PUBLIC DOCKET ON PROPOSED CHANGES TO THIRD-PARTY VENDORS.

SEC. 3223. PUBLIC DOCKET ON PROPOSED CHANGES TO THIRD-PARTY VENDORS.(a) In General.—(1) Opening public docket.—Not later than 90 days after the date of enactment of this Act, the Secretary shall open a single public docket to solicit comments on factors that generally should be considered by the Secretary when reviewing requests from sponsors of drugs subject to risk evaluation and mitigation strategies to change third-party vendors engaged by sponsors to aid in implementation and management of the strategies. (2) Factors.—Such factors include the potential effects of changes in third-party vendors on—(A) patient access; and (B) prescribing and administration of the drugs by health care providers. (3) Closing public docket.—The Secretary may close such public docket not earlier than 90 days after such docket is opened. (4) No delay.—Nothing in this section shall delay agency action on any modification to a risk evaluation and mitigation strategy. (b) GAO Report.—Not later than December 31, 2026, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives 136 STAT. 5831 and the Committee on Health, Education, Labor, and Pensions of the Senate a report on—(1) the number of changes in third-party vendors (engaged by sponsors to aid implementation and management of risk evaluation and mitigation strategies) for an approved risk evaluation and mitigation strategy the Secretary has approved under section 505–1(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(h)); (2) any issues affecting patient access to the drug that is subject to the strategy or considerations with respect to the administration or prescribing of such drug by health care providers that arose as a result of such changes; and (3) how such issues were resolved, as applicable.