[Congressional Record Volume 167, Number 183 (Tuesday, October 19, 2021)]
[House]
[Pages H5645-H5647]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND CONTINUOUS
PHARMACEUTICAL MANUFACTURING ACT OF 2021
Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the
bill (H.R. 4369) to amend the 21st Century Cures Act to provide for
designation of institutions of higher education that provide research,
data, and leadership on continuous manufacturing as National Centers of
Excellence in Continuous Pharmaceutical Manufacturing, and for other
purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 4369
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 ``National Centers of
Excellence in Advanced and Continuous Pharmaceutical
Manufacturing Act of 2021''.
[[Page H5646]]
SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND
CONTINUOUS PHARMACEUTICAL MANUFACTURING.
(a) In General.--Section 3016 of the 21st Century Cures Act
(21 U.S.C. 399h) is amended to read as follows:
``SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND
CONTINUOUS PHARMACEUTICAL MANUFACTURING.
``(a) In General.--The Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs--
``(1) shall solicit and, beginning not later than one year
after the date of enactment of the National Centers of
Excellence in Advanced and Continuous Pharmaceutical
Manufacturing Act of 2021, receive requests from institutions
of higher education, or consortia of institutions of higher
education, to be designated as a National Center of
Excellence in Advanced and Continuous Pharmaceutical
Manufacturing (in this section referred to as a `National
Center of Excellence') to support the advancement,
development, and implementation of advanced and continuous
pharmaceutical manufacturing; and
``(2) shall so designate not more than 5 institutions of
higher education or consortia of such institutions that--
``(A) request such designation; and
``(B) meet the criteria specified in subsection (c).
``(b) Request for Designation.--A request for designation
under subsection (a) shall be made to the Secretary at such
time, in such manner, and containing such information as the
Secretary may require. Any such request shall include a
description of how the institution of higher education, or
consortium of institutions of higher education, meets or
plans to meet each of the criteria specified in subsection
(c).
``(c) Criteria for Designation Described.--The criteria
specified in this subsection with respect to an institution
of higher education, or consortium of institutions of higher
education, are that the institution or consortium has, as of
the date of the submission of a request under subsection (a)
by such institution or consortium--
``(1) physical and technical capacity for research,
development, implementation, and demonstration of advanced
and continuous pharmaceutical manufacturing;
``(2) manufacturing knowledge-sharing networks with other
institutions of higher education, large and small
pharmaceutical manufacturers, generic and nonprescription
manufacturers, contract manufacturers, and other relevant
entities;
``(3) proven capacity to design, develop, implement, and
demonstrate new, highly effective technologies for use in
advanced and continuous pharmaceutical manufacturing;
``(4) a track record for creating, preserving, and
transferring knowledge with respect to advanced and
continuous pharmaceutical manufacturing;
``(5) the proven ability to facilitate training of an
adequate future workforce for research on, and implementation
of, advanced and continuous pharmaceutical manufacturing; and
``(6) experience in participating in and leading advanced
and continuous pharmaceutical manufacturing technology
partnerships with other institutions of higher education,
large and small pharmaceutical manufacturers, generic and
nonprescription manufacturers, contract manufacturers, and
other relevant entities--
``(A) to support companies seeking to implement advanced
and continuous pharmaceutical manufacturing in the United
States;
``(B) to support Federal agencies with technical assistance
and employee training, which may include regulatory and
quality metric guidance as applicable, and hands-on training,
for advanced and continuous pharmaceutical manufacturing;
``(C) with respect to advanced and continuous
pharmaceutical manufacturing, to organize and conduct
research and development activities needed to create new and
more effective technology, develop and share knowledge,
create intellectual property, and maintain technological
leadership;
``(D) to develop best practices for designing and
implementing advanced and continuous pharmaceutical
manufacturing processes; and
``(E) to assess and respond to the national workforce needs
for advanced and continuous pharmaceutical manufacturing,
including the development and implementing of training
programs.
``(d) Termination of Designation.--The Secretary may
terminate the designation of any National Center of
Excellence designated under this section if the Secretary
determines such National Center of Excellence no longer meets
the criteria specified in subsection (c). Not later than 90
days before the effective date of such a termination, the
Secretary shall provide written notice to the National Center
of Excellence, including the rationale for such termination.
``(e) Conditions for Designation.--As a condition of
designation as a National Center of Excellence under this
section, the Secretary shall require that an institution of
higher education or consortium of institutions of higher
education enter into an agreement with the Secretary under
which the institution or consortium agrees--
``(1) to collaborate directly with the Food and Drug
Administration to publish the reports required by subsection
(g);
``(2) to share data with the Food and Drug Administration
regarding best practices and research generated through the
funding under subsection (f);
``(3) to develop, along with industry partners (which may
include large and small biopharmaceutical manufacturers,
generic and nonprescription manufacturers, and contract
research organizations or contract manufacturers that carry
out drug development and manufacturing activities) and
another institution or consortium designated under this
section, if any, a roadmap for developing an advanced and
continuous pharmaceutical manufacturing workforce;
``(4) to develop, along with industry partners and other
institutions or consortia of such institutions designated
under this section, a roadmap for strengthening existing, and
developing new, relationships with other institutions of
higher education or consortia thereof; and
``(5) to provide an annual report to the Food and Drug
Administration regarding the institution's or consortium's
activities under this section, including a description of how
the institution or consortium continues to meet and make
progress on the criteria specified in subsection (c).
``(f) Funding.--
``(1) In general.--The Secretary shall award funding,
through grants, contracts, or cooperative agreements, to the
National Centers of Excellence designated under this section
for the purpose of studying and recommending improvements to
advanced and continuous pharmaceutical manufacturing,
including such improvements as may enable the Centers--
``(A) to continue to meet the conditions specified in
subsection (e);
``(B) to expand capacity for research on, and development
of, advanced and continuous pharmaceutical manufacturing; and
``(C) to implement research infrastructure in advanced and
continuous pharmaceutical manufacturing suitable for
accelerating the development of drug products needed to
respond to emerging medical threats, such as emerging drug
shortages, quality issues disrupting the supply chain,
epidemics and pandemics, and other such situations requiring
the rapid development of new products or new manufacturing
processes.
``(2) Consistency with fda mission.--As a condition on
receipt of funding under this subsection, a National Center
of Excellence shall agree to consider any input from the
Secretary regarding the use of funding that would--
``(A) help to further the advancement of advanced and
continuous pharmaceutical manufacturing through the National
Center of Excellence; and
``(B) be relevant to the mission of the Food and Drug
Administration.
``(3) Rule of construction.--Nothing in this section shall
be construed as precluding a National Center for Excellence
designated under this section from receiving funds under any
other provision of this Act or any other Federal law.
``(g) Annual Review and Reports.--
``(1) Annual report.--Beginning not later than one year
after the date on which the first designation is made under
subsection (a), and annually thereafter, the Secretary
shall--
``(A) submit to Congress a report describing the
activities, partnerships and collaborations, Federal policy
recommendations, previous and continuing funding, and
findings of, and any other applicable information from, the
National Centers of Excellence designated under this section;
``(B) include in such report an accounting of the Federal
administrative expenses described in subsection (i)(2) over
the reporting period; and
``(C) make such report available to the public in an easily
accessible electronic format on the website of the Food and
Drug Administration.
``(2) Review of national centers of excellence and
potential designees.--The Secretary shall periodically review
the National Centers of Excellence designated under this
section to ensure that such National Centers of Excellence
continue to meet the criteria for designation under this
section.
``(3) Report on long-term vision of fda role.--Not later
than 2 years after the date on which the first designation is
made under subsection (a), the Secretary, in consultation
with the National Centers of Excellence designated under this
section, shall submit a report to the Congress on the long-
term vision of the Department of Health and Human Services on
the role of the Food and Drug Administration in supporting
advanced and continuous pharmaceutical manufacturing,
including--
``(A) a national framework of principles related to the
implementation and regulation of advanced and continuous
pharmaceutical manufacturing;
``(B) a plan for the development of Federal regulations and
guidance for how advanced and continuous pharmaceutical
manufacturing can be incorporated into the development of
pharmaceuticals and regulatory responsibilities of the Food
and Drug Administration;
``(C) a plan for development of Federal regulations or
guidance for how advanced and continuous pharmaceutical
manufacturing will be reviewed by the Food and Drug
Administration; and
``(D) appropriate feedback solicited from the public, which
may include other institutions of higher education, large and
small biopharmaceutical manufacturers, generic and
nonprescription manufacturers, and contract manufacturers.
``(h) Definitions.--In this section:
``(1) Advanced.--The term `advanced', with respect to
pharmaceutical manufacturing, refers to an approach that
incorporates novel technology, or uses an established
technique or technology in a new or innovative way, that
enhances drug quality or improves the performance of a
manufacturing process.
``(2) Continuous.--The term `continuous', with respect to
pharmaceutical manufacturing, refers to a process--
``(A) where the input materials are continuously fed into
and transformed within the process, and the processed output
materials are continuously removed from the system; and
``(B) that consists of an integrated process that consists
of a series of two or more simultaneous unit operations.
[[Page H5647]]
``(3) Institution of higher education.--The term
`institution of higher education' has the meaning given such
term in section 101(a) of the Higher Education Act of 1965
(20 U.S.C. 1001(a)).
``(4) Secretary.--The term `Secretary' means the Secretary
of Health and Human Services, acting through the Commissioner
of Food and Drugs.
``(i) Authorization of Appropriations.--
``(1) In general.--There is authorized to be appropriated
to carry out this section $100,000,000 for the period of
fiscal years 2022 through 2026.
``(2) Federal administrative expenses.--Of the amounts made
available to carry out this section for a fiscal year, the
Secretary shall not use more than eight percent for Federal
administrative expenses, including training, technical
assistance, reporting, and evaluation.''.
(b) Transition Rule.--Section 3016 of the 21st Century
Cures Act (21 U.S.C. 399h), as in effect on the day before
the date of the enactment of this section, shall apply with
respect to grants awarded under such section before such date
of enactment.
(c) Clerical Amendment.--The item relating to section 3016
in the table of contents in section 1(b) of the 21st Century
Cures Act (Public Law 114-255) is amended to read as follows:
``Sec. 3016. National Centers of Excellence in Advanced and Continuous
Pharmaceutical Manufacturing.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Kentucky (Mr. Guthrie) each
will control 20 minutes.
The Chair recognizes the gentleman from New Jersey.
General Leave
Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on H.R. 4369.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Madam Speaker, I yield myself such time as I may
consume.
Madam Speaker, my colleagues and I on the Energy and Commerce
Committee have been working on legislation to invest in and support
American pharmaceutical manufacturing to reduce our dependence on items
produced abroad, such as active ingredients and raw materials. As the
COVID-19 pandemic has made clear, domestic pharmaceutical manufacturing
is critical to our Nation's public health and global economic
competitiveness.
The bill before us now, H.R. 4369, would leverage the expertise and
ingenuity of academic institutions in the United States to help support
and develop advanced manufacturing technologies right here at home. The
legislation will improve the quality of our pharmaceuticals, reduce
drug shortages, and help to produce more nimble and efficient
manufacturing processes that could be replicated throughout the Nation.
Specifically, H.R. 4369 would direct the Food and Drug Administration
to designate a number of American academic institutions as national
centers of excellence. It then provides funding to these centers to
develop advanced and continuous manufacturing.
Now, continuous manufacturing is an emerging technology whereby a
finished product is produced in a continuous stream, making it more
efficient than the current so-called batch model that can be slow and
may be subject to the risk of defects or errors during the
manufacturing process.
The centers would be required to work closely with the FDA and
industry to support regulatory guidance and expertise, catalyze
research and development in advanced and continuous manufacturing
technologies, and cultivate an advanced pharmaceutical manufacturing
workforce here in the United States.
The legislation requires that the majority of the $100 million in
funding be awarded directly to the designated centers of excellence,
while also providing resources for FDA technical assistance, guidance,
or training.
H.R. 4369 sets us on the right track for advanced manufacturing here
at home.
This legislation passed the House last Congress but was not taken up
in the Senate. If we are to meet the goal and demand for uninterrupted
access and supply of critical drugs and active pharmaceutical
ingredients, the time to act is now.
I want to thank our Health Subcommittee Ranking Member Guthrie for
working with me on this legislation, as well as full committee Ranking
Member Rodgers and Health Subcommittee Chairwoman Anna Eshoo.
I urge my colleagues to support H.R. 4369, and I hope the Senate will
follow suit so that we can finally expand advanced and continuous
manufacturing technology here in the United States.
Madam Speaker, I reserve the balance of my time.
Mr. GUTHRIE. Madam Speaker, I yield myself such time as I may
consume.
Madam Speaker, I rise today in support of H.R. 4369, the National
Centers of Excellence in Advanced and Continuous Pharmaceutical
Manufacturing Act, a bill I introduced with my colleague, Energy and
Commerce Committee Chairman Frank Pallone. I enjoyed working with him
on this bill.
In 2016, I was proud to work with my fellow committee members on the
21st Century Cures Act, which included legislation to issue grants for
institutions of higher education to study the process of continuous
pharmaceutical manufacturing.
H.R. 4369, which we are considering today, builds on this partnership
established in the Cures Act. Advanced and continuous manufacturing for
pharmaceuticals is a new technology that allows for drugs to be
produced in a continuous stream, helping drugs get into the market
faster.
This is something that has become increasingly important during the
COVID-19 pandemic. We need to ensure that our drug supply chain does
not depend too heavily on other countries, such as China.
I urge my colleagues to support H.R. 4369, and I reserve the balance
of my time.
Mr. PALLONE. Madam Speaker, I have no additional speakers. I am
prepared to close, and I reserve the balance of my time.
Mr. GUTHRIE. Madam Speaker, this is an important bill. We have all
seen what happened with COVID-19, our dependence on the global supply
chain, particularly in pharmaceuticals. It is a national security issue
that we have our own production here.
As we saw, we have had shortages during the height of the pandemic,
and we are still experiencing other supply chain issues. As we know,
those will work themselves out.
Having access to our own pharmaceuticals is not a luxury that we have
time for them to work out themselves. We are hopeful that we will get
things moving again in a normal supply chain, but we absolutely must
take the action necessary to make sure that we make it in America, and
we don't depend on countries such as China.
Madam Speaker, I urge the passage of this bill. I yield back the
balance of my time.
Mr. PALLONE. Madam Speaker, I, too, would say this is an important
bill, both from the point of view of moving toward more domestic
manufacturing and addressing the supply chain shortages that we saw
during COVID-19 for drugs.
Madam Speaker, I ask for Members to support this bill, and I yield
back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from New Jersey (Mr. Pallone) that the House suspend the
rules and pass the bill, H.R. 4369, as amended.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. PALLONE. Madam Speaker, on that I demand the yeas and nays.
The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution
8, the yeas and nays are ordered.
Pursuant to clause 8 of rule XX, further proceedings on this motion
are postponed.
____________________