I 
112TH CONGRESS 
1ST SESSION H. R. 2245 
To amend the Federal Food, Drug, and Cosmetic Act to provide the Food 
and Drug Administration with improved capacity to prevent drug shortages. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 21, 2011 
Ms. DEGETTE (for herself and Mr. ROONEY) 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 
provide the Food and Drug Administration with im-
proved capacity to prevent drug shortages. 
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 ‘‘Preserving Access to 
Life-Saving Medications Act of 2011’’. 
SEC. 2. DISCONTINUANCE OR INTERRUPTION OF THE MAN-
UFACTURE OF A PRESCRIPTION DRUG. 
(a) IN GENERAL.—Section 506C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amend-
ed to read as follows: 
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‘‘SEC. 506C. DISCONTINUANCE OR INTERRUPTION OF THE 
MANUFACTURE OF A PRESCRIPTION DRUG. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) The term ‘average historic demand’ means 
the individual manufacturer’s average monthly vol-
ume of sales of the drug during the last calendar 
year. 
‘‘(2) The term ‘discontinuance’ means the per-
manent termination of the manufacture of a drug by 
an individual manufacturer. 
‘‘(3) The term ‘interruption’ means a change 
that— 
‘‘(A) may result in the total supply of a 
drug manufactured by the individual manufac-
turer not meeting average historic demand; and 
‘‘(B) consists of— 
‘‘(i) a change in the supply of one or 
more raw materials, including active phar-
maceutical ingredients; 
‘‘(ii) an unplanned interruption in 
ability to produce the drug; 
‘‘(iii) a business decision affecting the 
manufacture of the drug, such as a merger 
or a change in production output; or 
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‘‘(iv) any other type change that could 
have the result described in subparagraph 
(A), as determined by the Secretary. 
‘‘(b) NOTIFICATIONS BY MANUFACTURERS.— 
‘‘(1) IN GENERAL.—A manufacturer of a drug 
that is subject to section 503(b)(1) and marketed in 
interstate commerce shall notify the Secretary of a 
discontinuance or interruption in the manufacture of 
such drug. 
‘‘(2) NOTIFICATION
PERIOD.—A notification 
pursuant to paragraph (1) shall be submitted to the 
Secretary— 
‘‘(A) in the case of a planned discontinu-
ance, at least 6 months prior to the date of 
such discontinuance; and 
‘‘(B) in the case of any other discontinu-
ance or interruption— 
‘‘(i) at least 6 months prior to the 
date of such discontinuance or interrup-
tion; or 
‘‘(ii) if the manufacturer cannot pro-
vide 6 months advance notice, as soon as 
practicable after the manufacturer— 
‘‘(I) becomes aware of such dis-
continuance; or 
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‘‘(II) becomes aware that such 
interruption may result in the total 
supply of the drug manufactured by 
the individual manufacturer not meet-
ing average historic demand. 
‘‘(3) ADDITIONAL INFORMATION.—A manufac-
turer may, but is not required to, include in a notifi-
cation submitted pursuant to paragraph (1) infor-
mation about an alternative source of the drug or 
the availability of a drug with the same active ingre-
dient. 
‘‘(4) REDUCTION IN NOTIFICATION PERIOD.— 
The notification period required under paragraph 
(2) for a manufacturer may be reduced if the manu-
facturer certifies to the Secretary that good cause 
exists for the reduction, such as a situation in 
which— 
‘‘(A) a public health problem may result 
from continuation of the manufacturing for the 
6-month period; 
‘‘(B) a biomaterials shortage prevents the 
continuation of the manufacturing for the 6- 
month period; 
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‘‘(C) a liability problem may exist for the 
manufacturer if the manufacturing is continued 
for the 6-month period; 
‘‘(D) continuation of the manufacturing 
for the 6-month period may cause substantial 
economic hardship for the manufacturer; 
‘‘(E) the manufacturer has filed for bank-
ruptcy under chapter 7 or 11 of title 11, United 
States Code; or 
‘‘(F) the manufacturer can continue the 
distribution of the drug involved for 6 months. 
‘‘(5) OTHER REDUCTIONS IN NOTIFICATION PE-
RIOD.—The Secretary may reduce the notification 
period required under paragraph (2) based on— 
‘‘(A) the type of discontinuance or inter-
ruption at issue; and 
‘‘(B) any other factor, as determined by 
the Secretary. 
‘‘(6) CONFIDENTIALITY
OF
INFORMATION.— 
Any information provided to the Secretary under 
paragraph (1) shall be treated as trade secret or 
confidential information subject to section 552(b)(4) 
of title 5 and section 1905 of title 18. 
‘‘(7) ENFORCEMENT.— 
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‘‘(A) Any manufacturer that knowingly 
fails to submit a notification in violation of 
paragraph (1) shall be subject to a civil money 
penalty not to exceed $10,000 for each day on 
which the violation continues, and not to exceed 
$1,800,000 for all such violations adjudicated 
in a single proceeding. 
‘‘(B) Not later than 180 days after the 
date of the enactment of the Preserving Access 
to Life-Saving Medications Act of 2011, the 
Secretary shall, subject to subparagraph (A), 
promulgate final regulations establishing a 
schedule of civil monetary penalties for viola-
tions of paragraph (1). 
‘‘(C) The provisions of paragraphs (5), (6), 
and (7) of section 303(f) shall apply with re-
spect to a civil penalty under this paragraph to 
the same extent and in the same manner as 
such provisions apply with respect to a civil 
penalty under paragraph (1), (2), (3), (4), or 
(9) of section 303(f). 
‘‘(c) NOTIFICATIONS BY SECRETARY.— 
‘‘(1) DRUG SHORTAGE DEFINED.—In this sec-
tion, the term ‘drug shortage’ means, with respect to 
a drug, a period of time when the total supply of 
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such drug available at the user level will not meet 
the demand for such drug at the user level as deter-
mined by the Secretary. 
‘‘(2) PUBLIC NOTIFICATION.— 
‘‘(A) IN GENERAL.—Subject to subsection 
(b)(6), the Secretary shall— 
‘‘(i) publish on the public Internet 
Web site of the Food and Drug Adminis-
tration information on— 
‘‘(I) the types of discontinuances 
and interruptions for which a notifica-
tion is required under subsection 
(b)(1); and 
‘‘(II) actual drug shortages; and 
‘‘(ii) to the maximum extent prac-
ticable, distribute such information to ap-
propriate health care providers and patient 
organizations. 
‘‘(B) DURATION.—The Secretary shall in-
clude in any publication or distribution under 
subparagraph (A), when possible, an estimate 
of the expected duration of any discontinuance 
or interruption or actual drug shortage. 
‘‘(3) IDENTIFICATION
AND
NOTIFICATION
OF 
DRUGS VULNERABLE TO DRUG SHORTAGE.— 
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‘‘(A) IN GENERAL.—If the Secretary deter-
mines using the criteria under subparagraph 
(B) that a drug may be vulnerable to a drug 
shortage, the Secretary shall notify the manu-
facturer of the drug of— 
‘‘(i) such determination; and 
‘‘(ii) the Secretary’s duty to collabo-
rate to improve continuity of supply plans 
under paragraph (4). 
‘‘(B) EVIDENCE-BASED
CRITERIA.—The 
Secretary shall implement evidence-based cri-
teria for identifying drugs that may be vulner-
able to a drug shortage. Such criteria shall be 
based on— 
‘‘(i) the number of manufacturers of 
the drug; 
‘‘(ii) the sources of raw material or 
active pharmaceutical ingredients; 
‘‘(iii) the supply chain characteristics, 
such as production complexities; and 
‘‘(iv) the availability of therapeutic al-
ternatives. 
‘‘(4) CONTINUITY OF SUPPLY PLANS.— 
‘‘(A) IN GENERAL.—With respect to drugs 
that are vulnerable to a drug shortage (as de-
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termined under paragraph (3)), the Secretary 
shall collaborate with manufacturers and other 
stakeholders (such as distributors and health 
care providers) to establish and improve con-
tinuity of supply plans, so that such plans in-
clude a process for addressing drug shortages. 
‘‘(B) LIMITATION
ON
SECRETARY’S
AU-
THORITY.—The Secretary may not in any case 
require a manufacturer— 
‘‘(i) to manufacture a drug in the 
event of a discontinuance or interruption; 
or 
‘‘(ii) to delay or alter a discontinuance 
or interruption. 
‘‘(C) ALLOCATION BY MANUFACTURER.— 
No provision of Federal law shall be construed 
to prohibit a manufacturer from, or penalize a 
manufacturer for, allocating distribution of its 
products in order to manage an actual or poten-
tial drug shortage. 
‘‘(d) RULEMAKING.—The Secretary shall carry out 
this section pursuant to regulations promulgated after 
providing notice and an opportunity for comment.’’. 
(b) APPLICABILITY; TRANSITIONAL PERIOD.—Sec-
tion 506C of the Federal Food, Drug, and Cosmetic Act, 
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as amended by subsection (a), applies with respect to 
discontinuances, interruptions, and drug shortages (as 
such terms are used in such section 506C) that occur on 
or after the day that is 1 year after the date of the enact-
ment of this Act. Until such day, the provisions of section 
506C of the Federal Food, Drug, and Cosmetic Act, as 
in effect on the day before the enactment of this Act, shall 
continue to apply. 
SEC. 3. REPORTS TO CONGRESS. 
The Secretary of Health and Human Services shall 
submit to the Congress— 
(1) not later than the date that is 1 year after 
the date of the enactment of this Act, a report de-
scribing the actions taken by the Secretary during 
the previous 1-year period to address drug shortages 
(as defined in section 506C of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 2) 
through all aspects of the prescription drug supply 
chain; and 
(2) every 5 years thereafter, a report describing 
such actions taken by the Secretary during the pre-
vious 5-year period. 
SEC. 4. GAO STUDY. 
(a) STUDY.—The Comptroller General of the United 
States shall conduct a study— 
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(1) to examine how the Food and Drug Admin-
istration identifies and responds to drug shortages 
(as defined in section 506C of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 2); 
(2) to examine the possible causes of such drug 
shortages, including manufacturing problems, break-
down in the supply chain delivery system, changes in 
the supply of raw materials, stockpiling at the 
wholesale or provider level, and restrictive regulatory 
requirements; 
(3) to identify if there is adequate communica-
tion between industry, the Food and Drug Adminis-
tration, distributors, and end users; 
(4) to analyze the effects of the enactment of 
this Act on the ability of the Food and Drug Admin-
istration to identify and ameliorate such drug short-
ages; and 
(5) to identify any additional measures that 
need to be taken to prevent or address such drug 
shortages. 
(b) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Comptroller General shall 
submit a report to the Congress on the results of the study 
under subsection (a). 
Æ 
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