Sec. 3. FDA authority to mandate postapproval studies or postmarket surveillance due to insufficient demographic subgroup data
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Section 505(o)(3)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3)(B) ) is amended by adding at the end the following: To provide safety and effectiveness data for the drug involved for a demographic subgroup or subgroups, if— the clinical trials conducted in support of the approval of the drug did not meet the applicable targets of enrollment, as described in section 2 of the DEPICT Act; and in the judgment of the Secretary, additional data could inform drug labeling. .
Section 505(o)(3)(D) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3)(D) ) is amended by adding at the end the following: The Secretary may not require postapproval studies or postapproval clinical trials for the purpose specified under subparagraph (B)(iv) if the sponsor provides to the Secretary a sufficient justification for not meeting the enrollment targets referred to in such subparagraph, which may include— factors outside of the sponsor’s control, such as a lack of retention of participants; differences in the enrollment targets, disaggregated by demographic subgroup, and actual enrollment that are determined by the Secretary to be insignificant in nature; information not available to the sponsor at the time such enrollment targets were chosen, but that impacted enrollment of diverse participants; potential for selection bias; and any other reason that the Secretary determines is sufficient justification. .
Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3) ) is amended by adding at the end the following: Real world evidence (as defined in section 505F(b)) may be used to support or satisfy the requirements under this paragraph. . Section 522(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360l(a)(1)(A) ) is amended— in subparagraph (A)— in clause (ii), by striking or at the end; in clause (iii)(II), by striking facility. and inserting facility; or ; and by adding at the end the following: with respect to which— clinical studies submitted to support that approval or clearance did not meet the applicable targets of enrollment, as described in section 2 of the DEPICT Act; and with respect to which a justification described in subparagraph
(D)is not provided. ; and by adding at the end the following: Real world evidence (as defined in section 505F(b)) may be used to support or satisfy the requirements under this paragraph. The Secretary may not require a manufacturer to conduct postmarket surveillance under subparagraph
(A)with respect to a device for the purpose specified in clause
(iv)of such subparagraph if the manufacturer provides to the Secretary a sufficient justification for not meeting the enrollment targets referred to in such subparagraph, which may include— factors outside of the manufacturer’s control, such as a lack of retention of participants; differences in the enrollment targets, disaggregated by demographic subgroup, and actual enrollment that are determined by the Secretary to be insignificant in nature; information not available to the manufacturer at the time such enrollment targets were chosen, but that impacted enrollment of diverse participants; potential for selection bias; and any other reason that the Secretary determines is sufficient justification. . The Commissioner of Food and Drugs shall issue regulations revising section 814.84 of title 21, Code of Federal Regulations, to require holders of an application approved under section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e ) to include in the reports submitted under such section 814.84, to the extent possible, any data not previously submitted under such section 814.84 that may inform the safety and effectiveness of the device involved in underrepresented demographic subgroups. Section 402(j)(1)(A) of the Public Health Service Act (282(j)(1)(A)) is amended— in clause (ii)— in subclause (I), by striking and at the end; in subclause (II), by striking the period at the end and inserting ; and ; and by adding at the end the following: postmarket surveillance for any device as required under clause
(iv)of section 522(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act. ; and in clause (iii)(I), by striking the period at the end and inserting the following: , including any postapproval study or postapproval clinical trial for a drug as required under section 505(o)(3)(B)(iv) of the Federal Food, Drug, and Cosmetic Act. . Not later than 270 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, and in consultation with drug sponsors, medical device manufacturers, patients, and other stakeholders, shall convene a public meeting to consider the ways by which— drug sponsors and medical device manufacturers may disseminate information to the public on clinical trial enrollment demographic data in a timely and accessible manner; drug and device sponsors, in consultation with the Commissioner of Food and Drugs, may publicly disseminate information on subgroup analyses conducted by the sponsors in cases where— such data is not sufficient for the purpose of updating drug and device labels; or such analyses do not show significant differences between demographic subgroups; and drug and device sponsors, in consultation with the Commissioner of Food and Drugs, may collect and publicly disseminate real world evidence that may provide information on the safety and effectiveness of drugs or devices for a demographic subgroup or subgroups. Not later than 180 days after the date on which the public meeting is convened under paragraph (1), the Secretary shall make available on the website of the Food and Drug Administration a report on the topics discussed at such meeting. The report shall include a summary of, and response to, recommendations raised in such meeting.
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Sec. 3
FDA authority to mandate postapproval studies or postmarket surveillance due to insufficient demographic subgroup data
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