{"identifier":"/us/usc/t21/s355g","title":21,"num":"\u00a7\u202f355g.","heading":"Utilizing real world evidence","text":"\u00a7\u202f355g.\nUtilizing real world evidence\n(a)\nIn general\nThe Secretary shall establish a program to evaluate the potential use of real world evidence\u2014\n(1) to help to support the approval of a new indication for a drug approved under\nsection 355(c) of this title\n(2) to help to support or satisfy postapproval study requirements.\n(b)\nReal world evidence defined\nIn this section, the term \u201creal world evidence\u201d means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.\n(c)\nProgram framework\n(1)\nIn general\nNot later than 2 years after\nDecember 13, 2016\n(2)\nContents of framework\nThe framework shall include information describing\u2014\n(A) the sources of real world evidence, including ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research activities;\n(B) the gaps in data collection activities;\n(C) the standards and methodologies for collection and analysis of real world evidence; and\n(D) the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address.\n(3)\nConsultation\n(A)\nIn general\nIn developing the program framework under this subsection, the Secretary shall consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, consumer organizations, disease research foundations, and other interested parties.\n(B)\nProcess\nThe consultation under subparagraph (A) may be carried out through approaches such as\u2014\n(i) a public-private partnership with the entities described in such subparagraph in which the Secretary may participate;\n(ii) a contract, grant, or other arrangement, as the Secretary determines appropriate, with such a partnership or an independent research organization; or\n(iii) public workshops with the entities described in such subparagraph.\n(d)\nProgram implementation\nThe Secretary shall, not later than 3 years after\nDecember 13, 2016\n(e)\nGuidance for industry\nThe Secretary shall\u2014\n(1) utilize the program established under subsection (a), its activities, and any subsequent pilots or written reports, to inform a guidance for industry on\u2014\n(A) the circumstances under which sponsors of drugs and the Secretary may rely on real world evidence for the purposes described in paragraphs (1) and (2) of subsection (a); and\n(B) the appropriate standards and methodologies for collection and analysis of real world evidence submitted for such purposes;\n(2) not later than 5 years after\nDecember 13, 2016\n(3) not later than 18 months after the close of the public comment period for the draft guidance described in paragraph (2), issue revised draft guidance or final guidance.\n(f)\nRule of construction\n(1)\nIn general\nSubject to paragraph (2), nothing in this section prohibits the Secretary from using real world evidence for purposes not specified in this section, provided the Secretary determines that sufficient basis exists for any such nonspecified use.\n(2)\nStandards of evidence and Secretary\u2019s authority\nThis section shall not be construed to alter\u2014\n(A) the standards of evidence under\u2014\n(i) subsection (c) or (d) of\nsection 355 of this title\n(ii) section 262(a) of title 42\n(B) the Secretary\u2019s authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated.","url":"https://projectusc.org/usc/t21/s355g.html","content":[{"t":"sec","id":"/us/usc/t21/s355g","children":[{"t":"num","text":"\u00a7\u202f355g."},{"t":"heading","text":"Utilizing real world evidence"},{"t":"subsec","id":"/us/usc/t21/s355g/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"In general"},{"t":"chapeau","text":"The Secretary shall establish a program to evaluate the potential use of real world evidence\u2014"},{"t":"para","id":"/us/usc/t21/s355g/a/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" to help to support the approval of a new indication for a drug approved under ","children":[{"t":"ref","text":"section 355(c) of this title","href":"/us/usc/t21/s355/c","tail":"; and"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s355g/a/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" to help to support or satisfy postapproval study requirements.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s355g/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Real world evidence defined"},{"t":"content","children":[{"t":"p","text":"In this section, the term \u201creal world evidence\u201d means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s355g/c","children":[{"t":"num","text":"(c)"},{"t":"heading","text":"Program framework"},{"t":"para","id":"/us/usc/t21/s355g/c/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"In general"},{"t":"content","children":[{"t":"p","text":"Not later than 2 years after ","children":[{"t":"text","text":"December 13, 2016","tail":", the Secretary shall establish a draft framework for implementation of the program under this section."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s355g/c/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Contents of framework"},{"t":"chapeau","text":"The framework shall include information describing\u2014"},{"t":"subpara","id":"/us/usc/t21/s355g/c/2/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" the sources of real world evidence, including ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research activities;","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s355g/c/2/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" the gaps in data collection activities;","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s355g/c/2/C","children":[{"t":"num","text":"(C)"},{"t":"content","text":" the standards and methodologies for collection and analysis of real world evidence; and","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s355g/c/2/D","children":[{"t":"num","text":"(D)"},{"t":"content","text":" the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s355g/c/3","children":[{"t":"num","text":"(3)"},{"t":"heading","text":"Consultation"},{"t":"subpara","id":"/us/usc/t21/s355g/c/3/A","children":[{"t":"num","text":"(A)"},{"t":"heading","text":"In general"},{"t":"content","children":[{"t":"p","text":"In developing the program framework under this subsection, the Secretary shall consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, consumer organizations, disease research foundations, and other interested parties.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s355g/c/3/B","children":[{"t":"num","text":"(B)"},{"t":"heading","text":"Process"},{"t":"chapeau","text":"The consultation under subparagraph (A) may be carried out through approaches such as\u2014"},{"t":"clause","id":"/us/usc/t21/s355g/c/3/B/i","children":[{"t":"num","text":"(i)"},{"t":"content","text":" a public-private partnership with the entities described in such subparagraph in which the Secretary may participate;","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s355g/c/3/B/ii","children":[{"t":"num","text":"(ii)"},{"t":"content","text":" a contract, grant, or other arrangement, as the Secretary determines appropriate, with such a partnership or an independent research organization; or","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s355g/c/3/B/iii","children":[{"t":"num","text":"(iii)"},{"t":"content","text":" public workshops with the entities described in such subparagraph.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s355g/d","children":[{"t":"num","text":"(d)"},{"t":"heading","text":"Program implementation"},{"t":"content","children":[{"t":"p","text":"The Secretary shall, not later than 3 years after ","children":[{"t":"text","text":"December 13, 2016","tail":", and in accordance with the framework established under subsection (c), implement the program to evaluate the potential use of real world evidence."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s355g/e","children":[{"t":"num","text":"(e)"},{"t":"heading","text":"Guidance for industry"},{"t":"chapeau","text":"The Secretary shall\u2014"},{"t":"para","id":"/us/usc/t21/s355g/e/1","children":[{"t":"num","text":"(1)"},{"t":"chapeau","text":" utilize the program established under subsection (a), its activities, and any subsequent pilots or written reports, to inform a guidance for industry on\u2014"},{"t":"subpara","id":"/us/usc/t21/s355g/e/1/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" the circumstances under which sponsors of drugs and the Secretary may rely on real world evidence for the purposes described in paragraphs (1) and (2) of subsection (a); and","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s355g/e/1/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" the appropriate standards and methodologies for collection and analysis of real world evidence submitted for such purposes;","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s355g/e/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" not later than 5 years after ","children":[{"t":"text","text":"December 13, 2016","tail":", issue draft guidance for industry as described in paragraph (1); and"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s355g/e/3","children":[{"t":"num","text":"(3)"},{"t":"content","text":" not later than 18 months after the close of the public comment period for the draft guidance described in paragraph (2), issue revised draft guidance or final guidance.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s355g/f","children":[{"t":"num","text":"(f)"},{"t":"heading","text":"Rule of construction"},{"t":"para","id":"/us/usc/t21/s355g/f/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"In general"},{"t":"content","children":[{"t":"p","text":"Subject to paragraph (2), nothing in this section prohibits the Secretary from using real world evidence for purposes not specified in this section, provided the Secretary determines that sufficient basis exists for any such nonspecified use.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s355g/f/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Standards of evidence and Secretary\u2019s authority"},{"t":"chapeau","text":"This section shall not be construed to alter\u2014"},{"t":"subpara","id":"/us/usc/t21/s355g/f/2/A","children":[{"t":"num","text":"(A)"},{"t":"chapeau","text":" the standards of evidence under\u2014"},{"t":"clause","id":"/us/usc/t21/s355g/f/2/A/i","children":[{"t":"num","text":"(i)"},{"t":"content","text":" subsection (c) or (d) of ","children":[{"t":"ref","text":"section 355 of this title","href":"/us/usc/t21/s355","tail":", including the substantial evidence standard in such subsection (d); or"}],"tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s355g/f/2/A/ii","children":[{"t":"num","text":"(ii)"},{"t":"content","text":" ","children":[{"t":"ref","text":"section 262(a) of title 42","href":"/us/usc/t42/s262/a","tail":"; or"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s355g/f/2/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" the Secretary\u2019s authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}