Title: Mitigating Emergency Drug Shortages Act
Policy area: Health

Summary:
Mitigating Emergency Drug Shortages Act
This bill requires the Food and Drug Administration (FDA) to prioritize the review of life-saving or life-sustaining drugs that are facing shortages. The bill also requires manufacturers to report certain information to the FDA when there is a permanent discontinuance or interruption in the manufacture of active pharmaceutical ingredients for such drugs.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2723 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 2723

   To amend the Federal Food, Drug, and Cosmetic Act to reduce drug 
                   shortages, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 29, 2019

Ms. Collins (for herself and Ms. Smith) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to reduce drug 
                   shortages, 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 ``Mitigating Emergency Drug Shortages 
Act''.

SEC. 2. PRIORITIZE REVIEWS OF DRUG APPLICATIONS; INCENTIVES.

    (a) Prioritized Reviews and Inspections.--Section 506C(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(g)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``the Secretary may'' and inserting ``the Secretary shall'';
            (2) in paragraph (1), by inserting ``prioritize and'' 
        before ``expedite the review''; and
            (3) in paragraph (2), by inserting ``prioritize and'' 
        before ``expedite an inspection''.
    (b) Report.--Not later than one year after the date of enactment of 
this Act, the Secretary of Health and Human Services shall develop and 
submit to the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce of the House of 
Representatives a report containing legislative and regulatory 
recommendations--
            (1) to create market-based incentives or other appropriate 
        mechanisms, sufficient to encourage--
                    (A) the manufacture of drugs in shortage or at risk 
                of shortage;
                    (B) the domestic manufacture of finished dosage 
                forms of such drugs; and
                    (C) the domestic manufacture of active 
                pharmaceutical ingredients for such drugs; and
            (2) to expand the Emerging Technology Program of the Food 
        and Drug Administration to create or upgrade existing 
        technologies to address drug shortage challenges and promote 
        modern, reliable manufacturing strategies.

SEC. 3. ADDITIONAL MANUFACTURER REPORTING REQUIREMENTS IN RESPONSE TO 
              DRUG SHORTAGES.

    (a) Expansion To Include Active Pharmaceutical Ingredients.--
Subsection (a) of section 506C of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356c) is amended--
            (1) in the matter preceding paragraph (1), by inserting 
        ``or its active pharmaceutical ingredients'' after ``a drug''; 
        and
            (2) in the flush text at the end--
                    (A) by inserting ``or its active pharmaceutical 
                ingredients'' before ``that is likely'';
                    (B) ``or its active pharmaceutical ingredients'' 
                after ``that drug''; and
                    (C) by adding at the end the following: 
                ``Notification under this subsection shall include full 
                disclosure of the problems resulting in the shortage, 
                the source of the active pharmaceutical ingredient, 
                associated medical devices used for preparation or 
                administration included in the finished dosage form, 
                any alternative sources for the active pharmaceutical 
                ingredient that are known or contacted by manufacturer, 
                information concerning the extent of the shortage, the 
                expected duration of the shortage, the expected impact 
                to distribution and availability in pharmacies, and 
                such other information as the Secretary may require.''.
    (b) Manufacturing Reporting.--Section 506C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356c) is amended by adding at the end 
the following:
    ``(j) Manufacturer Reporting.--Each manufacturer of a drug 
described in subsection (a) or of any active pharmaceutical ingredient 
or associated medical devices used for preparation or administration 
included in the finished dosage form of such a drug, shall report in 
such manufacturer's annual establishment registration and product 
listing under subsections (b) and (j) of section 510 the specific 
facilities in which such drug or ingredient is manufactured and 
contingency and redundancy plans to help ensure uninterrupted supply of 
the drug or ingredient. Additional manufacturer reporting requirements 
under this section shall be maintained by the Secretary in a 
confidential and internal manner for use by the agency to help ensure 
continued supply of such drugs.''.
    (c) Consumer Notification.--Not later than one year after the date 
of enactment of this Act, the Secretary shall develop and submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives 
legislative and regulatory recommendations for consumer notification in 
the case of a drug shortage, discontinuance, or interruption of the 
manufacture of a drug described in section 506C(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356c(a)), including recommendations 
for notification to patients and physicians, pharmacists, and other 
practitioners authorized under applicable State law to prescribe or 
dispense drugs.
    (d) Reporting After Factory Inspections.--Section 704(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)) is amended--
            (1) by redesignating paragraphs (1) and (2) and 
        subparagraphs (A) and (B);
            (2) by striking ``(b) Upon completion'' and inserting 
        ``(b)(1) Upon completion''; and
            (3) by adding at the end the following:
    ``(2) In carrying out this subsection with respect to any 
establishment manufacturing a drug approved under subsection (c) or (j) 
of section 505 that is described in 506C(a) or 505(j)(11)(A), a copy of 
the report shall be sent promptly to the appropriate offices of the 
Food and Drug Administration with expertise regarding drug shortages. 
Such offices shall ensure timely and effective coordination regarding 
the reviews of such report and overseeing the alignment of any feedback 
regarding such report, or corrective or preventative actions, after 
consideration of the systematic benefits and risks to public health, 
patient safety, the drug supply and drug supply chain, and timely 
patient access to such drugs.''.
    (e) Effective Date.--The amendments made by this section and 
section 2 shall take effect on the date that is 180 days after the date 
of enactment of this Act.

SEC. 4. GAO REPORT ON INTRA-AGENCY COORDINATION.

    (a) In General.--Not later than 18 months after the date of 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives a report examining the Food and Drug Administration's 
intra-agency coordination, communication, and decision making in 
assessing drug shortage risks, and taking corrective action.
    (b) Content.--The report shall include--
            (1) consideration of--
                    (A) risks associated with violations of current 
                good manufacturing practices;
                    (B) corrective and preventative actions with 
                respect to such violations requested by the Food and 
                Drug Administration;
                    (C) the effects of potential manufacturing slow-
                downs or shut-downs on potential drug shortages, 
                including the discontinuance of drug manufacturing and 
                marketing;
                    (D) efforts to prioritize review of applications 
                for drugs that the Secretary has determined under 
                section 506E of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 356e) to be in shortage; and
                    (E) efforts to prioritize inspections of facilities 
                necessary for approval of applications for drugs 
                described in subparagraph (D);
            (2) a description of how the Food and Drug Administration 
        proactively coordinates strategies to mitigate the consequences 
        of the violations, slow-downs, and shut-downs described in 
        paragraph (1) across agencies; and
            (3) an evaluation of changes in relevant Food and Drug 
        Administration practices that such agency has proposed but not 
        yet implemented.

SEC. 5. MODIFICATIONS TO DRUG SHORTAGE LIST MAINTAINED BY FDA.

    (a) In General.--Section 506E of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356e) is amended--
            (1) in subsection (a), by striking the period and inserting 
        the following: ``, by region, including States and localities, 
        where the shortages exist. The Secretary may enter into a 
        private-public partnership to maintain such list.''; and
            (2) in subsection (b)(3)(C), by inserting before the period 
        the following: ``, strength, or dosage form''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
take effect on the date of enactment of this Act, and shall apply to 
updates made to the drug shortage list under section 506E of the 
Federal Food, Drug, and Cosmetic Act after the date of enactment of 
this Act.

SEC. 6. NATIONAL SECURITY RISK ASSESSMENT OF DRUG, ACTIVE 
              PHARMACEUTICAL INGREDIENT AND MEDICAL DEVICE 
              MANUFACTURING OPERATIONS.

    (a) Assessment and Report.--
            (1) In general.--The Secretary of Health and Human 
        Services, in collaboration with the Secretary of Homeland 
        Security and in consultation with stakeholders (including 
        pharmacists, hospitals, physicians, and pharmaceutical and 
        medical device manufacturers), shall conduct a risk assessment 
        of national security threats arising from, or related to, the 
        manufacture and distribution of drugs described in 506C(a) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(a)) or 
        of any active pharmaceutical ingredients of such drugs or 
        associated medical devices used for preparation or 
        administration of such drugs. Not later than 18 months after 
        the date of enactment of this Act, the Secretary shall submit 
        to the Committee on Health, Education, Labor, and Pensions of 
        the Senate and the Committee on Energy and Commerce of the 
        House of Representatives a report outlining findings under such 
        assessment and any recommended actions.
            (2) Content.--The assessment and report under paragraph (1) 
        shall include--
                    (A) a review of manufacturing and distribution of 
                drugs described in such section 506C(a), active 
                pharmaceutical ingredients of such drugs, and 
                associated medical devices used for preparation or 
                administration of such drugs, that includes 
                consideration of whether manufacturing sites and 
                distribution systems should be considered critical 
                infrastructure (as defined in section 1016(e) of the 
                Critical Infrastructures Protection Act of 2001 (42 
                U.S.C. 5195c(e)));
                    (B) a review of risks associated with the foreign 
                manufacture of such drugs, ingredients, or devices; and
                    (C) recommendations on how to mitigate any such 
                risks.
    (b) Standing Forum.--The Secretary of Health and Human Services, in 
collaboration with the Secretary of Homeland Security, shall establish 
a standing forum to engage stakeholders, including pharmacists, 
hospitals, physicians, and pharmaceutical and medical device 
manufacturers, to mitigate risks identified through the assessment 
conducted under subsection (a).
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