Safe and Secure Medicine Supply for Hardworking Americans Act of 2020
This bill bans in certain instances the importation of drugs and medical devices from a foreign manufacturing facility that has been subject to a recall, imposes additional duties on imported drugs, and contains other related provisions.
The Food and Drug Administration shall ban drug or device imports from a foreign facility for a specified amount of time if a drug or device from that facility has been subject to a Class I or Class II recall. The bill imposes civil monetary fines for any individual or entity that violates such an import ban.
The bill also imposes, on top of any other duties, a 25% duty on drugs imported from China, a 20% duty on drugs imported from India, and a 10% duty on drugs imported from any other country.
The duties and fines established under this bill shall go into a fund for supporting and incentivizing new pharmaceutical or medical device manufacturing in the United States.
The bill also requires each drug sold to state on its label the country of origin of each active pharmaceutical ingredient.
[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>
Introduced in House
Introduced in House
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.
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.
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