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.

Bill: 116-hr-6062
Sponsor: full_name: Rep. Schneider, Bradley Scott [D-IL-10]
Introduced: 2020-03-03
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Health technology, devices, supplies
Latest action: action_date: 2020-03-04
text: Sponsor introductory remarks on measure. (CR H1476)

Summaries:
action_date: 2020-03-03
action_desc: Introduced in House
text: <p>This bill expands existing requirements relating to supply shortages of life-saving drugs to also apply to life-saving medical devices. </p> <p>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.</p>

tv_txt: I 116th CONGRESS 2d Session H. R. 6062 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.

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 . 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 . 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 .