[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6885 Introduced in House (IH)]

<DOC>






116th CONGRESS
  2d Session
                                H. R. 6885

   To amend the Federal Food, Drug, and Cosmetic Act to prohibit the 
   importation of a drug or device that was manufactured at a banned 
  foreign facility, to create incentives for pharmaceutical or device 
companies to increase manufacturing capacity in the United States, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 15, 2020

  Mr. Flores introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   Ways and Means, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to prohibit the 
   importation of a drug or device that was manufactured at a banned 
  foreign facility, to create incentives for pharmaceutical or device 
companies to increase manufacturing capacity in the United States, 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 ``Safe and Secure Medicine Supply for 
Hardworking Americans Act of 2020''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Safe drug and device importation.
Sec. 4. Imposition of additional duties on drugs from China, India, and 
                            other countries.
Sec. 5. Secure Medicines Supply Fund.
Sec. 6. Registry of drugs manufactured outside the United States.
Sec. 7. Country-of-origin labeling.

SEC. 3. SAFE DRUG AND DEVICE IMPORTATION.

    (a) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(fff) The importation of a drug or device that was manufactured 
or processed at a banned foreign facility for which an order is in 
effect under section 810.''.
    (b) Issuance of Order.--The Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 809 of such Act (21 U.S.C. 384e) the 
following new section:

``SEC. 810. BANNED FOREIGN FACILITIES.

    ``(a) Determination.--The Secretary shall issue an order 
determining a facility to be a banned foreign facility if--
            ``(1) the facility manufactures or processes any drug or 
        device that is imported into the United States; and
            ``(2) a Class I or Class II recall is issued by the Food 
        and Drug Administration for any drug or device that is 
        manufactured or processed at such facility.
    ``(b) Duration.--
            ``(1) Banned facilities with class i recall.--For a banned 
        facility for which a Class I recall is issued as described in 
        subsection (a)(2):
                    ``(A) The designation of the banned facility 
                pursuant to an order under subsection (a), based on an 
                initial Class I recall of a drug or device manufactured 
                or processed at the facility, shall be in effect for 
                the 10-year period beginning on the date that is one 
                year after the issuance of the order.
                    ``(B) The designation of the banned facility 
                pursuant to an order under subsection (a), based on a 
                subsequent Class I recall of a drug or device 
                manufactured or processed at the facility, shall be in 
                effect permanently beginning on the date that is one 
                year after the issuance of such order.
            ``(2) Banned facilities with class ii recall.--For a banned 
        facility for which a class II recall is issued as described in 
        subsection (a)(2):
                    ``(A) The designation of the banned facility 
                pursuant to an order under subsection (a), based on an 
                initial Class II recall of a drug or device 
                manufactured or processed at the facility, shall be in 
                effect for the 5-year period beginning on the date that 
                is one year after the issuance of the order.
                    ``(B) The designation of the banned facility 
                pursuant to an order under subsection (a), based on a 
                first subsequent Class II recall of a drug or device 
                manufactured or processed at the facility, may be 
                renewed to be in effect for a period of 5 years 
                beginning--
                            ``(i) if the initial 5-year period under 
                        subparagraph (A) has concluded, one year from 
                        the date of the first subsequent recall; or
                            ``(ii) if the initial 5-year period under 
                        subparagraph (A) has not concluded, at the 
                        conclusion of such initial 5-year period.
                    ``(C) The designation of the banned facility 
                pursuant to an order under subsection (a), based on a 
                second subsequent Class II recall of a drug or device 
                manufactured or processed at the facility, shall be in 
                effect permanently beginning--
                            ``(i) if the first subsequent 5-year period 
                        under subparagraph (B) has concluded, one year 
                        after the issuance of the order; or
                            ``(ii) if the first subsequent 5-year 
                        period under subparagraph (B) has not 
                        concluded, immediately.
    ``(c) Definition.--In this section:
            ``(1) The term `banned facility' means a banned foreign 
        facility for which an order is in effect under subsection (a).
            ``(2) The terms `Class I' and `Class II', in connection 
        with a recall, mean classified as Class I or Class II, 
        respectively, by the Food and Drug Administration pursuant to 
        section 7.41 of title 21, Code of Federal Regulations (or any 
        successor regulations).''.
    (c) Applicability.--Section 810 of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (b), applies only with respect to 
recalls issued or reissued on or after the date of enactment of this 
Act.
    (d) Civil Monetary Penalties.--Subsection (f) of section 303 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 
adding at the end the following new paragraph:
    ``(10) Any person who violates section 301(fff) shall be subject to 
a civil money penalty not to exceed--
            ``(A) if the violation involves a Class I recall, as 
        described in section 810(a)(2)--
                    ``(i) $25,000,000 if the violation is the first 
                violation of section 301(fff) by such person; and
                    ``(ii) $100,000,000 if the violation is a 
                subsequent violation of section 301(fff) by such 
                person; and
            ``(B) if the violation involves a Class II recall, as 
        described in section 810(a)(2)--
                    ``(i) $10,000,000 if the violation is the first 
                violation of section 301(fff) by such person; and
                    ``(ii) $50,000,000 if the violation is a subsequent 
                violation of section 301(fff) by such person.''.

SEC. 4. IMPOSITION OF ADDITIONAL DUTIES ON DRUGS FROM CHINA, INDIA, AND 
              OTHER COUNTRIES.

    (a) Drugs From China.--
            (1) In general.--In addition to any other duty, there is 
        imposed a duty on drugs which are being imported or offered for 
        import into the United States (within the meaning of section 
        801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        381(a))) from the People's Republic of China.
            (2) Rate of duty.--The rate of duty imposed by paragraph 
        (1) shall be 25 percent ad valorem.
    (b) Drugs From India.--
            (1) In general.--In addition to any other duty, there is 
        imposed a duty on drugs which are being imported or offered for 
        import into the United States (within the meaning of section 
        801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        381(a))) from the Republic of India.
            (2) Rate of duty.--The rate of duty imposed by paragraph 
        (1) shall be 20 percent ad valorem.
    (c) Drugs From Other Countries.--
            (1) In general.--In addition to any other duty, there is 
        imposed a duty on drugs which are being imported or offered for 
        import into the United States (within the meaning of section 
        801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        381(a))) from any foreign country other than the People's 
        Republic of China or the Republic of India.
            (2) Rate of duty.--
                    (A) In general.--Except as provided in subparagraph 
                (B), the rate of duty imposed by paragraph (1) shall be 
                10 percent ad valorem.
                    (B) Exception.--In the case of a drug that includes 
                one or more active pharmaceutical ingredients 
                originating from the People's Republic of China or the 
                Republic of India, the rate of duty imposed by 
                paragraph (1) shall be--
                            (i) 25 percent ad valorem for those 
                        containing an active pharmaceutical ingredient 
                        from China; and
                            (ii) 20 percent ad valorem for those 
                        containing an active pharmaceutical ingredient 
                        from India.
    (d) Effective Date.--The provisions of this section shall apply to 
articles described in subsections (a), (b), and (c) entered, or 
withdrawn from warehouse for consumption, on or after the date that is 
15 days after the date of the enactment of this Act.

SEC. 5. SECURE MEDICINES SUPPLY FUND.

    (a) Establishment.--There is established in the Treasury of the 
United States a fund, to be known as the Secure Medicines Supply Fund 
(in this section referred to as the ``Fund''), consisting of such 
amounts as may be deposited to the Fund pursuant to subsection (b) to 
be used, in accordance with subsection (c), for the purpose of 
supporting and incentivizing pharmaceutical or device companies to 
invest in new pharmaceutical or device manufacturing capacity in the 50 
States, the District of Columbia, Puerto Rico, the Virgin Islands, 
Guam, American Samoa, and the Commonwealth of the Northern Mariana 
Islands.
    (b) Requirements.--To be eligible for investment under subsection 
(a), new pharmaceutical or device manufacturing capacity shall meet 
each of the following:
            (1) The products supported by the new pharmaceutical or 
        device manufacturing capacity do not use active pharmaceutical 
        ingredients or parts manufactured in China or India.
            (2) At least 50 percent of the active pharmaceutical 
        ingredients or parts for the total product line of the 
        respective company is manufactured in any of the 50 States, the 
        District of Columbia, Puerto Rico, the Virgin Islands, Guam, 
        American Samoa, or the Commonwealth of the Northern Mariana 
        Islands.
    (c) Funding.--
            (1) Duties.--Amounts collected from duties imposed pursuant 
        to section 4 shall be deposited in the Fund, to remain 
        available until expended.
            (2) Fines.--Amounts collected from civil monetary penalties 
        imposed pursuant to paragraph (10) of section 303(f) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)), as 
        added by section 3(d), shall be deposited in the Fund, to 
        remain available until expended.
    (d) Distribution of Funds.--
            (1) Grants.--The Secretary of Health and Human Services 
        shall establish a grant program to support and incentivize 
        pharmaceutical or device companies to manufacture prescription 
        drugs, active pharmaceutical ingredients, or devices in any of 
        the 50 States, the District of Columbia, Puerto Rico, the 
        Virgin Islands, Guam, American Samoa, and the Commonwealth of 
        the Northern Mariana Islands.
            (2) Limitations on use of funds.--As a condition on receipt 
        of a grant under this section, the recipient of the grant shall 
        agree to use--
                    (A) not more than 10 percent of the grant for new 
                or expanded manufacturing capacity;
                    (B) not more than 50 percent of the grant for 
                training manufacturing workers; and
                    (C) not more than 25 percent of the grant for 
                developing one or more new prescription drugs, new 
                active pharmaceutical ingredients, or new antibiotics.
            (3) Source of funding.--All amounts used to carry out this 
        section shall be derived from the Fund.
    (e) Report.--Not later than one year after the date of enactment of 
this Act, and annually thereafter, the Secretary of Health and Human 
Services shall submit to the Congress a report on the Fund. Each such 
report shall address the following:
            (1) The amounts deposited into the Fund in the most recent 
        three fiscal years.
            (2) The distribution of such amounts pursuant to grants 
        under this section during the last three fiscal years, 
        including the allocation of such amounts for--
                    (A) new or expanded manufacturing capacity;
                    (B) training workers; and
                    (C) developing new prescription drugs, new active 
                pharmaceutical ingredients, or new antibiotics.
    (f) Device.--In this section, the term ``device'' has the meaning 
given to such term in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321).
    (g) Sunset.--This section (other than subsection (e)) shall cease 
to have effect beginning on the date that is 10 years after the date of 
the enactment of this Act.
    (h) Unused Funds Returned to the General Fund of the Treasury.--If 
any amounts remain in the Fund after the date described in subsection 
(f), the Secretary of the Treasury shall transfer such amounts to the 
general fund of the Treasury.

SEC. 6. REGISTRY OF DRUGS MANUFACTURED OUTSIDE THE UNITED STATES.

    The Federal Food, Drug, and Cosmetic Act is amended by inserting 
after section 524A of such Act (21 U.S.C. 360n-1) the following new 
section:

``SEC. 524B. REGISTRY OF DRUGS MANUFACTURED OUTSIDE THE UNITED STATES.

    ``(a) In General.--The Secretary shall compile and maintain a 
registry of all drugs approved under subsection (c) or (j) of section 
505 of this Act or licensed under sub-section (a) or (k) of section 351 
of the Public Health Service Act, and any active pharmaceutical 
ingredients in such drugs, that are manufactured outside of the United 
States. The Secretary shall update such registry at least biannually.
    ``(b) Additional List.--
            ``(1) In general.--In conjunction with the registry under 
        subsection (a), the Secretary shall compile and maintain a list 
        of those drugs included in the registry for which 50 percent or 
        more of their active pharmaceutical ingredients are 
        manufactured in locations within a single country outside the 
        United States.
            ``(2) Contents.--The list of drugs under paragraph (1) 
        shall--
                    ``(A) identify both the drugs and the associated 
                sole-source country;
                    ``(B) be updated at least bi-annually; and
                    ``(C) be publicly available.
    ``(c) Requirement.--The registry under subsection (a) shall, with 
respect to each drug included on the registry, 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.''.

SEC. 7. COUNTRY-OF-ORIGIN LABELING.

    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 pharmaceutical ingredient contained in 
the drug.''.
                                 <all>