[Congressional Record Volume 166, Number 163 (Monday, September 21, 2020)]
[House]
[Pages H4616-H4618]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
NATIONAL CENTERS OF EXCELLENCE IN CONTINUOUS PHARMACEUTICAL
MANUFACTURING ACT OF 2020
Mrs. DINGELL. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 4866) 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. 4866
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 Continuous Pharmaceutical Manufacturing Act of
2020''.
SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN 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 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 Continuous Pharmaceutical Manufacturing Act of
2020, receive requests from institutions of higher education
to be designated as a National Center of Excellence in
Continuous Pharmaceutical Manufacturing (in this section
referred to as a `National Center of Excellence') to support
the advancement and development of continuous manufacturing;
and
``(2) shall so designate any institution of higher
education that--
``(A) requests such designation; and
``(B) meets 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 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 are that the institution has, as of the
date of the submission of a request under subsection (a) by
such institution--
``(1) physical and technical capacity for research and
development of continuous 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 entities;
``(3) proven capacity to design and demonstrate new, highly
effective technology for use in continuous manufacturing;
``(4) a track record for creating and transferring
knowledge with respect to continuous manufacturing;
``(5) the potential to train a future workforce for
research on and implementation of advanced manufacturing and
continuous manufacturing; and
``(6) experience in participating in and leading a
continuous manufacturing technology partnership with other
institutions of higher education, large and small
pharmaceutical manufacturers, generic and nonprescription
manufacturers, contract manufacturers, and other entities--
``(A) to support companies with continuous manufacturing in
the United States;
``(B) to support Federal agencies with technical
assistance, which may include regulatory and quality metric
guidance as applicable, for advanced manufacturing and
continuous manufacturing;
``(C) with respect to continuous manufacturing, to organize
and conduct research and development activities needed to
create new and more effective technology, capture and
disseminate expertise, create intellectual property, and
maintain technological leadership;
``(D) to develop best practices for designing continuous
manufacturing; and
``(E) to assess and respond to the workforce needs for
continuous manufacturing, including the development of
training programs if needed.
``(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 60
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 enter into an agreement with the Secretary
under which the institution 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
manufacturers) and another institution or institutions
designated under this section, if any, a roadmap for
developing a continuous manufacturing workforce;
``(4) to develop, along with industry partners and other
institutions designated under this section, a roadmap for
strengthening existing, and developing new, relationships
with other institutions; and
``(5) to provide an annual report to the Food and Drug
Administration regarding the institution's activities under
this section, including a description of how the institution
continues to meet and make progress on the criteria listed 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
continuous manufacturing, including such improvements as may
enable the Centers--
``(A) to continue to meet the conditions specified in
subsection (e); and
[[Page H4617]]
``(B) to expand capacity for research on, and development
of, continuing manufacturing.
``(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 continuous
manufacturing through the National Center of Excellence; and
``(B) be relevant to the mission of the Food and Drug
Administration.
``(3) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection $80,000,000
for the period of fiscal years 2021 through 2025.
``(4) 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;
and
``(B) 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
continuous manufacturing, including--
``(A) a national framework of principles related to the
implementation and regulation of continuous manufacturing;
``(B) a plan for the development of Federal regulations and
guidance for how advanced manufacturing and continuous
manufacturing can be incorporated into the development of
pharmaceuticals and regulatory responsibilities of the Food
and Drug Administration; and
``(C) appropriate feedback solicited from the public, which
may include other institutions, large and small
biopharmaceutical manufacturers, generic and nonprescription
manufacturers, and contract manufacturers.
``(h) Definitions.--In this section:
``(1) Advanced manufacturing.--The term `advanced
manufacturing' means an approach for the manufacturing of
pharmaceuticals that incorporates novel technology, or uses
an established technique or technology in a new or innovative
way (such as continuous manufacturing where the input
materials are continuously transformed within the process by
two or more unit operations) that enhances drug quality or
improves the manufacturing process.
``(2) Continuous manufacturing.--The term `continuous
manufacturing'--
``(A) means a process 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) consists of an integrated process that consists of a
series of two or more unit operations.
``(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.''.
(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.
The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from
Michigan (Mrs. Dingell) and the gentleman from Montana (Mr. Gianforte)
each will control 20 minutes.
The Chair recognizes the gentlewoman from Michigan.
General Leave
Mrs. DINGELL. Mr. 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. 4866.
The SPEAKER pro tempore. Is there objection to the request of the
gentlewoman from Michigan?
There was no objection.
Mrs. DINGELL. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, before I begin, I want to thank Chairman Pallone and
Ranking Member Walden for their bipartisan leadership on all of the
legislation before us today. During this unprecedented public health
crisis, and in spite of significant logistical challenges, the Energy
and Commerce Committee has come together on a bipartisan basis on
legislation to meaningfully address many public health issues we
continue to face.
I would also like to commend many of my fellow committee members for
their advocacy and efforts on the legislation before us today.
Mr. Speaker, I am proud to rise in support of H.R. 4866, the National
Centers of Excellence in Continuous Pharmaceutical Manufacturing Act.
{time} 1745
COVID-19 has made clear that the United States is overly reliant on
foreign manufacturers for critical products like personal protective
equipment and pharmaceuticals. For far too long, we have relied on
China and India to provide our necessary medicines and the ingredients
needed to make them. In times of crisis like COVID-19, access to
critical medicines is even more critical.
While there are many things we must do to encourage drug
manufacturing to come back to the United States, investing and
supporting the use of efficient, innovative technologies like
continuous manufacturing hold promise.
Continuous manufacturing allows manufacturers to make drugs more
efficiently, thereby improving the quality of drugs while also reducing
waste and the footprint needs that traditional drug manufacturing
requires.
FDA has been working to support increased utilization of this
technology because, as we have heard from the head of FDA's drug
center, Dr. Janet Woodcock, continuous manufacturing can help
``increase the resilience of our domestic manufacturing base and reduce
quality issues that trigger drug shortages or recalls.''
H.R. 4866 will help support this work by investing in centers of
excellence at universities that can help us to further improve this
technology, transfer it to drug manufacturers, and increase its use and
capability in the United States. These centers of excellence would also
be charged with helping to develop a domestic workforce that would be
able to help manufacturers with the adoption of continuous
manufacturing.
For States like mine, Michigan, centers of excellence supported by
H.R. 4866 could help to leverage our manufacturing expertise to support
the growth of a new generation of drug manufacturers in our own
backyard.
Now more than ever, we must work to bring drug manufacturing home to
ensure that our critical medicines are available without interruption
in public health emergencies or crises.
Mr. Speaker, I urge my colleagues to support this legislation, and I
reserve the balance of my time.
Mr. GIANFORTE. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today in support of H.R. 4866, the National
Centers of Excellence and Continuous Pharmaceutical Manufacturing Act
introduced by Chairman Pallone and Representative Guthrie.
This legislation would direct the FDA to designate higher education
institutions as national centers of excellence, allowing the FDA to
work with the centers and industry to create a national framework for
implementation of continuous manufacturing technology.
Last October, the Committee on Energy and Commerce held a hearing on
safeguarding the pharmaceutical supply chain. At this hearing, Dr.
Janet Woodcock, Director of the Center for Drug Evaluation and Research
at the FDA, spoke at length about the advantages of advanced
manufacturing technology, such as continuous manufacturing.
This included the potential to reduce our dependence on foreign
sources of active pharmaceutical ingredients, increase our
manufacturing resiliency, and reduce quality issues that often trigger
drug shortages. Increased adoption of these technologies could open the
door to a revived U.S. manufacturing base and lower production costs,
resulting in lower drug prices and a more stable drug supply.
Given the potential this technology holds, I am pleased we are moving
forward with this bipartisan legislation to further advance this
development. I
[[Page H4618]]
urge my colleagues to support this legislation, and I reserve the
balance of my time.
Mrs. DINGELL. Mr. Speaker, I reserve the balance of my time.
Mr. GIANFORTE. Mr. Speaker, I yield 3 minutes to the gentleman from
Kentucky (Mr. Guthrie).
Mr. GUTHRIE. Mr. Speaker, I rise today in support of H.R. 4866, the
National Centers of Excellence in Continuous Pharmaceutical
Manufacturing Act, a bill I introduced with my colleague, Energy and
Commerce Committee Chairman Frank Pallone.
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. 4866, which we are considering
today, builds on this partnership established in the Cures Act.
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.
Mr. Speaker, I urge my colleagues to support H.R. 4866.
Mrs. DINGELL. Mr. Speaker, I reserve the balance of my time.
Mr. GIANFORTE. Mr. Speaker, I urge adoption of this bill, and I yield
back the balance of my time.
Mrs. DINGELL. Mr. Speaker, it is time for the United States to focus
on bringing the production back home. I urge my colleagues to support
this legislation, and I yield back the balance of my time.
Mr. PALLONE. Mr. Speaker, I rise in support of H.R. 4866, the
National Centers of Excellence in Continuous Pharmaceutical
Manufacturing Act.
Continuous pharmaceutical manufacturing is the future of medicine.
This bipartisan bill, which I introduced with Representative Guthrie
last year, will foster the development of continuous manufacturing
technology, a more nimble and efficient mode of pharmaceutical
production. It does this by expanding opportunities for the Food and
Drug Administration (FDA) to partner with universities across the
country that are leading these efforts and create Centers of Excellence
for Continuous Pharmaceutical Manufacturing. The partnerships created
by the legislation will help develop continuous manufacturing
technology and standardization, develop a continuous manufacturing
workforce here in the United States, and make recommendations for how
FDA, industry, and others can expand the use of continuous
manufacturing for drugs and biologics.
The COVID-19 pandemic has demonstrated how the outdated batch
manufacturing process adds to the potential for supply chain issues.
During the initial stages of the outbreak in New Jersey, I heard from
health providers in my district about their inability to access
commonly used and critically needed medication, including medication
necessary for the use of ventilators, due to surges in demand. H.R.
4866 will help prevent supply chain interruptions like these by
increasing domestic manufacturing and allowing manufacturers to more
quickly adjust to sudden shifts in demand.
As Dr. Janet Woodcock, the Director for the Center for Drug
Evaluation and Research at FDA told the Energy and Commerce
Subcommittee on Health last year, advance manufacturing technologies--
such as continuous manufacturing--can help to ``reduce the Nation's
dependence on foreign sources of [active pharmaceutical ingredients],
increase the resilience of our domestic manufacturing base, and reduce
quality issues that trigger drug shortages or recalls.''
In other words, by passing this bill and expanding continuous
manufacturing technology in the United States, we can avoid future drug
shortages and other supply chain interruptions, while bringing jobs
back to the United States. This will help those on the frontlines
battling COVID-19 and the patients who are depending on them.
I want to thank Representative Guthrie for working with me on this
bill and demonstrating the collegial and bipartisan spirit of the
Energy and Commerce Committee. I urge all members to support this
important legislation.
The SPEAKER pro tempore. The question is on the motion offered by the
gentlewoman from Michigan (Mrs. Dingell) that the House suspend the
rules and pass the bill, H.R. 4866, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
____________________