I 
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. SCHRA-
DER, Mr. MCCAUL, Mr. HUDSON, and Mr. BILIRAKIS) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce 
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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Preventing Drug 
Shortages Act’’. 
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SEC. 2. ADDITIONAL MANUFACTURER REPORTING RE-
QUIREMENTS IN RESPONSE TO SUPPLY DIS-
RUPTIONS. 
(a) EXPANSION
TO
INCLUDE
ACTIVE
PHARMA-
CEUTICAL 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 pharma-
ceutical ingredients’’ before ‘‘that is likely’’; 
(B) ‘‘or its active pharmaceutical ingre-
dient 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 phar-
maceutical ingredient, any alternative sources 
for the active pharmaceutical ingredient that 
are known or contacted by manufacturer, infor-
mation concerning the extent of the supply dis-
ruption, the expected duration of the supply 
disruption, the expected impact to distribution 
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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 manufac-
turer 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 re-
porting under this section shall be maintained by the Sec-
retary in a confidential and internal manner and shall be 
trade secret and/or confidential commercial or financial in-
formation 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 Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate legislative and regulatory recommendations for 
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consumer notification in the case of a drug shortage, dis-
continuance, 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 rec-
ommendations for notification to patients and physicians, 
pharmacists, and other practitioners authorized under ap-
plicable 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 Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report examining the 
Food and Drug Administration’s intra-agency coordina-
tion, 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 cur-
rent good manufacturing practices; 
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(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 applica-
tions for drugs that the Secretary has deter-
mined 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 fa-
cilities 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. 
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SEC. 4. IMPROVING CRITICAL INFRASTRUCTURE BY RE-
QUIRING 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 sub-
section (a) to conduct periodic risk assessments— 
‘‘(1) to identify vulnerabilities in the manufac-
turing supply chain of such manufacturer; and 
‘‘(2) to develop plans to mitigate the risks asso-
ciated 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 guid-
ance shall include guidance on— 
(1) examples of what may be considered a vul-
nerability in the manufacturing supply chain in con-
ducting a risk assessment pursuant to such sub-
section; 
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(2) the timeframe within which a manufacturer 
must conduct such an assessment and provide a re-
sponse 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. 
Æ 
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