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