[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3635 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  2d Session
                                S. 3635

  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, or 
reimbursement for, drugs manufactured in China, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 6, 2020

Mr. Cotton (for himself, Mrs. Blackburn, Mr. Cruz, Mr. Daines, and Mr. 
 Scott of Florida) introduced the following bill; which was read twice 
                and referred to the Committee on Finance

_______________________________________________________________________

                                 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, or 
reimbursement for, 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, or Reimbursement for, 
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, or reimbursement for, a drug 
        by such agency or program, the following shall apply:
                    (A) By 2022, a purchaser of, or reimbursor for, 
                drugs described in this subsection shall purchase drugs 
                or reimburse for drugs only if such drugs 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, or reimbursor for, 
                drugs described in this subsection shall purchase drugs 
                or reimburse for drugs only if such drugs 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.
                                 <all>