Sec. 907. REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN CLINICAL TRIALS AND DATA ANALYSIS IN APPLICATIONS FOR DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES
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## SEC. 907 REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN CLINICAL TRIALS AND DATA ANALYSIS IN APPLICATIONS FOR DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES ###
(a)Report ####
(1)In general Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner, shall publish on the Internet Web site of the Food and Drug Administration a report, consistent with the regulations of the Food and Drug Administration pertaining to the protection of sponsors’ confidential commercial information as of the date of enactment of this Act, addressing the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups including sex, age, race, and ethnicity, is included in applications submitted to the Food and Drug Administration, and shall provide such publication to Congress. ####
(2)Contents of report The report described in paragraph
(1)shall contain the following: #####
(A)A description of existing tools to ensure that data to support demographic analyses are submitted in applications for drugs, biological products, and devices, and that these analyses are conducted by applicants consistent with applicable Food and Drug Administration requirements and Guidance for Industry. The report shall address how the Food and Drug Administration makes available information about differences in safety and effectiveness of medical products according to demographic subgroups, such as sex, age, racial, and ethnic subgroups, to health care providers, researchers, and patients. #####
(B)An analysis of the extent to which demographic data subset analyses on sex, age, race, and ethnicity is presented in new drug applications for new molecular entities under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in biologics license applications under section 351 of the Public Health Service Act (42 U.S.C. 262), and in premarket approval applications under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) for products approved or licensed by the Food and Drug Administration, consistent with applicable requirements and Guidance for Industry, and consistent with the regulations of the Food and Drug Administration pertaining to the protection of sponsors’ confidential commercial information as of the date of enactment of this Act. #####
(C)An analysis of the extent to which demographic subgroups, including sex, age, racial, and ethnic subgroups, are represented in clinical studies to support applications for approved or licensed new molecular entities, biological products, and devices. #####
(D)An analysis of the extent to which a summary of product safety and effectiveness data by demographic subgroups including sex, age, race, and ethnicity is readily available to the public in a timely manner by means of the product labeling or the Food and Drug Administration’s Internet Web site. ###
(b)Action Plan ####
(1)In general Not later than 1 year after the publication of the report described in subsection (a), the Secretary, acting through the Commissioner, shall publish an action plan on the Internet Web site of the Food and Drug Administration, and provide such publication to Congress. ####
(2)Content of action plan The plan described in paragraph
(1)shall include— #####
(A)recommendations, as appropriate, to improve the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and in labeling; #####
(B)recommendations, as appropriate, on the inclusion of such data, or the lack of availability of such data in labeling; #####
(C)recommendations, as appropriate, to otherwise improve the public availability of such data to patients, health care providers, and researchers; and #####
(D)a determination with respect to each recommendation identified in subparagraphs
(A)through
(C)that distinguishes between product types referenced in subsection (a)(2)(B) insofar as the applicability of each such recommendation to each type of product. ###
(c)Definitions In this section: ####
(1)The term “Commissioner” means the Commissioner of Food and Drugs. ####
(2)The term “device” has the meaning given such term in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)). ####
(3)The term “drug” has the meaning given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)). ####
(4)The term “biological product” has the meaning given such term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)). ####
(5)The term “Secretary” means the Secretary of Health and Human Services.
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Sec. 907
REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN CLINICAL TRIALS AND DATA ANALYSIS IN APPLICATIONS FOR DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES
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