I 
112TH CONGRESS 
2D SESSION 
H. R. 3839 
To address critical drug shortages. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 31, 2012 
Mr. CARNEY (for himself and Mr. BUCSHON) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committee on the Judiciary, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To address critical 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 ‘‘Drug Shortage Preven-
tion Act of 2012’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. Actions by Food and Drug Administration To Address Critical Drug 
Shortages. 
Sec. 4. Actions by Attorney General To Address Critical Drug Shortages. 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6211
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
SEC. 3. ACTIONS BY FOOD AND DRUG ADMINISTRATION TO 
ADDRESS CRITICAL DRUG SHORTAGES. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 506C (21 U.S.C. 
356c) the following: 
‘‘SEC. 506D. ADDRESSING CRITICAL DRUG SHORTAGES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) The term ‘biological product’ has the 
meaning given to such term in section 351(i) of the 
Public Health Service Act. 
‘‘(2) The term ‘critical drug’ has the meaning 
given to such term by the Secretary pursuant to 
subsection (b)(2). 
‘‘(3) The term ‘critical drug shortage’ has the 
meaning given to such term by the Secretary pursu-
ant to subsection (c)(2). 
‘‘(4) The term ‘relevant stakeholders’ in-
cludes— 
‘‘(A) with respect to drugs and biological 
products, 
manufacturers, 
distributors, 
and 
group purchasing organizations; and 
‘‘(B) health care providers. 
‘‘(b) NATIONAL CRITICAL DRUG LIST.— 
‘‘(1) LIST.—The Secretary shall— 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(A) not later than 180 days after the date 
of the enactment of this section, establish a list 
identifying each critical drug; 
‘‘(B) promptly remove any drug or biologi-
cal product from such list if the drug or biologi-
cal product no longer meets the definition of a 
critical drug established pursuant to paragraph 
(2); 
‘‘(C) consider for inclusion in such list— 
‘‘(i) each drug and biological product 
that is— 
‘‘(I) approved or licensed under 
section 505 of this Act or section 351 
of the Public Health Service Act; or 
‘‘(II) otherwise marketed pursu-
ant to regulation by the Food and 
Drug Administration; and 
‘‘(ii) each such drug or biological 
product for which a new indication is ap-
proved; 
‘‘(D) include in such list, with respect to 
each listed critical drug, information concerning 
the number and identity of the manufacturers 
of such drug; 
‘‘(E) make such list publicly available; and 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(F) review and update such list semi-
annually. 
‘‘(2) DEFINITION.—Not later than 90 days 
after the date of the enactment of this section, the 
Secretary shall define the term ‘critical drug’ for 
purposes of this section. In defining such term, the 
Secretary shall— 
‘‘(A) solicit input from relevant stake-
holders through a public hearing or an oppor-
tunity to provide written comments; 
‘‘(B) take into account the medical neces-
sity of a drug or biological product and exclude 
any drug or biological product that is not medi-
cally necessary; and 
‘‘(C) take into account the vulnerability of 
a drug or biological product to shortage, includ-
ing because of the number of manufacturers 
and sources of active ingredients involved. 
‘‘(3) REQUEST FOR REMOVAL.— 
‘‘(A) IN GENERAL.—The manufacturer of 
a drug or biological product on the list estab-
lished under paragraph (1) may request that 
the Secretary remove the drug or biological 
product from the list on the basis that the drug 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
or biological product does not satisfy the defini-
tion of a critical drug. 
‘‘(B) ACTION
BY
THE
SECRETARY.—Not 
later than 45 days after receipt of such a re-
quest, the Secretary shall review the determina-
tion that the drug or biological product is a 
critical drug and— 
‘‘(i) remove the drug or biological 
product from the list established under 
paragraph (1) if the Secretary determines 
that the drug is not a critical drug; or 
‘‘(ii) provide to the manufacturer sub-
mitting such request an explanation of why 
the drug or biological product was properly 
determined to be a critical drug. 
‘‘(c) NATIONAL CRITICAL DRUG SHORTAGE LIST.— 
‘‘(1) LIST.—The Secretary shall— 
‘‘(A) not later than 1 year after the date 
of the enactment of this section, establish and 
make publicly available a list identifying each 
critical drug that is in a critical drug shortage; 
and 
‘‘(B) not less than monthly, review and, as 
appropriate, update such list. 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(2) DEFINITION.—Not later than 180 days 
after the date of the enactment of this section, the 
Secretary shall define the term ‘critical drug short-
age’ for purposes of this section. In defining such 
term, the Secretary shall— 
‘‘(A) solicit input from relevant stake-
holders through a public hearing or an oppor-
tunity to provide written comments; and 
‘‘(B) limit the definition to actual short-
ages in the United States of critical drugs. 
‘‘(3) CONTENTS.—The list established under 
paragraph (1) shall, with respect to each listed crit-
ical drug shortage, include at a minimum access to 
the following information: 
‘‘(A) Indication of the severity of the 
shortage. 
‘‘(B) Each reason for the shortage. 
‘‘(C) An estimated date by which the crit-
ical drug involved will begin reaching providers 
in quantities sufficient to meet demand. 
‘‘(D) Identification of alternate therapies. 
‘‘(E) Identification of specific regions of 
the country particularly affected or specifically 
not affected by the shortage. 
‘‘(4) REQUEST FOR REMOVAL.— 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(B) SYSTEM REQUIREMENTS.—The sys-
tem under subparagraph (A) shall provide such 
notices— 
‘‘(i) to any member of the public on 
an opt-in basis; and 
‘‘(ii) in written form comprehensible 
to a lay reader. 
‘‘(C) 
INITIAL
IMPLEMENTATION.—The 
Secretary shall begin implementation of the sys-
tem under subparagraph (A) not later than 1 
year after the date of the enactment of this sec-
tion. 
‘‘(2) NOTIFICATIONS TO MANUFACTURERS AND 
DISTRIBUTORS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish and implement a system for giving no-
tice of any imminent critical drug shortage to— 
‘‘(i) any manufacturer of the critical 
drug registered under section 510; 
‘‘(ii) any manufacturer so registered 
with capacity to manufacture the critical 
drug or an alternate therapy to the critical 
drug; and 
‘‘(iii) subject to subparagraph (B) and 
at the Secretary’s discretion, any wholesale 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
distributor of the critical drug that has a 
contractual relationship with— 
‘‘(I) the manufacturer of the crit-
ical drug; or 
‘‘(II) an authorized distributor of 
record (as such term is defined in sec-
tion 503(e)(3)) of the critical drug. 
‘‘(B) WHOLESALE DISTRIBUTORS PARTICI-
PATING IN UNLAWFUL ACTIVITIES.—If the At-
torney General determines that a wholesale dis-
tributor of a critical drug is participating in 
stockpiling, price gouging, or other unlawful ac-
tivities related to the distribution of a critical 
drug, the Secretary shall withhold any notifica-
tion that would otherwise be made to the dis-
tributor under subparagraph (A) with respect 
to the critical drug until the Attorney General 
determines that the distributor is no longer par-
ticipating in such activities. 
‘‘(C) 
INITIAL
IMPLEMENTATION.—The 
Secretary shall begin implementation of the sys-
tem under subparagraph (A) not later than 180 
days after the date of the enactment of this sec-
tion. 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(3) 
NOTIFICATIONS
TO
ATTORNEY
GEN-
ERAL.—The Secretary shall— 
‘‘(A) give notice to the Attorney General of 
any critical drug shortage listed under sub-
section (c); and 
‘‘(B) provide such information to the At-
torney General as may be necessary to deter-
mine the extent to which it is appropriate to in-
crease one or more production quotas under 
section 306(h) of the Controlled Substances Act 
in order to address such shortage. 
‘‘(e) STUDY ON FEASIBILITY OF NATIONAL CONTIN-
GENCY PLAN.— 
‘‘(1) STUDY.—The Secretary shall conduct a 
study on the feasibility of creating a national contin-
gency plan addressing critical drug shortages, in-
cluding with respect to— 
‘‘(A) the creation of a Federal stockpile of 
critical drugs for the purpose of responding to 
potential critical drug shortages; or 
‘‘(B) the expansion of an existing Federal 
stockpile of drugs to include critical drugs for 
such purpose. 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(2) CONSULTATION.—In conducting the study 
under paragraph (1), the Secretary shall consult 
with relevant stakeholders. 
‘‘(3) REPORT.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary 
shall complete the study required by paragraph (1) 
and submit to the Congress a report on the results 
of such study. 
‘‘(f) APPROVAL OF DRUGS.— 
‘‘(1) EXPEDITED REVIEW.—The Secretary shall 
expedite the review of— 
‘‘(A) any application seeking approval of a 
critical drug under subsection (c) or (j) of sec-
tion 505 of this Act or licensing of a critical 
drug under section 351 of the Public Health 
Service Act; and 
‘‘(B) any request by the sponsor of a crit-
ical drug to approve— 
‘‘(i) a change to the manufacturing 
process for a critical drug, including any 
change in the facilities used for such proc-
ess; or 
‘‘(ii) an alternate supplier of any ac-
tive ingredient in a critical drug. 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(2) NO DELAY OF OTHER APPLICATIONS.—In 
expediting the review of applications and requests 
under paragraph (1), the Secretary shall not unnec-
essarily delay the review of applications and requests 
for drugs and biological products that are not crit-
ical drugs. 
‘‘(3) ESTABLISHMENT
OF
PROCEDURES
AND 
TIMEFRAMES.—Not later than 90 days after the 
date of the enactment of this section, the Secretary, 
with input from relevant stakeholders, shall establish 
procedures and timeframes for providing expedited 
review under paragraph (1). 
‘‘(g) IMPROVED REGULATION.—The Secretary shall 
review and improve the process for regulating critical 
drugs so as to— 
‘‘(1) ensure that, at each stage of such process, 
the status of such drugs as critical drugs is taken 
into consideration; 
‘‘(2) improve communications between the of-
fices and officials of the Food and Drug Administra-
tion responsible for approving and regulating critical 
drugs and the offices and officials of the Food and 
Drug Administration responsible for identifying and 
addressing critical drug shortages; and 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(3) ensure that any new regulatory concern 
about a critical drug identified by Food and Drug 
Administration personnel is communicated— 
‘‘(A) within 1 business day to the office of 
the Food and Drug Administration responsible 
for identifying and addressing critical drug 
shortages; and 
‘‘(B) within 5 business days to the manu-
facturer of the critical drug. 
‘‘(h) CONFIDENTIALITY.— 
‘‘(1) IN
GENERAL.—Except as described in 
paragraph (2), in carrying out this section, the Sec-
retary shall not disclose— 
‘‘(A) any trade secret or other matter that 
is referred to in section 1905 of title 18 of the 
United States Code, or 
‘‘(B) any trade secret or other commercial 
or financial information that is exempt from 
disclosure under section 552(b)(4) of title 5 of 
the United States Code. 
‘‘(2) DISCLOSURE TO FEDERAL OFFICERS AND 
EMPLOYEES.—The Secretary may disclose such mat-
ter or information to an officer or employee of the 
Federal Government, but only if— 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(A) such disclosure is for the purpose of 
carrying out this section or section 306(h) of 
the Controlled Substances Act; and 
‘‘(B) any further disclosure of such matter 
or information by the officer and employee is 
restricted to the same extent as disclosure of 
such matter or information by the Secretary. 
‘‘(i) SENSE OF CONGRESS REGARDING INCREASE IN 
PERSONNEL.—It is the sense of the Congress that the 
Food and Drug Administration should increase the num-
ber of personnel responsible for identifying and addressing 
critical drug shortages.’’. 
SEC. 4. ACTIONS BY ATTORNEY GENERAL TO ADDRESS 
CRITICAL DRUG SHORTAGES. 
Section 306 of the Controlled Substances Act (21 
U.S.C. 826) is amended by adding at the end the fol-
lowing: 
‘‘(h) If the Secretary of Health and Human Services 
lists a critical drug shortage under section 506D(c) of the 
Federal Food, Drug, and Cosmetic Act, and the drug in-
volved or any ingredient therein is a controlled substance 
subject to a quota under this section, then the Attorney 
General shall increase such quota to the extent determined 
by the Attorney General, in consultation with the Sec-
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS
retary of Health and Human Services, to be appropriate 
to address the critical drug shortage.’’. 
Æ 
VerDate Mar 15 2010 
03:57 Feb 01, 2012
Jkt 019200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6301
E:\BILLS\H3839.IH
H3839
smartinez on DSK6TPTVN1PROD with BILLS