[Congressional Record (Bound Edition), Volume 162 (2016), Part 12]
[Senate]
[Page 15817]
[From the U.S. Government Publishing Office, www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 5138. Mr. SANDERS submitted an amendment intended to be proposed 
by him to the bill H.R. 34, to authorize and strengthen the tsunami 
detection, forecast, warning, research, and mitigation program of the 
National Oceanic and Atmospheric Administration, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the appropriate place in division A, insert the 
     following:

     SEC. ___. NEGOTIATION OF LOWER COVERED PART D DRUG PRICES ON 
                   BEHALF OF MEDICARE BENEFICIARIES.

       (a) Negotiation by Secretary.--Section 1860D-11 of the 
     Social Security Act (42 U.S.C. 1395w-111) is amended by 
     striking subsection (i) (relating to noninterference) and 
     inserting the following:
       ``(i) Negotiation of Lower Drug Prices.--
       ``(1) In general.--Notwithstanding any other provision of 
     law, the Secretary shall negotiate with pharmaceutical 
     manufacturers the prices (including discounts, rebates, and 
     other price concessions) that may be charged to PDP sponsors 
     and MA organizations for covered part D drugs for part D 
     eligible individuals who are enrolled under a prescription 
     drug plan or under an MA-PD plan.
       ``(2) No change in rules for formularies.--
       ``(A) In general.--Nothing in paragraph (1) shall be 
     construed to authorize the Secretary to establish or require 
     a particular formulary.
       ``(B) Construction.--Subparagraph (A) shall not be 
     construed as affecting the Secretary's authority to ensure 
     appropriate and adequate access to covered part D drugs under 
     prescription drug plans and under MA-PD plans, including 
     compliance of such plans with formulary requirements under 
     section 1860D-4(b)(3).
       ``(3) Construction.--Nothing in this subsection shall be 
     construed as preventing the sponsor of a prescription drug 
     plan, or an organization offering an MA-PD plan, from 
     obtaining a discount or reduction of the price for a covered 
     part D drug below the price negotiated under paragraph 
     (1).''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect on the date of the enactment of this Act 
     and shall first apply to negotiations and prices for plan 
     years beginning on January 1, 2017.

     SEC. __. PRESCRIPTION DRUG IMPORTATION.

       (a) Importation by Pharmacists and Wholesalers.--Section 
     804(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     384(b)) is amended by striking ``The Secretary,'' and 
     inserting ``The Secretary, not later than January 1, 2017,''.
       (b) Importation by Individuals.--
       (1) In general.--Section 804 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 384) is amended--
       (A) in subsection (f), by striking ``within Canada'';
       (B) in subsection (j)--
       (i) in paragraph (1), in the matter preceding subparagraph 
     (A), by inserting ``from countries other than Canada'' after 
     ``devices''; and
       (ii) in paragraph (3)--

       (I) in the heading, by striking ``from canada'' and 
     inserting ``from countries other than canada''; and
       (II) in subparagraph (C), by striking ``from Canada,''; and

       (C) by striking subsection (l) and inserting the following:
       ``(l) Importation of Prescription Drugs From Canada.--
     Individuals may import from Canada any prescription drug that 
     meets the requirements of subparagraphs (A) through (F) of 
     subsection (j)(3).''.
       (2) Regulations.--Not later than January 1, 2017, the 
     Secretary of Health and Human Services shall promulgate 
     regulations with respect to subsection (l) of section 804 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) (as 
     amended by paragraph (1)(B)).
       (3) Effective date.--The amendments made by paragraph (1) 
     shall take effect on the effective date of the final 
     regulations promulgated in accordance with paragraph (2).
       (c) FDASIA Amendment.--Subsection (c) of section 708 of the 
     Food and Drug Administration Safety and Innovation Act 
     (Public Law 112-144; 126 Stat. 1068) is amended by striking 
     ``The amendment made by'' and all that follows through the 
     period at the end and inserting ``The amendment made by 
     subsection (a) and the regulations promulgated under 
     subsection (b) shall apply beginning on the effective date of 
     the regulations promulgated under section 804(b) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(b)) and 
     the amendments made by section 201(b) of the 21st Century 
     Cures Act.''.

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