Sec. 3. Essential pediatric cancer drug list
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The Secretary, in consultation with the Commissioner of Food and Drugs and the Director of the National Cancer Institute, shall— not later than 150 days after the date of enactment of this Act, develop a list of chemotherapeutic drugs that are essential for treating pediatric cancer; and update such list on a schedule determined by the Secretary. Under subsection (a), a chemotherapeutic drug shall be considered essential for treating pediatric cancer only if the drug— is approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) for use in the treatment of cancer; has the potential alone or in combination with other drugs to treat a pediatric cancer; is supported by 1 or more citations to treat a pediatric cancer included or approved for inclusion in— the National Comprehensive Cancer Network Compendia;
American Hospital Formulary Service Drug Information; the DRUGDEX Information System; or the PDQ Cancer Information Summaries for Health Professionals of the National Cancer Institute; and meets price, quality, manufacturing concentration, manufacturing complexity, and other appropriate metrics as determined by the Secretary.
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