Patient experience data

(a) Policy Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) is amended— (1) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and (2) by inserting after subsection (a) the following: (b) Collection, submission, and use of data (1) In general The Secretary shall— (A) for any drug for which an exemption is granted for investigational use under section 505(i) of this Act or section 351(a) of the Public Health Service Act, require the sponsor of the drug to collect standardized patient experience data as part of the clinical trials conducted pursuant to such exemption; (B) require any application for the approval or licensing of such drug under section 505(b) of this Act or section 351(a) of the Public Health Service Act to include— (i) the standardized patient experience data so collected; and (ii) such related information as the Secretary may require; and (C) consider patient experience data and related information that is submitted pursuant to subparagraph (B) in deciding whether to approve or license, as applicable, the drug involved. (2) Applicability Paragraph (1) applies only with respect to drugs for which a request for an exemption described in paragraph (1)(A) is submitted on or after the date of the enactment of the Health Equity and Accountability Act of 2026, or an application under section 505(b) of this Act or section 351(a) of the Public Health Service Act is filed, as applicable, on or after the day that is 2 years after the date of the enactment of the Health Equity and Accountability Act of 2026.. (b) Regulations Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate final regulations to implement section 569C(b) of the Federal Food, Drug, and Cosmetic Act, as added by this section.