[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3432 Introduced in Senate (IS)]
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116th CONGRESS
2d Session
S. 3432
To support the advanced manufacturing technologies program of the Food
and Drug Administration, to establish National Centers of Excellence in
Advanced Pharmaceutical Manufacturing, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 10, 2020
Mrs. Blackburn (for herself and Mr. Menendez) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To support the advanced manufacturing technologies program of the Food
and Drug Administration, to establish National Centers of Excellence in
Advanced Pharmaceutical Manufacturing, 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 ``Securing America's Medicine Cabinet
Act of 2020''.
SEC. 2. ADVANCED MANUFACTURING TECHNOLOGIES PROGRAM.
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. ADVANCED MANUFACTURING TECHNOLOGIES PROGRAM.
``(a) In General.--Not later than 1 year after the date of
enactment of the Securing America's Medicine Cabinet Act of 2020, the
Secretary shall continue in effect the program to evaluate and approve
new drug manufacturing technologies that are included in an
application, or supplement to an application, for a drug under
subsection (b) or (j) of section 505 of this Act or for a biological
product submitted under subsection (a) or (k) of section 351 of the
Public Health Service Act.
``(b) Designation.--The Secretary shall designate a method of
manufacturing a drug as an advanced manufacturing technology under this
section if the drug manufacturer demonstrates that such technology is
likely to--
``(1) prevent or resolve a drug shortage;
``(2) maintain an adequate supply of critical medications
for national emergencies; or
``(3) promote the adoption of innovative approaches to drug
product design and manufacturing.
``(c) Consultation.--If the Secretary designates a method of
manufacturing as an advanced manufacturing technology under this
section, the Secretary shall take actions to expedite the development
and implementation of such method of manufacture for purposes of
approval of the application under subsection (c) or (j) of section 505
of this Act or subsection (a) or (k) of section 351 of the Public
Health Service Act, which may include, as appropriate--
``(1) holding meetings between the sponsor of the
application and appropriate Food and Drug Administration staff
throughout the development of the technology;
``(2) providing timely advice to, and interactive
communication with, the sponsor regarding the development of
the technology; and
``(3) involving senior managers and experienced staff of
the Food and Drug Administration, as appropriate, in a
collaborative, cross-disciplinary review of the method of
manufacturing.
``(d) Evaluation of an Advanced Manufacturing Technology.--
``(1) Package.--A sponsor who receives designation of an
advanced manufacturing technology under this section shall
provide the Secretary with a package of scientific evidence
supporting the implementation of the advanced manufacturing
technology in a particular context-of-use.
``(2) Evaluation.--Within 90 days of receiving the package,
the Secretary shall determine whether a designated advanced
manufacturing technology is validated for the proposed context
of use based on the scientific merit the supporting evidence
provided by the sponsor.
``(3) Effect of approval.--Upon approval, the same sponsor
may rely upon the advanced manufacturing technology for use
across multiple manufacturing product lines within the same
context-of-use without having to re-submit data to the
Secretary validating the underlying technology.
``(e) Implementation and Reporting.--
``(1) Public meeting.--The Secretary shall publish in the
Federal Register a notice of a public meeting to be held no
later than 1 year after the date of enactment of the Securing
America's Medicine Cabinet Act of 2020 to discuss and obtain
input and recommendations from stakeholders regarding the goals
and scope of, and a suitable framework and procedures and
requirements for, the program under this section.
``(2) Program guidance.--The Secretary shall--
``(A) not later than 1 year after the date of
enactment of the Securing America's Medicine Cabinet
Act of 2020, issue draft guidance regarding the goals
and implementation of the program under this section;
and
``(B) not later than 2 years after the date of
enactment of the Securing America's Medicine Cabinet
Act of 2020, issue final guidance with respect to the
implementation of such program.
``(3) Report.--The Secretary shall make available on the
internet website of the Food and Drug Administration an annual
report on the progress of the program under this section.''.
SEC. 3. NATIONAL CENTER OF EXCELLENCE IN ADVANCED PHARMACEUTICAL
MANUFACTURING.
Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
391 et seq.) is amended by adding at the end the following:
``SEC. 1015. NATIONAL CENTER OF EXCELLENCE IN ADVANCED PHARMACEUTICAL
MANUFACTURING.
``(a) In General.--The Secretary shall designate institutions of
higher education as National Centers of Excellence in Advanced
Pharmaceutical Manufacturing, including continuous pharmaceutical
manufacturing.
``(b) Eligibility.--To be eligible for designation under subsection
(a) an entity shall--
``(1) be an institution of higher education;
``(2) demonstrate--
``(A) the physical and technical capacity for
research and development of advanced pharmaceutical
manufacturing;
``(B) a record of transferring scientific knowledge
to the marketplace;
``(C) scalable manufacturing knowledge, which may
be through collaborations of other institutions of
higher education, biopharmaceutical manufacturers, or
other entities;
``(D) the ability to train a future workforce for
research on and implementation of advanced
pharmaceutical manufacturing; and
``(E) the ability to support Federal agencies with
technical assistance for advanced pharmaceutical
technologies, with an emphasis on creating a secure
national pharmaceutical stockpile and the ability to
rapidly address drug shortages; and
``(3) submit an application to the Secretary at such time,
in such form, and in such manner as the Secretary may require.
``(c) Termination.--The Secretary may terminate the designation of
an entity designated under subsection (a) upon a determination that the
entity no longer meets the requirements of subsection (b).
``(d) Annual Report.--Not later than 1 year after the date on which
the first designation is made under subsection (a), and annually
thereafter, the Secretary shall submit a report to Congress on the
activities of the entities designated under such subsection.
``(e) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $100,000,000 for the period of
fiscal year 2021 through 2025.''.
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