{"identifier":"/us/usc/t21/s356h","title":21,"num":"\u00a7\u202f356h.","heading":"Competitive generic therapies","text":"\u00a7\u202f356h.\nCompetitive generic therapies\n(a)\nIn general\nThe Secretary may, at the request of an applicant of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of an abbreviated new drug application under\nsection 355(j) of this title\n(b)\nDesignation process\n(1)\nRequest\nThe applicant may request the Secretary to designate the drug as a competitive generic therapy.\n(2)\nTiming\nA request under paragraph (1) may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under\nsection 355(j) of this title\n(3)\nCriteria\nA drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition.\n(4)\nDesignation\nNot later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may\u2014\n(A) determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and\n(B) if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy.\n(c)\nActions\nIn expediting the development and review of an application under subsection (a), the Secretary may, as requested by the applicant, take actions including the following:\n(1) Hold meetings with the applicant and the review team throughout the development of the drug prior to submission of the application for such drug under\nsection 355(j) of this title\n(2) Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable.\n(3) Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to drug-device combination products and other complex products.\n(4) Assign a cross-disciplinary project lead\u2014\n(A) to facilitate an efficient review of the development program and application, including manufacturing inspections; and\n(B) to serve as a scientific liaison between the review team and the applicant.\n(d)\nReporting requirement\nNot later than one year after the date of the approval of an application under\nsection 355(j) of this title\n(e)\nDefinitions\nIn this section:\n(1) The term \u201cgeneric drug\u201d means a drug that is approved pursuant to\nsection 355(j) of this title\n(2) The term \u201cinadequate generic competition\u201d means, with respect to a drug, there is not more than one approved drugs\n(A) the reference listed drug; or\n(B) a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.\n(3) The term \u201creference listed drug\u201d means the listed drug (as such term is used in\nsection 355(j) of this title","url":"https://projectusc.org/usc/t21/s356h.html","content":[{"t":"sec","id":"/us/usc/t21/s356h","children":[{"t":"num","text":"\u00a7\u202f356h."},{"t":"heading","text":"Competitive generic therapies"},{"t":"subsec","id":"/us/usc/t21/s356h/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"In general"},{"t":"content","children":[{"t":"p","text":"The Secretary may, at the request of an applicant of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of an abbreviated new drug application under ","children":[{"t":"ref","text":"section 355(j) of this title","href":"/us/usc/t21/s355/j","tail":" for such drug."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s356h/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Designation process"},{"t":"para","id":"/us/usc/t21/s356h/b/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"Request"},{"t":"content","children":[{"t":"p","text":"The applicant may request the Secretary to designate the drug as a competitive generic therapy.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s356h/b/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Timing"},{"t":"content","children":[{"t":"p","text":"A request under paragraph (1) may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under ","children":[{"t":"ref","text":"section 355(j) of this title","href":"/us/usc/t21/s355/j","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s356h/b/3","children":[{"t":"num","text":"(3)"},{"t":"heading","text":"Criteria"},{"t":"content","children":[{"t":"p","text":"A drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s356h/b/4","children":[{"t":"num","text":"(4)"},{"t":"heading","text":"Designation"},{"t":"chapeau","text":"Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may\u2014"},{"t":"subpara","id":"/us/usc/t21/s356h/b/4/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s356h/b/4/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s356h/c","children":[{"t":"num","text":"(c)"},{"t":"heading","text":"Actions"},{"t":"chapeau","text":"In expediting the development and review of an application under subsection (a), the Secretary may, as requested by the applicant, take actions including the following:"},{"t":"para","id":"/us/usc/t21/s356h/c/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" Hold meetings with the applicant and the review team throughout the development of the drug prior to submission of the application for such drug under ","children":[{"t":"ref","text":"section 355(j) of this title","href":"/us/usc/t21/s355/j","tail":"."}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s356h/c/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable.","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s356h/c/3","children":[{"t":"num","text":"(3)"},{"t":"content","text":" Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to drug-device combination products and other complex products.","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s356h/c/4","children":[{"t":"num","text":"(4)"},{"t":"chapeau","text":" Assign a cross-disciplinary project lead\u2014"},{"t":"subpara","id":"/us/usc/t21/s356h/c/4/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" to facilitate an efficient review of the development program and application, including manufacturing inspections; and","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s356h/c/4/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" to serve as a scientific liaison between the review team and the applicant.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s356h/d","children":[{"t":"num","text":"(d)"},{"t":"heading","text":"Reporting requirement"},{"t":"content","children":[{"t":"p","text":"Not later than one year after the date of the approval of an application under ","children":[{"t":"ref","text":"section 355(j) of this title","href":"/us/usc/t21/s355/j","tail":" with respect to a drug for which the development and review is expedited under this section, the sponsor of such drug shall report to the Secretary on whether the drug has been marketed in interstate commerce since the date of such approval."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s356h/e","children":[{"t":"num","text":"(e)"},{"t":"heading","text":"Definitions"},{"t":"chapeau","text":"In this section:"},{"t":"para","id":"/us/usc/t21/s356h/e/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" The term \u201cgeneric drug\u201d means a drug that is approved pursuant to ","children":[{"t":"ref","text":"section 355(j) of this title","href":"/us/usc/t21/s355/j","tail":"."}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s356h/e/2","children":[{"t":"num","text":"(2)"},{"t":"chapeau","text":" The term \u201cinadequate generic competition\u201d means, with respect to a drug, there is not more than one approved drugs\u202f","children":[{"t":"ref","text":"1"},{"t":"num","text":"1","tail":"\u202fSo in original. Probably should be \u201cdrug\u201d."},{"t":"text","text":"\u202fSo in original. Probably should be \u201cdrug\u201d.","tail":" on the list of drugs described in "},{"t":"ref","text":"section 355(j)(7)(A) of this title","href":"/us/usc/t21/s355/j/7/A","tail":" (not including drugs on the discontinued section of such list) that is\u2014"}]},{"t":"subpara","id":"/us/usc/t21/s356h/e/2/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" the reference listed drug; or","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s356h/e/2/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s356h/e/3","children":[{"t":"num","text":"(3)"},{"t":"content","text":" The term \u201creference listed drug\u201d means the listed drug (as such term is used in ","children":[{"t":"ref","text":"section 355(j) of this title","href":"/us/usc/t21/s355/j","tail":") for the drug involved."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}