Title: To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes.
Policy area: Health

Summary:
This bill expands existing requirements relating to supply shortages of life-saving drugs to also apply to life-saving medical devices.
Generally, a manufacturer must (1) notify the Food and Drug Administration (FDA) of supply interruptions in certain circumstances, (2) provide for the expedited review of a new device that may mitigate the shortage, and (3) allow the FDA to authorize the importation of the device for emergency medical care.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6062 Introduced in House (IH)]

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116th CONGRESS
  2d Session
                                H. R. 6062

To amend certain provisions in the Federal Food, Drug, and Cosmetic Act 
  relating to the discontinuance or interruption in the production of 
 life-saving drugs so as to apply such provisions with respect to life-
                saving devices, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 3, 2020

 Mr. Schneider (for himself, Mr. Hice of Georgia, and Ms. Schakowsky) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend certain provisions in the Federal Food, Drug, and Cosmetic Act 
  relating to the discontinuance or interruption in the production of 
 life-saving drugs so as to apply such provisions with respect to life-
                saving devices, 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. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-
              SAVING DEVICES.

    (a) Notification Requirement.--Section 506C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356c) is amended--
            (1) in the section heading, by striking ``life-saving 
        drugs'' and inserting ``life-saving drugs and devices'';
            (2) in the matter preceding paragraph (1) in subsection 
        (a), by striking ``a drug'' and inserting ``a drug or device'';
            (3) in subsection (a)(1)(C), by striking ``such drug'' and 
        inserting ``such drug or device'';
            (4) in the matter following paragraph (2) in subsection 
        (a), by striking ``the drug'' each place it appears and 
        inserting ``the drug or device'';
            (5) in subsection (c), by striking ``the drugs'' and 
        inserting ``the drugs or devices'';
            (6) in the matter before paragraph (1) in subsection (g), 
        by striking ``a drug shortage of a drug described in subsection 
        (a)'' and inserting ``a drug or device shortage of a drug or 
        device described in subsection (a)'';
            (7) in subsection (g)(1), by striking ``or a supplement to 
        such an application submitted under section 505(j), that could 
        help mitigate or prevent such shortage'' and inserting ``a 
        supplement to such an application submitted under section 
        505(j), or a submission for clearance of a device under section 
        510(k), classification of a device under section 513(f)(2), or 
        approval of a device under section 515, that could help 
        mitigate or prevent such shortage'';
            (8) in subsection (g)(2), by striking ``such drug 
        shortage'' and inserting ``such drug or device shortage'';
            (9) in subsection (h), by amending paragraph (2) to read as 
        follows:
            ``(2) the term `drug or device shortage' or `shortage', 
        with respect to a drug or device, means a period of time when 
        the demand or projected demand for the drug or device within 
        the United States exceeds the supply of the drug or device; 
        and''; and
            (10) in subsection (h)(3)(A), by striking ``a drug'' and 
        inserting ``a drug or device''.
    (b) Annual Reporting on Shortages.--Section 506C-1 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356c-1) is amended--
            (1) in the section heading, by striking ``drug shortages'' 
        and inserting ``drug and device shortages'';
            (2) in subsections (a) and (b), by striking ``drug 
        shortages'' each place it appears and inserting ``drug and 
        device shortages'';
            (3) in subsection (a)(2), by striking ``the staff of the 
        Center for Drug Evaluation and Research's Office of Compliance 
        and Drug Shortage Program'' and inserting ``the staffs of the 
        Center for Drug Evaluation and Research's Office of Compliance 
        and Drug Shortage Program and the Center for Devices and 
        Radiological Health'';
            (4) in subsection (a)(3)(B)(i), by striking ``applications 
        and supplements'' and inserting ``applications, supplements, 
        and submissions''; and
            (5) in subsections (a)(5) and (c), by striking ``drug 
        shortage'' and inserting ``drug or device shortage''.

SEC. 2. DEVICE SHORTAGE LIST.

    (a) In General.--Section 506E of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356e) is amended--
            (1) in the section heading, by striking ``drug shortage 
        list'' and inserting ``drug and device shortage list''; and
            (2) in subsection (a), by striking ``list of drugs'' and 
        inserting ``list of drugs and devices''.
    (b) Contents.--Section 506E(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356e(b)) is amended--
            (1) in the matter before paragraph (1), by striking ``each 
        drug'' and inserting ``each drug and device'';
            (2) by striking ``the drug'' each place it appears and 
        inserting ``the drug or device'';
            (3) in paragraph (1), by striking ``the National Drug Code 
        number for such drug'' and inserting ``the National Drug Code 
        number for any such drug''; and
            (4) in paragraph (2), by striking ``such drug'' and 
        inserting ``such device''.
    (c) Public Availability Public Health Exception.--Section 506E(c) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e(b)) is 
amended by striking ``drug products'' and inserting ``drug products or 
devices''.
    (d) Technical Corrections.--Effective as if included in the 
enactment of the 21st Century Cures Act (Public Law 114-255), section 
3101(a)(2)(G) of such Act is amended, in the amendments made by such 
section to section 506E(b)(3)(E) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356e(b)(3)(E))--
            (1) by striking ``discontinuation'' and inserting 
        ``Discontinuation''; and
            (2) by striking ``discontinuance'' and inserting 
        ``Discontinuance''.

SEC. 3. IMPORTATION OF DEVICES IN SHORTAGE.

    Section 801(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(d)) is amended--
            (1) in paragraph (1), by adding at the end the following 
        subparagraph:
    ``(C) Except as authorized by the Secretary in the case of a device 
that appears on the drug and device shortage list under section 506E, 
no device may be imported into the United States for commercial use if 
such device is manufactured outside the United States, unless the 
manufacturer has authorized the device to be marketed in the United 
States and has caused the device to be labeled to be marketed in the 
United States.''; and
            (2) in paragraph (2), by striking ``drug'' each place it 
        appears and inserting ``drug or device''.
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