Title: Preventing Drug Shortages Act
Policy area: Health

Summary:
Preventing Drug Shortages Act
This bill expands existing manufacturer reporting requirements related to shortages of life-saving drugs and contains other related provisions.
The bill requires a manufacturer of an active pharmaceutical ingredient of a life-saving drug to notify the Food and Drug Administration (FDA) of an interruption that is likely to lead to a meaningful disruption in the ingredient's supply, whereas under current law this requirement generally applies only to the manufacturer of a life-saving drug that faces a supply disruption.
The notification must contain specified information, including any alternative sources for the ingredient.
The bill also requires a manufacturer of a life-saving drug or an active pharmaceutical ingredient for such a drug to include in its annual product registration the specific facilities where the drug or ingredient is manufactured. The FDA may also require the manufacturer to conduct periodic risk assessments to address vulnerabilities in its supply chain.
The Government Accountability Office shall report to Congress on the FDA's intra-agency coordination in assessing drug shortage risks.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6080 Introduced in House (IH)]

<DOC>






116th CONGRESS
  2d Session
                                H. R. 6080

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 4, 2020

    Mr. Peters (for himself, Mr. Engel, Ms. Eshoo, Mr. Guthrie, Mr. 
  Schrader, Mr. McCaul, Mr. Hudson, and Mr. Bilirakis) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 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 ``Preventing Drug Shortages Act''.

SEC. 2. ADDITIONAL MANUFACTURER REPORTING REQUIREMENTS IN RESPONSE TO 
              SUPPLY DISRUPTIONS.

    (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 matter following paragraph (2)--
                    (A) by inserting ``or its active pharmaceutical 
                ingredients'' before ``that is likely'';
                    (B) ``or its active pharmaceutical ingredient or 
                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 supply 
                disruption, the source of the active pharmaceutical 
                ingredient, any alternative sources for the active 
                pharmaceutical ingredient that are known or contacted 
                by manufacturer, information concerning the extent of 
                the supply disruption, the expected duration of the 
                supply disruption, 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 
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 (including the volume manufactured at each such facility) 
to help ensure uninterrupted supply of the drug or ingredient. 
Information obtained through reporting under this section shall be 
maintained by the Secretary in a confidential and internal manner and 
shall be trade secret and/or confidential commercial or financial 
information pursuant to section 552(b)(4) of title 5, United States 
Code.''.
    (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 Energy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pensions of the Senate 
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) Effective Date.--The amendments made by this section shall take 
effect on the date that is 180 days after the date of enactment of this 
Act.

SEC. 3. GAO REPORT ON INTRA-AGENCY COORDINATION.

    (a) In General.--Not later than 18 months after the date of the 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate 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. 4. IMPROVING CRITICAL INFRASTRUCTURE BY REQUIRING RISK MANAGEMENT 
              PLANS.

    (a) Risk Management Plans.--Section 506C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356c), as amended by section 2(b), is 
further amended by adding at the end the following:
    ``(k) Risk Management Plans.--The Secretary may require a 
manufacturer of a drug described in subsection (a) to conduct periodic 
risk assessments--
            ``(1) to identify vulnerabilities in the manufacturing 
        supply chain of such manufacturer; and
            ``(2) to develop plans to mitigate the risks associated 
        with any vulnerabilities so identified.''.
    (b) Guidance.--Not later than 18 months after the date of the 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall finalize 
guidance implementing subsection (l) of section 506C of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection (a). Such guidance 
shall include guidance on--
            (1) examples of what may be considered a vulnerability in 
        the manufacturing supply chain in conducting a risk assessment 
        pursuant to such subsection;
            (2) the timeframe within which a manufacturer must conduct 
        such an assessment and provide a response to the Food and Drug 
        Administration;
            (3) expectations of the Secretary of Health and Human 
        Services for a manufacturer to mitigate in a reasonable manner 
        any risks associated with vulnerabilities in the manufacturing 
        supply chain identified in such an assessment; and
            (4) how the Secretary will coordinate with other Federal 
        agencies to communicate and resolve any such vulnerabilities.
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