[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6049 Introduced in House (IH)]
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116th CONGRESS
2d Session
H. R. 6049
To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced
security for the medical supply chain.
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IN THE HOUSE OF REPRESENTATIVES
March 2, 2020
Mr. Gallagher (for himself and Mr. Pocan) introduced the following
bill; which was referred to the Committee on Energy and Commerce
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A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced
security for the medical supply chain.
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 ``Medical Supply Chain Security Act''.
SEC. 2. MEDICAL SUPPLY CHAIN SECURITY.
(a) Additional Manufacturer Reporting for Essential Medical
Devices.--Section 506C of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356c) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by
inserting ``or device'' after ``a drug''; and
(B) in the flush matter by inserting ``or device''
after ``drug'' each place such term appears;
(2) in subsection (c), by inserting ``and devices'' after
``drugs'';
(3) in subsection (g)--
(A) in the matter preceding paragraph (1), by
striking ``drug shortage of a drug'' and inserting
``shortage of a drug or device'';
(B) in paragraph (1), by striking ``; or'' and
inserting a semicolon;
(C) by redesignating paragraph (2) as paragraph
(3);
(D) by inserting after paragraph (1) the following:
``(2) expedite the review of a device subject to premarket
approval under section 515 that could help mitigate or prevent
such shortage; or''; and
(E) in paragraph (3), as so redesignated, by
striking ``drug shortage'' and inserting ``shortage'';
(4) in subsection (h)--
(A) by amending paragraph (2) to read as follows:
``(2) the term `shortage', with respect to a drug or
device, means a period of time when the demand or projected
demand for the drug or device within the United States exceeds
the supply of the drug or device; and''; and
(B) in paragraph (3)(A), by inserting ``or device''
after ``drug''; and
(5) by adding at the end the following:
``(j) Additional Manufacturer Reporting for Essential Drugs and
Devices.--Each manufacturer of a drug or device described in subsection
(a) shall provide to the Food and Drug Administration, on an annual
basis, or more frequently at the request of the Secretary, information
related to the manufacturing capacity of such drug or device. Such
information shall include--
``(1) details about--
``(A) all locations of production;
``(B) the sourcing of all component parts;
``(C) the sourcing of any active pharmaceutical
ingredients; and
``(D) the use of any scarce raw materials; and
``(2) any other information determined by the Secretary to
be relevant to the security of the supply chain of the drug or
device.''.
(b) Provision of Additional Information.--Section 506C-1 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c-1) is amended--
(1) in the heading, by striking ``drug shortages'' and
inserting ``drug or device shortages'';
(2) by striking ``drug shortages'' each place it appears
and inserting ``drug or device shortages'';
(3) in subsection (a)--
(A) in paragraph (3)(B)--
(i) in clause (i), by striking ``section
506C(g)(1)'' and inserting ``paragraph (1) or
(2) of section 506C(g)''; and
(ii) in clause (ii), by striking ``section
506C(g)(2)'' and inserting ``section
506C(g)(3)''; and
(B) in paragraph (5), by striking ``drug shortage''
and inserting ``drug or device shortage''; and
(4) in subsection (c), by striking ```drug shortage' or''.
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