ENHANCING ACCESS TO AFFORDABLE MEDICINES.

SEC. 3224. ENHANCING ACCESS TO AFFORDABLE MEDICINES. Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) through (iii) and inserting the following:“(i) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of when the application is otherwise eligible for approval under this subsection; “(ii) the sponsor of the application agrees to submit revised labeling for the drug that is the subject of the application not later than 60 days after approval under this subsection of the application; “(iii) the labeling revision described under clause (i) does not include a change to the ‘Warnings’ section of the labeling; and” .