Title: Securing America’s Medicine Cabinet Act of 2020
Policy area: Health

Summary:
Securing America's Medicine Cabinet Act of 2020
This bill encourages the development and approval of advanced pharmaceutical manufacturing technologies and designates certain university research centers to assist in developing such technologies.
The Food and Drug Administration (FDA) must continue to evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. The FDA must designate such a technology as an advanced manufacturing technology if it 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 design and manufacturing.
The sponsor of such a designated technology must provide the FDA with certain related scientific evidence. After receiving this evidence, if the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation.
The FDA must designate certain institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing. Among other requirements, such centers must demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies.

[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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