EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.

SEC. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS. Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 920, is further amended by adding at the end the following:“(u) Certain Drugs Containing Single Enantiomers.—“(1) In general.—For purposes of subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted under subsection (b) for a non-racemic drug containing as an active ingredient (including any ester or salt of the active ingredient) a single enantiomer that is contained in a racemic drug approved in another application under subsection (b), the applicant may, in the application for such non-racemic drug, elect to have the single enantiomer not be considered the same active ingredient as that contained in the approved racemic drug, if—“(A)(i) the single enantiomer has not been previously approved except in the approved racemic drug; and“(ii) the application submitted under subsection (b) for such non-racemic drug—“(I) includes full reports of new clinical investigations (other than bioavailability studies)—“(aa) necessary for the approval of the application under subsections (c) and (d); and“(bb) conducted or sponsored by the applicant; and“(II) does not rely on any investigations that are part of an application submitted under subsection (b) for approval of the approved racemic drug; and“(B) the application submitted under subsection (b) for such non-racemic drug is not submitted for approval of a condition of use—121 STAT. 977“(i) in a therapeutic category in which the approved racemic drug has been approved; or“(ii) for which any other enantiomer of the racemic drug has been approved.“(2) Limitation.—“(A) No approval in certain therapeutic categories.—Until the date that is 10 years after the date of approval of a non-racemic drug described in paragraph (1) and with respect to which the applicant has made the election provided for by such paragraph, the Secretary shall not approve such non-racemic drug for any condition of use in the therapeutic category in which the racemic drug has been approved.“(B) Labeling.—If applicable, the labeling of a non-racemic drug described in paragraph (1) and with respect to which the applicant has made the election provided for by such paragraph shall include a statement that the non-racemic drug is not approved, and has not been shown to be safe and effective, for any condition of use of the racemic drug.“(3) Definition.—“(A) In general.—For purposes of this subsection, the term ‘therapeutic category’ means a therapeutic category identified in the list developed by the United States Pharmacopeia pursuant to section 1860D–4(b)(3)(C)(ii) of the Social Security Act and as in effect on the date of the enactment of this subsection.“(B) Publication by secretary.—The Secretary shall publish the list described in subparagraph (A) and may amend such list by regulation.“(4) Availability.—The election referred to in paragraph (1) may be made only in an application that is submitted to the Secretary after the date of the enactment of this subsection and before October 1, 2012.”.