281, § 2 , 59 Stat. 463 ; Mar. 10, 1947, ch. 16, § 2 , 61 Stat. 11 ; July 13, 1949, ch. 305, § 1 , 63 Stat. 409 ; Aug. 5, 1953, ch. 334, § 1 , 67 Stat. 389 ; Pub. L. 86–618, title I, § 102(b)(2) , July 12, 1960 , 74 Stat. 398 ; Pub. L. 87–781, title I , §§ 105(c), 112(a), (b), 131(a), title III, § 305, Oct. 10, 1962 , 76 Stat. 785 , 790, 791, 795; Pub. L. 90–399, § 105(a) , July 13, 1968 , 82 Stat. 352 ; Pub. L. 91–601, § 6(d) , formerly § 7(d), Dec. 30, 1970 , 84 Stat. 1673 , renumbered Pub. L. 97–35, title XII, § 1205(c) , Aug. 13, 1981 , 95 Stat. 716 ; Pub. L. 94–295 , §§ 3(e), 4(b)(2), 5(a), 9(b)(2), May 28, 1976 , 90 Stat. 577 , 580, 583; Pub. L. 95–633, title I, § 111 , Nov. 10, 1978 , 92 Stat. 3773 ; Pub. L. 102–300, § 3(a)(2) , June 16, 1992 , 106 Stat. 239 ; Pub. L. 102–571, title I, § 107(9) , Oct. 29, 1992 , 106 Stat. 4499 ; Pub. L. 103–80, § 3(m) , Aug. 13, 1993 , 107 Stat. 777 ; Pub. L. 105–115, title I , §§ 114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, § 412(c), Nov. 21, 1997 , 111 Stat. 2312 , 2325, 2327, 2375; Pub. L. 107–250, title II, § 206 , title III, §§ 301(a), 302(a)(1), Oct. 26, 2002 , 116 Stat. 1613 , 1616; Pub. L. 108–214, § 2(b)(2)(B) , Apr. 1, 2004 , 118 Stat. 575 ; Pub. L. 108–282, title I, § 102(b)(5)(E) , Aug. 2, 2004 , 118 Stat. 902 ; Pub. L. 109–43, § 2(c)(1) , Aug. 1, 2005 , 119 Stat. 441 ; Pub. L. 109–462, § 2(d) , Dec. 22, 2006 , 120 Stat. 3472 ; Pub. L. 110–85, title IX , §§ 901(d)(3)(A), (6), 902(a), 906(a), Sept. 27, 2007 , 121 Stat. 940 , 942, 943, 949; Pub. L. 112–144, title III, § 306 , title VII, §§ 702(a), 714(c), July 9, 2012 , 126 Stat. 1024 , 1065, 1074; Pub. L. 112–193, § 2(a) , Oct. 5, 2012 , 126 Stat. 1443 ; Pub. L. 113–54, title I, § 103(b) , title II, § 206(b), Nov. 27, 2013 , 127 Stat. 597 , 639; Pub. L. 114–255, div. A, title III , §§ 3037, 3044(b)(2), Dec. 13, 2016 , 130 Stat. 1105 , 1121; Pub. L. 115–234, title III, § 303(a) , Aug. 14, 2018 , 132 Stat. 2436 ; Pub. L. 116–136, div. A, title III, § 3852 , Mar. 27, 2020 , 134 Stat. 454 ; Pub. L. 117–328, div. FF, title III, § 3630(a) , Dec. 29, 2022 , 136 Stat. 5893 .)