[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6112 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 6112
To establish postmarket reporting requirements for pharmaceuticals, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 26, 2023
Mr. Waltz 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 establish postmarket reporting requirements for pharmaceuticals, 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 ``Further Strengthening America's
Supply Chain and National Security Act''.
SEC. 2. MODIFICATION OF RULES OF ORIGIN FOR PHARMACEUTICAL PRODUCTS.
(a) Trade Agreements.--Section 308(4)(B) of the Trade Agreements
Act of 1979 (19 U.S.C. 2518(4)(B)) is amended--
(1) in clause (i), by striking ``instrumentality, or'' and
inserting ``instrumentality,'';
(2) in clause (ii), by inserting ``, other than an active
pharmaceutical ingredient,'' after ``part of materials''; and
(3) by striking the period at the end and inserting ``, or
(iii) in the case of an article which consists of an active
pharmaceutical ingredient, the pharmaceutical ingredient is
wholly the growth, product, or manufacture of that country or
instrumentality.''.
(b) Federal Acquisition Regulation.--Not later than 180 days after
the date of the enactment of this Act, the President shall prescribe
regulations to update sections 52.225-5 and 25.003 of title 48, Code of
Federal Regulations (or successor regulations) to be consistent with
rules of origin determinations for active pharmaceutical ingredients
made under section 308(4)(B) of the Trade Agreements Act of 1979 (19
U.S.C. 2518(4)(B)), as amended by subsection (a).
SEC. 3. POSTMARKET REPORTING REQUIREMENTS FOR PHARMACEUTICALS.
(a) In General.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall ensure that each
holder of an approved application under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or under section 351 of
the Public Health Service Act (42 U.S.C. 262) annually submit, as part
of the postmarket annual report required by the Secretary under section
314.81(b)(2) of title 21, Code of Federal Regulations (or any successor
regulation), the following information:
(1) The names and addresses of the sources of active and
inactive ingredients of the drug.
(2) For each active and inactive ingredient of the drug,
the percentage of the aggregate amount of such ingredient used
in the manufacture of the drug during the reporting period that
is from each of the sources identified under paragraph (1).
(b) Disclosure of Information.--The Secretary of Health and Human
Services shall--
(1) annually provide the information reported in paragraphs
(1) and (2) of subsection (a) to the Secretary of Defense for
purposes of understanding the dependency on foreign
manufacturers of drugs used by members of the Armed Forces; and
(2) publish the information reported under such paragraphs
on a publicly available internet website of the Federal
Government in a single, aggregate form, without disclosing
proprietary information.
SEC. 4. ADDITIONAL RISK FACTORS FOR CONSIDERATION DURING INSPECTIONS OF
DRUG AND DEVICE ESTABLISHMENTS.
Section 510(h)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(h)(4)) is amended--
(1) by redesignating subparagraph (G) as subparagraph (J);
and
(2) by inserting after subparagraph (F) the following:
``(G) Whether the establishment has been inspected
by an entity that carries out inspections on behalf of
a foreign government determined to be a foreign
adversary under section 7.4 of title 15, Code of
Federal Regulations (or successor regulations).
``(H) The particular drugs or devices (with a focus
on drugs and devices included on the list of essential
medicines pursuant to section 3(c) of Executive Order
13944 (85 Fed. Reg. 49929)) manufactured, prepared,
propagated, compounded, or processed in the
establishment, with particular attention to the number
of other establishments globally that also manufacture,
prepare, propagate, compound, or process the same drug
or device from which the United States sources such
drug or device.
``(I) Whether the establishment is located in a
country with a history or 1 or more previous instances
of exporting illicit drugs or precursor chemicals to
the United States, as determined by the Secretary by
reference to the most recent report submitted to
Congress pursuant to section 489 of the Foreign
Assistance Act of 1961.''.
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