[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3537 Introduced in Senate (IS)]
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116th CONGRESS
2d Session
S. 3537
To require the Secretary of Health and Human Services to maintain a
list of the country of origin of all drugs marketed in the United
States, to ban the use of Federal funds for the purchase of drugs
manufactured in China, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 19, 2020
Mr. Cotton (for himself, Mrs. Blackburn, and Mr. Cruz) introduced the
following bill; which was read twice and referred to the Committee on
Finance
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A BILL
To require the Secretary of Health and Human Services to maintain a
list of the country of origin of all drugs marketed in the United
States, to ban the use of Federal funds for the purchase of drugs
manufactured in China, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Protecting Our Pharmaceutical Supply
Chain from China Act of 2020''.
SEC. 2. COUNTRY OF ORIGIN OF DRUGS.
(a) In General.--Subchapter A of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at
the end the following:
``SEC. 524B. REGISTRY OF DRUGS PRODUCED OUTSIDE THE UNITED STATES.
``(a) In General.--The Secretary shall compile and maintain a list
of all drugs approved under subsection (c) or (j) of section 505 of
this Act or licensed under subsection (a) or (k) of section 351 of the
Public Health Service Act, and any active ingredients in such drugs,
that--
``(1) are manufactured outside of the United States; and
``(2) are determined by the Secretary to be critical to the
health and safety of consumers in the United States.
``(b) Additional List.--In conjunction with the list described in
subsection (a), the Secretary shall compile and maintain a list of
drugs included on such list that are exclusively produced in, or use
active or inactive ingredients produced in, the People's Republic of
China.
``(c) Requirement.--The list described in subsection (a) shall,
with respect to each drug included on the list, provide information
about the drug's supply chain, including each step in the supply chain
that occurs prior to the drug's importation into the United States.''.
(b) Federal Health Program Purchase of Drugs.--
(1) In general.--Notwithstanding any other provision of
law, the Department of Health and Human Services, the
Department of Veterans Affairs, the Department of Defense, and
any other Federal health care program (as defined in section
1128B(f) of the Social Security Act (42 U.S.C. 1320a-7b(b)),
with respect to the purchase of a drug by such agency or
program, the following shall apply:
(A) By 2022, a purchaser of drugs described in this
subsection shall only purchase drugs that contain 60
percent or more of their active pharmaceutical
ingredients manufactured in countries--
(i) other than the People's Republic of
China; and
(ii) that meet the Food and Drug
Administration's health and safety standards.
(B) By 2023, a purchaser of drugs described in this
subsection shall only purchase drugs that contain 100
percent of their active pharmaceutical ingredients
manufactured in countries--
(i) other than the People's Republic of
China; and
(ii) that meet the Food and Drug
Administration's health and safety standards.
(2) Waivers.--The Secretary of Health and Human Services
may issue waivers of the requirements under paragraph (1) for
any agency or program that is unable to meet such requirements
and demonstrates a need for the waiver. No waiver may be issued
under this paragraph for drugs that are purchased on or after
January 1, 2025.
(c) Labeling Requirement.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
``(ee) If it is a drug and its labeling does not specify the
country of origin of each active ingredient contained in the drug.''.
SEC. 3. TEMPORARY 100 PERCENT EXPENSING FOR PHARMACEUTICAL AND MEDICAL
DEVICE MANUFACTURING PROPERTY.
(a) In General.--For purposes of section 168(k) of the Internal
Revenue Code of 1986, in the case of any qualified pharmaceutical and
medical device manufacturing property which is placed in service after
December 31, 2019, and before January 1, 2026--
(1) such property shall be treated as qualified property
(within the meaning of such section),
(2) the applicable percentage otherwise determined under
section 168(k)(6) of such Code with respect to such property
shall be 100 percent, and
(3) paragraph (8) of such section shall not apply.
(b) Qualified Pharmaceutical and Medical Device Manufacturing
Property.--For purposes of this section, the term ``qualified
pharmaceutical and medical device manufacturing property'' means any
tangible property placed in service in the United States as part of the
construction or expansion of property for the manufacture of drugs (as
defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)) or medical devices (as defined in section 201(h) of
such Act (21 U.S.C. 321(h)).
(c) Termination.--This section shall not apply to any property
placed in service after December 31, 2025.
SEC. 4. RULE OF CONSTRUCTION.
Nothing in this Act shall be construed to divert the resources of
the Food and Drug Administration from responding to the COVID-19 public
health emergency.
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