Public meeting and report on mutual recognition agreements

(a) Public meeting Not later than 180 days after the date of enactment of this Act, the Secretary shall conduct a public meeting on the use of mutual recognition agreements for purposes of carrying out inspections under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) of establishments engaged in the manufacture, preparation, propagation, or processing of a biosimilar biological product, including a discussion of— (1) how mutual recognition agreements are utilized with respect to the inspection of biosimilar biological product establishments, and areas for improvements in such inspections conducted pursuant to such agreements; and (2) areas in which use of mutual recognition agreements could be expanded to apply beyond compliance inspections under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), including for use in conjunction with remote regulatory assessments, inspections conducted by trusted foreign partners identified by the Food and Drug Administration, and virtual interactions with subject matter experts. (b) Report Not later than 180 days after the public meeting under subsection (a) is conducted, the Secretary shall issue to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make publicly available, a report that includes recommendations on the use of mutual recognition agreements for purposes of conducting inspections of biosimilar biological product establishments.