Title: PART Act
Policy area: Health

Summary:
Pharmaceutical Accountability, Responsibility, and Transparency Act or the PART Act
This bill expands requirements for manufacturers of certain drugs and medical devices to report information to the Food and Drug Administration (FDA) and contains related provisions.
A manufacturer of a life-saving drug or medical device must notify the FDA of certain issues that may affect the drug or device's availability, such as an increase in demand that the manufacturer is likely unable to meet or an export restriction imposed by a foreign country where the drug or device is being manufactured. The manufacturer must notify the FDA within five days of becoming aware of the issue.
The bill also expands the types of foreign manufacturers of drugs and medical devices that must register with the FDA. Additionally, the bill expands a requirement for registered manufacturers to submit periodic reports to the FDA by (1) increasing the frequency of such reports, and (2) requiring the reports to include additional information about the amounts of drugs and medical devices being manufactured.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3781 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  2d Session
                                S. 3781

To increase reporting of, help mitigate potential shortages related to, 
 and promote, accountability and transparency for pharmaceuticals and 
                            medical devices.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 20, 2020

  Mr. Peters introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To increase reporting of, help mitigate potential shortages related to, 
 and promote, accountability and transparency for pharmaceuticals and 
                            medical devices.

    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 ``Pharmaceutical Accountability, 
Responsibility, and Transparency Act'' or the ``PART Act''.

SEC. 2. FDA INCREASED DEMAND REPORTING WITH RESPECT TO DRUGS.

    Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356c), as amended by the CARES Act (Public Law 116-136), is further 
amended--
            (1) in subsections (c), (e), (f), (g), and (j), by 
        inserting ``or (k)'' after ``subsection (a)'' each place such 
        term appears; and
            (2) by adding at the end the following:
    ``(k) Increased Demand Reporting.--
            ``(1) In general.--The manufacturer of a drug described in 
        subsection (a) or a biological product subject to subsection 
        (i)(3) shall notify the Secretary, in accordance with paragraph 
        (2), of any--
                    ``(A) increase in demand for the drug that the 
                manufacturer likely will be unable to meet; or
                    ``(B) export restrictions or other limitations 
                imposed, on or after the date of enactment of the PART 
                Act, on manufacturing or shipment of the drug or any of 
                its active pharmaceutical ingredients by the country in 
                which such drug or any such ingredient is manufactured.
            ``(2) Timing.--A notice required under paragraph (1) shall 
        be submitted to the Secretary as soon as practicable but not 
        later than 5 calendar days after the manufacturer becomes aware 
        of the issue requiring notification under such paragraph.
            ``(3) Notification of resolution of issue.--A manufacturer 
        of a drug who submits a notification to the Secretary under 
        paragraph (1) shall notify the Secretary after the issue giving 
        rise to such notification has been resolved or when the 
        manufacturer is able to meet demand.''.

SEC. 3. FDA INCREASED DEMAND REPORTING WITH RESPECT TO DEVICES.

    Section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356c) is amended--
            (1) in subsections (c), (e), and (f), by inserting ``or 
        (j)'' after ``subsection (a)'' each place such term appears; 
        and
            (2) by adding at the end the following:
    ``(j) Increased Demand Reporting.--
            ``(1) In general.--The manufacturer of a device described 
        in subsection (a) shall notify the Secretary, in accordance 
        with paragraph (2), of any--
                    ``(A) increase in demand for the device that the 
                manufacturer likely will be unable to meet; or
                    ``(B) export restrictions or other limitations 
                imposed, on or after the date of enactment of the PART 
                Act, on manufacturing or export of the device by the 
                country in which such device or any component of the 
                device is manufactured.
            ``(2) Timing.--A notice required under paragraph (1) shall 
        be submitted to the Secretary as soon as practicable but not 
        later than 5 calendar days after the manufacturer becomes aware 
        of the issue requiring notification under such paragraph.
            ``(3) Notification of resolution of issue.--A manufacturer 
        of a device who submits a notification to the Secretary under 
        paragraph (1) shall notify the Secretary after the issue giving 
        rise to such notification has been resolved or when the 
        manufacturer is able to meet demand.''.

SEC. 4. QUARTERLY MANUFACTURER REPORTING WITH RESPECT TO DRUGS AND 
              DEVICES.

    (a) Registration of Certain Foreign Establishments.--Section 510(i) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is 
amended by inserting at the end the following new paragraph:
    ``(5) The requirements of paragraphs (1) and (2) shall apply to 
establishments within a foreign country engaged in the manufacture, 
preparation, propagation, compounding, or processing of any drug, 
including the active pharmaceutical ingredient, or device that is 
required to be listed pursuant to subsection (j). Such requirements 
shall apply regardless of whether the drug, active pharmaceutical 
ingredient, or device undergoes further manufacture, preparation, 
propagation, compounding, or processing at a separate establishment or 
establishments outside the United States prior to being imported or 
offered for import into the United States.''.
    (b) Listing of Drugs.--Section 510(j)(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360(j)(1)) is amended--
            (1) in subparagraph (D), by striking ``and'' at the end;
            (2) in subparagraph (E), by striking the period at the end 
        and inserting ``; and''; and
            (3) by adding at the end the following new subparagraph:
            ``(F) in the case of a drug contained in the applicable 
        list, a certification that the registrant has--
                    ``(i) identified every other establishment where 
                manufacturing is performed for the drug; and
                    ``(ii) notified each known foreign establishment 
                engaged in the manufacture, preparation, propagation, 
                compounding, or processing of the drug, including the 
                active pharmaceutical ingredient, of the inclusion of 
                the drug in the list and the obligation to register 
                under subsection (i)(5).''.
    (c) Quarterly Reporting.--Paragraph (3) of section 510(j) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)), as amended by 
the CARES Act (Public Law 116-136), is amended to read as follows:
    ``(3)(A) Subject to subparagraph (C) each person who registers with 
the Secretary under this section shall submit to the Secretary 
quarterly reports, in such electronic data format as the Secretary 
requires, containing the following information, as applicable, with 
respect to all drugs, drug substances, and devices manufactured, 
prepared, propagated, compounded, or processed at the establishment, 
whether for import into the United States or distribution in another 
country:
            ``(i) With respect to a finished drug product--
                    ``(I) the number of dosage units manufactured at 
                each establishment since the last report, broken down 
                by--
                            ``(aa) the number of dosage units 
                        manufactured at each establishment at which 
                        final manufacturing occurred, and the unique 
                        facility identifier of each such establishment;
                            ``(bb) the number of dosage units from each 
                        such establishment that were distributed (or 
                        are intended to be distributed) for use in the 
                        United States and the number of dosage units 
                        that were distributed (or are intended to be 
                        distributed) for use outside of the United 
                        States; and
                    ``(II) the sources of drug substances used in the 
                manufacturing of the finished drug product, and, for 
                each such source--
                            ``(aa) the unique facility identifier of 
                        each source of drug substance; and
                            ``(bb) the number of dosage units of the 
                        finished drug product manufactured using that 
                        drug substance from each source of drug 
                        substance; and
                    ``(III) the National Drug Code number.
            ``(ii) With respect to a drug substance--
                    ``(I) the amount of drug substance manufactured at 
                each establishment since the last report and the unique 
                facility identifier of each such establishment;
                    ``(II) the amount of the drug substance 
                manufactured at each such establishment that was 
                distributed (or are intended to be distributed) for use 
                in the United States and the amount that was 
                distributed (or are intended to be distributed) for use 
                outside of the United States; and
                    ``(III) the National Drug Code number.
            ``(iii) With respect to a device, the number of units 
        manufactured at each establishment since the last report, 
        broken down by--
                    ``(I) the number of units manufactured at each 
                establishment at which final manufacturing occurred, 
                and the establishment identification number of each 
                such establishment; and
                    ``(II) the number of units from each such 
                establishment that were distributed (or are intended to 
                be distributed) for use in the United States and the 
                number of units that were distributed (or are intended 
                to be distributed) for use outside of the United 
                States.
    ``(B) By order of the Secretary, certain biological products or 
categories of biological products may be exempt from some or all of the 
reporting requirements under subparagraph (A), if the Secretary 
determines, at the Secretary's sole discretion, that applying such 
reporting requirements to such biological products or categories is not 
necessary to protect the public health.
    ``(C) The determination of the appropriate structured electronic 
data format by the Secretary under subparagraph (A), whether to exempt 
certain biological products or categories of biological products under 
subparagraph (B), and the date on which reporting begins under this 
section shall be exempt from the requirements of section 553 of title 
5, United States Code.''.
    (d) Effective Date.--The amendments made by this section shall take 
effect on September 23, 2020.
    (e) Confidentiality.--Nothing in the amendments made by this 
section shall be construed as authorizing the Secretary to disclose any 
information that is a trade secret or confidential information subject 
to section 552(b)(4) of title 5, United States Code, or section 1905 of 
title 18, United States Code.

SEC. 5. REQUIRING FDA TO SHARE MANUFACTURING INFORMATION WITH ASPR AND 
              THE ASSISTANT SECRETARY OF DEFENSE FOR HEALTH AFFAIRS.

    (a) In General.--Beginning as soon as practicable, but not later 
than 1 year after the date of enactment of this Act, the Secretary of 
Health and Human Services, acting through the Commissioner of Food and 
Drugs, shall provide to the Assistant Secretary for Preparedness and 
Response and the Assistant Secretary of Defense for Health Affairs all 
drug and device manufacturing data described in subsection (b), as 
appropriate and applicable, for any of the following purposes:
            (1) Maintaining the strategic national stockpile under 
        section 319F-2 of the Public Health Service Act (42 U.S.C. 
        247d-6b).
            (2) Evaluating health infrastructure under the Division of 
        Critical Infrastructure Protection of the Office of the 
        Assistant Secretary for Preparedness and Response.
            (3) Preparing for and responding to public health 
        emergencies and national security concerns.
            (4) Mitigating potential drug shortages.
    (b) Reporting Provisions.--The drug and device manufacturing data 
required to be provided as described in subsection (a) includes--
            (1) information reported by any manufacturer under 
        subsection (a) or (k) of section 506C(a) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 356c) or subsection (a) or 
        (j) of section 506J of such Act (21 U.S.C. 356j);
            (2) any risk management plan under section 506C(j) of such 
        Act (21 U.S.C. 356c(j)) that is made available to the Secretary 
        pursuant to such section;
            (3) records or other information provided under section 
        704(a)(4) of such Act (21 U.S.C. 374(a)(4)); and
            (4) to the extent not already provided, the locations where 
        each drug that is a subject of a report or plan under paragraph 
        (1), (2), or (3) is manufactured.
    (c) Memoranda of Understanding.--The Commissioner of Food and Drugs 
and the Assistant Secretary for Preparedness and Response, and the 
Commissioner of Food and Drugs and the Assistant Secretary of Defense 
for Health Affairs, shall enter into memoranda of understanding to set 
forth the manner in which data will be shared under this section and 
the procedures for protecting any nonpublic data from further 
disclosure.
                                 <all>