Sec. 1132. ASSESSMENT AND MODIFICATION OF REMS
1,148 words·~5 min read·
/statute-compilations/comps-9932/sec-1132A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 1132 ASSESSMENT AND MODIFICATION OF REMS ###
(a)Assessment and Modification of Approved Strategy Section 505-1(g) (21 U.S.C. 355-1(g)) is amended— ####
(1)in paragraph (1), by striking “, and propose a modification to,”; ####
(2)in paragraph (2)— #####
(A)in the matter before subparagraph (A)— ######
(i)by striking “, subject to paragraph (5),”; and ######
(ii)by striking “, and may propose a modification to,”; #####
(B)in subparagraph (C), by striking “ new safety or effectiveness information indicates that ” and all that follows and inserting the following: > “an assessment is needed to evaluate whether the approved strategy should be modified to— > > > ###### “(i) > > ensure the benefits of the drug outweigh the risks of the drug; or > > > ###### “(ii) > > minimize the burden on the health care delivery system of complying with the strategy.” > ; and #####
(C)by striking subparagraph (D); ####
(3)in paragraph (3), by striking “for a drug shall include—” and all that follows and inserting the following “for a drug shall include, with respect to each goal included in the strategy, an assessment of the extent to which the approved strategy, including each element of the strategy, is meeting the goal or whether 1 or more such goals or such elements should be modified.”; and ####
(4)by amending paragraph
(4)to read as follows: > > #### “(4) Modification > > > ##### “(A) On initiative of responsible person > > After the approval of a risk evaluation and mitigation strategy by the Secretary, the responsible person may, at any time, submit to the Secretary a proposal to modify the approved strategy. Such proposal may propose the addition, modification, or removal of any goal or element of the approved strategy and shall include an adequate rationale to support such proposed addition, modification, or removal of any goal or element of the strategy. > > > ##### “(B) On initiative of secretary > > After the approval of a risk evaluation and mitigation strategy by the Secretary, the Secretary may, at any time, require a responsible person to submit a proposed modification to the strategy within 120 days or within such reasonable time as the Secretary specifies, if the Secretary, in consultation with the offices described in subsection (c)(2), determines that 1 or more goals or elements should be added, modified, or removed from the approved strategy to— > > > ###### “(i) > > ensure the benefits of the drug outweigh the risks of the drug; or > > > ###### “(ii) > > minimize the burden on the health care delivery system of complying with the strategy.” > . ###
(b)Review of Proposed Strategies; Review of Assessments and Modifications of Approved Strategies Section 505-1(h) (21 U.S.C. 355-1(h)) is amended— ####
(1)in the subsection heading by inserting “and Modifications” after “Review of Assessments”; ####
(2)in paragraph (1)— #####
(A)by inserting “and proposed modification to” after “under subsection
(a)and each assessment of”; and #####
(B)by inserting “, and, if necessary, promptly initiate discussions with the responsible person about such proposed strategy, assessment, or modification” after “subsection (g)”; ####
(3)by striking paragraph (2); ####
(4)by redesignating paragraphs
(3)through
(9)as paragraphs
(2)through (8), respectively; ####
(5)in paragraph (2), as redesignated by paragraph (4)— #####
(A)by amending subparagraph
(A)to read as follows: > > ##### “(A) In general > > > ###### “(i) Timeframe > > Unless the dispute resolution process described under paragraph
(3)or
(4)applies, and, except as provided in clause
(ii)or clause
(iii)below, the Secretary, in consultation with the offices described in subsection (c)(2), shall review and act on the proposed risk evaluation and mitigation strategy for a drug or any proposed modification to any required strategy within 180 days of receipt of the proposed strategy or modification. > > > ###### “(ii) Minor modifications > > The Secretary shall review and act on a proposed minor modification, as defined by the Secretary in guidance, within 60 days of receipt of such modification. > > > ###### “(iii) REMS modification due to safety label changes > > Not later than 60 days after the Secretary receives a proposed modification to an approved risk evaluation and mitigation strategy to conform the strategy to approved safety label changes, including safety labeling changes initiated by the sponsor in accordance with FDA regulatory requirements, or to a safety label change that the Secretary has directed the holder of the application to make pursuant to section 505(o)(4), the Secretary shall review and act on such proposed modification to the approved strategy. > > > ###### “(iv) Guidance > > The Secretary shall establish, through guidance, that responsible persons may implement certain modifications to an approved risk evaluation and mitigation strategy following notification to the Secretary.” > ; and #####
(B)by amending subparagraph
(C)to read as follows: > > ##### “(C) Public availability > > Upon acting on a proposed risk evaluation and mitigation strategy or proposed modification to a risk evaluation and mitigation strategy under subparagraph (A), the Secretary shall make publicly available an action letter describing the actions taken by the Secretary under such subparagraph (A).” > ; ####
(6)in paragraph (4), as redesignated by paragraph (4)— #####
(A)in subparagraph (A)(i)— ######
(i)by striking “Not earlier than 15 days, and not later than 35 days, after discussions under paragraph
(2)have begun, the” and inserting “The”; and ######
(ii)by inserting “, after the sponsor is required to make a submission under subsection (a)(2) or (g),” before “request in writing”; and #####
(B)in subparagraph (I)— ######
(i)by striking clauses
(i)and (ii); and ######
(ii)by striking “if the Secretary—” and inserting “if the Secretary has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board, providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G), respectively.”; ####
(7)in paragraph (5), as redesignated by paragraph (4)— #####
(A)in subparagraph (A), by striking “any of subparagraphs
(B)through (D)” and inserting “subparagraph
(B)or (C)”; and #####
(B)in subparagraph (C), by striking “paragraph
(4)or (5)” and inserting “paragraph
(3)or (4)”; and ####
(8)in paragraph (8), as redesignated by paragraph (4), by striking “paragraphs
(7)and (8)” and inserting “paragraphs
(6)and (7).”. ###
(c)Guidance **[**[21 U.S.C. 355-1 note](/us/usc/t21/s355-1)**]** Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that, for purposes of section 505-1(h)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(h)(2)(A)), describes the types of modifications to approved risk evaluation and mitigation strategies that shall be considered to be minor modifications of such strategies.
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 1132
ASSESSMENT AND MODIFICATION OF REMS
Cites 1Cited by 0 across 0 sources