REFERRAL TO ADVISORY COMMITTEE.

SEC. 918. REFERRAL TO ADVISORY COMMITTEE. Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended by section 915, is further amended by adding at the end the following:“(s) Referral to Advisory Committee.—Prior to the approval of a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 351 of the Public Health Service Act, the Secretary shall—“(1) refer such drug to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee; or“(2) if the Secretary does not refer such a drug to a Food and Drug Administration advisory committee prior to the approval of the drug, provide in the action letter on the application for the drug a summary of the reasons why the Secretary 121 STAT. 961 did not refer the drug to an advisory committee prior to approval.”.