September 21, 2020 - Issue: Vol. 166, No. 163 — Daily Edition116th Congress (2019 - 2020) - 2nd Session

[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.

                          ____________________