To insert provisions relating to antibiotic access and innovation and certain enantiomer drugs.

1. Adds Subtitle __--Antibiotic Access and Innovation SEC. 2__. INCENTIVES FOR THE DEVELOPMENT OF, AND ACCESS TO, CERTAIN ANTIBIOTICS at the end of title II

   Adds a section

   In S. 1082 · Reported to Senate

   The Secretary shall require that State-legalized medical marijuana be subject to the full regulatory requirements of the Food and Drug Administration, including a risk evaluation and mitigation strategy and all other requirements and penalties of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) regarding safe and effective reviews, approval, sale, marketing, and use of pharmaceuticals.

   Inserted: Subtitle __--Antibiotic Access and Innovation SEC. 2__. INCENTIVES FOR THE DEVELOPMENT OF, AND ACCESS TO, CERTAIN ANTIBIOTICS.

   Inserted: (a) In General.--Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by this Act, is further amended by adding at the end the following:

   Inserted: "(s) Antibiotic Drugs Submitted Before November 21, 1997.--

   Inserted: "(1) Antibiotic drugs approved before november 21, 1997.--

   Inserted: "(A) In general.--Notwithstanding any provision of the Food and Drug Administration Modernization Act of 1997 or any other provision of law, a sponsor of a drug that is the subject of an application described in subparagraph (B)(i) shall be eligible for, with respect to the drug, the 3-year exclusivity period referred to under clauses (iii) and (iv) of subsection (c)(3)(E) and under clauses (iii) and (iv) of subsection (j)(5)(F), subject to the requirements of such clauses, as applicable.

   Inserted: "(B) Application; antibiotic drug described.--

   Inserted: "(i) Application.--An application described in this clause is an application for marketing submitted under this section after the date of enactment of this subsection in which the drug that is the subject of the application contains an antibiotic drug described in clause (ii).

   Inserted: "(ii) Antibiotic drug.--An antibiotic drug described in this clause is an antibiotic drug that was the subject of an application approved by the Secretary under section 507 of this Act (as in effect before November 21, 1997).

   Inserted: "(2) Antibiotic drugs submitted before november 21, 1997, but not approved.--

   Inserted: "(A) In general.--Notwithstanding any provision of the Food and Drug Administration Modernization Act of 1997 or any other provision of law, a sponsor of a drug that is the subject of an application described in subparagraph (B)(i) may elect to be eligible for, with respect to the drug--

   Inserted: "(i)(I) the 3-year exclusivity period referred to under clauses (iii) and (iv) of subsection (c)(3)(E) and under clauses (iii) and (iv) of subsection (j)(5)(F), subject to the requirements of such clauses, as applicable; and

   Inserted: "(II) the 5-year exclusivity period referred to under clause (ii) of subsection (c)(3)(E) and under clause (ii) of subsection (j)(5)(F), subject to the requirements of such clauses, as applicable; or

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   Inserted: "(ii) a patent term extension under section 156 of title 35, United States Code, subject to the requirements of such section.

   Inserted: "(B) Application; antibiotic drug described.--

   Inserted: "(i) Application.--An application described in this clause is an application for marketing submitted under this section after the date of enactment of this subsection in which the drug that is the subject of the application contains an antibiotic drug described in clause (ii).

   Inserted: "(ii) Antibiotic drug.--An antibiotic drug described in this clause is an antibiotic drug that was the subject of 1 or more applications received by the Secretary under section 507 of this Act (as in effect before November 21, 1997), none of which was approved by the Secretary under such section.

   Inserted: "(3) Limitations.--

   Inserted: "(A) Exclusivities and extensions.--Paragraphs (1)(A) and (2)(A) shall not be construed to entitle a drug that is the subject of an approved application described in subparagraphs (1)(B)(i) or (2)(B)(i), as applicable, to any market exclusivities or patent extensions other than those exclusivities or extensions described in paragraph (1)(A) or (2)(A).

   Inserted: "(B) Conditions of use.--Paragraphs (1)(A) and (2)(A)(i) shall not apply to any condition of use for which the drug referred to in subparagraph (1)(B)(i) or (2)(B)(i), as applicable, was approved before the date of enactment of this subsection.

   Inserted: "(4) Application of certain provisions.--Notwithstanding section 125, or any other provision, of the Food and Drug Administration Modernization Act of 1997, or any other provision of law, and subject to the limitations in paragraphs (1), (2), and (3), the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 shall apply to any drug subject to paragraph (1) or any drug with respect to which an election is made under paragraph (2)(A).".

   Inserted: (b) Transition Rule.--With respect to a patent issued on or before the date of enactment of this Act, any patent information required to be filed with the Secretary under subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) to be listed on a drug to which subsection (s)(1) of such section 505 (as added by this section) applies shall be filed with such Secretary not later than 60 days after the date of enactment of this Act.

   Inserted: SEC. 2__. ANTIBIOTICS AS ORPHAN PRODUCTS.

   Inserted: (a) Public Meeting.--The Commissioner of Food and Drugs shall convene a public meeting and, if appropriate, issue guidance, regarding which serious and life-threatening infectious diseases, such as diseases due to gram-negative bacteria and other diseases due to antibiotic-resistant bacteria, potentially qualify for available grants and contracts under subsection (a) of section 5 of the Orphan Drug Act (21 U.S.C. 360ee(a)) or other incentives for development.

   Inserted: (b) Grants and Contracts for the Development of Orphan Drugs.--Subsection (c) of section 5 of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows:

   Inserted: "(c) For grants and contracts under subsection (a) there are authorized to be appropriated--

   Inserted: "(1) such sums as already have been appropriated for fiscal year 2007; and

   Inserted: "(2) $35,000,000 for each of fiscal years 2008 through 2012.".

   Inserted: SEC. 2__. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE CONCENTRATIONS OF ANTIMICROBIALS.

   Inserted: (a) Definition.--In this section, the term "clinically susceptible concentrations" means specific values which characterize bacteria as clinically susceptible, intermediate, or resistant to the drug (or drugs) tested.

   Inserted: (b) Identification.--The Secretary of Health and Human Services (referred to in this section as the "Secretary"), through the Commissioner of Food and Drugs, shall identify and periodically update clinically susceptible concentrations.

   Inserted: (c) Public Availability.--The Secretary, through the Commissioner of Food and Drugs, shall make such clinically susceptible concentrations publicly available within 30 days of the date of identification and any update under this section.

   Inserted: (d) Effect.--Nothing in this section shall be construed to restrict, in any manner, the prescribing of antibiotics by physicians, or to limit the practice of medicine, including for diseases such as Lyme and tick-borne diseases.

   Inserted: SEC. 2__. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.

   Inserted: Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S. C. 355), as amended by this subtitle, is amended by adding at the end the following:

   Inserted: "(t) Certain Drugs Containing Single Enantiomers.--

   Inserted: "(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 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--

   Inserted: "(A)(i) the single enantiomer has not been previously approved except in the approved racemic drug; and

   Inserted: "(ii) the application submitted under subsection (b) for such non-racemic drug--

   Inserted: "(I) includes full reports of new clinical investigations (other than bioavailability studies)--

   Inserted: "(aa) necessary for the approval of the application under subsections (c) and (d); and

   Inserted: "(bb) conducted or sponsored by the applicant; and

   Inserted: "(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

   Inserted: "(B) the application submitted under subsection (b) for such non-racemic drug is not submitted for approval of a condition of use--

   Inserted: "(i) in a therapeutic category in which the approved racemic drug has been approved; or

   Inserted: "(ii) for which any other enantiomer of the racemic drug has been approved.

   Inserted: "(2) Limitation.--

   Inserted: "(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.

   Inserted: "(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.

   Inserted: "(3) Definition.--

   Inserted: "(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 enactment of this subsection.

   Inserted: "(B) Publication by secretary.--The Secretary shall publish the list described in subparagraph (A) and may amend such list by regulation.

   Inserted: "(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 enactment of this subsection and before October 1, 2012.".

   Inserted: SEC. 2__. REPORT.

   Inserted: Not later than January 1, 2012, the Comptroller General of the United States shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that examines whether and how this subtitle has--

   Inserted: (1) encouraged the development of new antibiotics and other drugs; and

   Inserted: (2) prevented or delayed timely generic drug entry into the market.

   Original wording

   At the end of title II, insert the following:

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As printed