S.Amdt. 5138

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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