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(1) in the subsection heading by inserting ‘‘AND 
MODIFICATIONS’’ 
after 
‘‘REVIEW
OF
ASSESS-
MENTS’’; 
(2) in paragraph (1)— 
(A) by inserting ‘‘and proposed modifica-
tion to’’ after ‘‘under subsection (a) and each 
assessment of’’; and 
(B) by inserting ‘‘, and, if necessary, 
promptly initiate discussions with the respon-
sible person about such proposed strategy, as-
sessment, or modification’’ after ‘‘subsection 
(g)’’; 
(3) by striking paragraph (2); 
(4) by redesignating paragraphs (3) through 
(9) as paragraphs (2) through (8), respectively; 
(5) in paragraph (2), as redesignated by para-
graph (4)— 
(A) by amending subparagraph (A) to read 
as follows: 
‘‘(A) IN GENERAL.— 
‘‘(i) TIMEFRAME.—Unless the dispute 
resolution process described under para-
graph (3) or (4) applies, and, except as 
provided in clause (ii) or clause (iii) below, 
the Secretary, in consultation with the of-
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fices described in subsection (c)(2), shall 
review and act on the proposed risk evalua-
tion and mitigation strategy for a drug or 
any proposed modification to any required 
strategy within 180 days of receipt of the 
proposed strategy or modification. 
‘‘(ii) MINOR
MODIFICATIONS.—The 
Secretary shall review and act on a pro-
posed minor modification, as defined by 
the Secretary in guidance, within 60 days 
of receipt of such modification. 
‘‘(iii) REMS MODIFICATION DUE TO 
SAFETY LABEL CHANGES.—Not later than 
60 days after the Secretary receives a pro-
posed modification to an approved risk 
evaluation and mitigation strategy to con-
form the strategy to approved safety label 
changes, including safety labeling changes 
initiated by the sponsor in accordance with 
FDA regulatory requirements, or to a safe-
ty label change that the Secretary has di-
rected the holder of the application to 
make pursuant to section 505(o)(4), the 
Secretary shall review and act on such pro-
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posed modification to the approved strat-
egy. 
‘‘(iv) GUIDANCE.—The Secretary shall 
establish, through guidance, that respon-
sible persons may implement certain modi-
fications to an approved risk evaluation 
and mitigation strategy following notifica-
tion to the Secretary.’’; and 
(B) by amending subparagraph (C) to read 
as follows: 
‘‘(C) PUBLIC AVAILABILITY.—Upon acting 
on a proposed risk evaluation and mitigation 
strategy or proposed modification to a risk eval-
uation and mitigation strategy under subpara-
graph (A), the Secretary shall make publicly 
available an action letter describing the actions 
taken by the Secretary under such subpara-
graph (A).’’. 
(6) in paragraph (4), as redesignated by para-
graph (4)— 
(A) in subparagraph (A)(i)— 
(i) by striking ‘‘Not earlier than 15 
days, and not later than 35 days, after dis-
cussions under paragraph (2) have begun, 
the’’ and inserting ‘‘The’’; and 
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(ii) by inserting ‘‘, after the sponsor is 
required to make a submission under sub-
section (a)(2) or (g),’’ before ‘‘request in 
writing’’; and 
(B) in subparagraph (I)— 
(i) by striking clauses (i) and (ii); and 
(ii) by striking ‘‘if the Secretary—’’ 
and inserting ‘‘if the Secretary has com-
plied with the timing requirements of 
scheduling review by the Drug Safety 
Oversight Board, providing a written rec-
ommendation, and issuing an action letter 
under subparagraphs (B), (F), and (G), 
respectively.’’; 
(7) in paragraph (5), as redesignated by para-
graph (4)— 
(A) in subparagraph (A), by striking ‘‘any 
of subparagraphs (B) through (D)’’ and insert-
ing ‘‘subparagraph (B) or (C)’’; and 
(B) in subparagraph (C), by striking 
‘‘paragraph (4) or (5)’’ and inserting ‘‘para-
graph (3) or (4)’’; and 
(8) in paragraph (8), as redesignated by para-
graph (4), by striking ‘‘paragraphs (7) and (8)’’ and 
inserting ‘‘paragraphs (6) and (7).’’. 
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(c) GUIDANCE.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and 
Human Services shall issue guidance that, for purposes 
of section 505–1(h)(2)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1(h)(2)(A)), describes the 
types of modifications to approved risk evaluation and 
mitigation strategies that shall be considered to be minor 
modifications of such strategies. 
SEC. 868. CONSULTATION WITH EXTERNAL EXPERTS ON 
RARE DISEASES, TARGETED THERAPIES, AND 
GENETIC TARGETING OF TREATMENTS. 
Subchapter E of chapter V (21 U.S.C. 360bbb et 
seq.), as amended by section 811(b), is further amended 
by adding at the end the following: 
‘‘SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON 
RARE DISEASES, TARGETED THERAPIES, AND 
GENETIC TARGETING OF TREATMENTS. 
‘‘(a) IN GENERAL.—For the purpose of promoting 
the efficiency of and informing the review by the Food 
and Drug Administration of new drugs and biological 
products for rare diseases and drugs and biological prod-
ucts that are genetically targeted, the following shall 
apply: 
‘‘(1) CONSULTATION WITH STAKEHOLDERS.— 
Consistent with sections X.C and IX.E.4 of the 
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PDUFA Reauthorization Performance Goals and 
Procedures Fiscal Years 2013 through 2017, as ref-
erenced in the letters described in section 101(b) of 
the Prescription Drug User Fee Amendments of 
2012, the Secretary shall ensure that opportunities 
exist, at a time the Secretary determines appro-
priate, for consultations with stakeholders on the 
topics described in subsection (b). 
‘‘(2) CONSULTATION
WITH
EXTERNAL
EX-
PERTS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
develop and maintain a list of external experts 
who, because of their special expertise, are 
qualified to provide advice on rare disease 
issues, including topics described in subsection 
(c). The Secretary may, when appropriate to 
address a specific regulatory question, consult 
such external experts on issues related to the 
review of new drugs and biological products for 
rare diseases and drugs and biological products 
that are genetically targeted, including the top-
ics described in subsection (b), when such con-
sultation is necessary because the Secretary 
lacks the specific scientific, medical, or tech-
nical expertise necessary for the performance of 
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the Secretary’s regulatory responsibilities and 
the necessary expertise can be provided by the 
external experts. 
‘‘(B) EXTERNAL EXPERTS.—For purposes 
of subparagraph (A), external experts are indi-
viduals who possess scientific or medical train-
ing that the Secretary lacks with respect to one 
or more rare diseases. 
‘‘(b) TOPICS FOR CONSULTATION.—Topics for con-
sultation pursuant to this section may include— 
‘‘(1) rare diseases; 
‘‘(2) the severity of rare diseases; 
‘‘(3) the unmet medical need associated with 
rare diseases; 
‘‘(4) the willingness and ability of individuals 
with a rare disease to participate in clinical trials; 
‘‘(5) an assessment of the benefits and risks of 
therapies to treat rare diseases; 
‘‘(6) the general design of clinical trials for rare 
disease populations and subpopulations; and 
‘‘(7) the demographics and the clinical descrip-
tion of patient populations. 
‘‘(c) CLASSIFICATION AS SPECIAL GOVERNMENT EM-
PLOYEES.—The external experts who are consulted under 
this section may be considered special government employ-
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ees, as defined under section 202 of title 18, United States 
Code. 
‘‘(d) PROTECTION OF CONFIDENTIAL INFORMATION 
AND TRADE SECRETS.— 
‘‘(1) RULE
OF
CONSTRUCTION.—Nothing in 
this section shall be construed to alter the protec-
tions offered by laws, regulations, and policies gov-
erning disclosure of confidential commercial or trade 
secret information, and any other information ex-
empt from disclosure pursuant to section 552(b) of 
title 5, United States Code, as such provisions would 
be applied to consultation with individuals and orga-
nizations prior to the date of enactment of this sec-
tion. 
‘‘(2) CONSENT REQUIRED FOR DISCLOSURE.— 
The Secretary shall not disclose confidential com-
mercial or trade secret information to an expert con-
sulted under this section without the written consent 
of the sponsor unless the expert is a special govern-
ment employee (as defined under section 202 of title 
18, United States Code) or the disclosure is other-
wise authorized by law. 
‘‘(e) OTHER CONSULTATION.—Nothing in this sec-
tion shall be construed to limit the ability of the Secretary 
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to consult with individuals and organizations as authorized 
prior to the date of enactment of this section. 
‘‘(f) NO RIGHT OR OBLIGATION.— 
‘‘(1) NO RIGHT TO CONSULTATION.—Nothing 
in this section shall be construed to create a legal 
right for a consultation on any matter or require the 
Secretary to meet with any particular expert or 
stakeholder. 
‘‘(2) NO ALTERING OF GOALS.—Nothing in this 
section shall be construed to alter agreed upon goals 
and procedures identified in the letters described in 
section 101(b) of the Prescription Drug User Fee 
Amendments of 2012. 
‘‘(3) NO CHANGE TO NUMBER OF REVIEW CY-
CLES.—Nothing in this section is intended to in-
crease the number of review cycles as in effect before 
the date of enactment of this section. 
‘‘(g) NO DELAY IN PRODUCT REVIEW.—Prior to a 
consultation with an external expert, as described in this 
section, relating to an investigational new drug application 
under section 505(i), a new drug application under section 
505(b), or a biologics license application under section 351 
of the Public Health Service Act, the Director of the Cen-
ter for Drug Evaluation and Research or the Director of 
the Center for Biologics Evaluation and Research (or ap-
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propriate Division Director), as appropriate, shall deter-
mine that— 
‘‘(1) such consultation will— 
‘‘(A) facilitate the Secretary’s ability to 
complete the Secretary’s review; 
‘‘(B) address outstanding deficiencies in 
the application; and 
‘‘(C) increase the likelihood of an approval 
decision in the current review cycle; or 
‘‘(2) the sponsor authorized such consultation.’’. 
SEC. 869. BREAKTHROUGH THERAPIES. 
(a) IN GENERAL.—Section 506 (21 U.S.C. 356), as 
amended by section 841, is further amended— 
(1) by redesignating subsection (d) as sub-
section (e); 
(2) by redesignating subsections (a) through (c) 
as subsections (b) through (d), respectively; 
(3) by inserting before subsection (b), as so re-
designated, the following: 
‘‘(a) DESIGNATION OF A DRUG AS A BREAKTHROUGH 
THERAPY.— 
‘‘(1) IN GENERAL.—The Secretary shall, at the 
request of the sponsor of a drug, expedite the devel-
opment and review of such drug if the drug is in-
tended, alone or in combination with 1 or more other 
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drugs, to treat a serious or life-threatening disease 
or condition and preliminary clinical evidence indi-
cates that the drug may demonstrate substantial im-
provement over existing therapies on 1 or more clini-
cally significant endpoints, such as substantial treat-
ment effects observed early in clinical development. 
In this section, such a drug is referred to as a 
‘breakthrough therapy’. 
‘‘(2) REQUEST FOR DESIGNATION.—The spon-
sor of a drug may request the Secretary to designate 
the drug as a breakthrough therapy. A request for 
the designation may be made concurrently with, or 
at any time after, the submission of an application 
for the investigation of the drug under section 505(i) 
or section 351(a)(3) of the Public Health Service 
Act. 
‘‘(3) DESIGNATION.— 
‘‘(A) IN GENERAL.—Not later than 60 cal-
endar days after the receipt of a request under 
paragraph (2), the Secretary shall determine 
whether the drug that is the subject of the re-
quest meets the criteria described in paragraph 
(1). If the Secretary finds that the drug meets 
the criteria, the Secretary shall designate the 
drug as a breakthrough therapy and shall take 
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such actions as are appropriate to expedite the 
development and review of the application for 
approval of such drug. 
‘‘(B) ACTIONS.—The actions to expedite 
the development and review of an application 
under subparagraph (A) may include, as appro-
priate— 
‘‘(i) holding meetings with the sponsor 
and the review team throughout the devel-
opment of the drug; 
‘‘(ii) providing timely advice to, and 
interactive communication with, the spon-
sor regarding the development of the drug 
to ensure that the development program to 
gather the non-clinical and clinical data 
necessary for approval is as efficient as 
practicable; 
‘‘(iii) involving senior managers and 
experienced review staff, as appropriate, in 
a collaborative, cross-disciplinary review; 
‘‘(iv) assigning a cross-disciplinary 
project lead for the Food and Drug Ad-
ministration review team to facilitate an 
efficient review of the development pro-
gram and to serve as a scientific liaison be-
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tween the review team and the sponsor; 
and 
‘‘(v) taking steps to ensure that the 
design of the clinical trials is as efficient as 
practicable, when scientifically appropriate, 
such as by minimizing the number of pa-
tients exposed to a potentially less effica-
cious treatment.’’; 
(4) in subsection (e)(1), as so redesignated, by 
striking ‘‘applicable to accelerated approval’’ and in-
serting ‘‘applicable to breakthrough therapies, accel-
erated approval,’’; and 
(5) by adding at the end the following: 
‘‘(f) REPORT.—Beginning in fiscal year 2013, the 
Secretary shall annually prepare and submit to the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of 
the House of Representatives, and make publicly available, 
with respect to this section for the previous fiscal year— 
‘‘(1) the number of drugs for which a sponsor 
requested designation as a breakthrough therapy; 
‘‘(2) the number of products designated as a 
breakthrough therapy; and 
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‘‘(3) for each product designated as a break-
through therapy, a summary of the actions taken 
under subsection (a)(3).’’. 
(b) GUIDANCE; AMENDED REGULATIONS.— 
(1) IN GENERAL.— 
(A) 
GUIDANCE.—Not 
later 
than 
months after the date of enactment of this Act, 
the Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’) 
shall issue draft guidance on implementing the 
requirements with respect to breakthrough 
therapies, as set forth in section 506(a) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 356(a)), as amended by this section. 
The Secretary shall issue final guidance not 
later than 1 year after the close of the comment 
period for the draft guidance. 
(B) AMENDED REGULATIONS.— 
(i) IN GENERAL.—If the Secretary de-
termines that it is necessary to amend the 
regulations under title 21, Code of Federal 
Regulations in order to implement the 
amendments made by this section to sec-
tion 506(a) of the Federal Food, Drug, 
and Cosmetic Act, the Secretary shall 
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amend such regulations not later than 2 
years after the date of enactment of this 
Act. 
(ii) PROCEDURE.—In amending regu-
lations under clause (i), the Secretary 
shall— 
(I) issue a notice of proposed 
rulemaking that includes the proposed 
regulation; 
(II) provide a period of not less 
than 60 days for comments on the 
proposed regulation; and 
(III) publish the final regulation 
not less than 30 days before the effec-
tive date of the regulation. 
(iii) RESTRICTIONS.—Notwithstanding 
any other provision of law, the Secretary 
shall promulgate regulations implementing 
the amendments made by section only as 
described in clause (ii). 
(2) REQUIREMENTS.—Guidance issued under 
this section shall— 
(A) specify the process and criteria by 
which the Secretary makes a designation under 
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section 506(a)(3) of the Federal Food, Drug, 
and Cosmetic Act; and 
(B) specify the actions the Secretary shall 
take to expedite the development and review of 
a breakthrough therapy pursuant to such des-
ignation under such section 506(a)(3), includ-
ing updating good review management practices 
to reflect breakthrough therapies. 
(c) INDEPENDENT REVIEW.—Not later than 3 years 
after the date of enactment of this Act, the Comptroller 
General of the United States, in consultation with appro-
priate experts, shall assess the manner by which the Food 
and Drug Administration has applied the processes de-
scribed in section 506(a) of the Federal Food, Drug, and 
Cosmetic Act, as amended by this section, and the impact 
of such processes on the development and timely avail-
ability of innovative treatments for patients affected by se-
rious or life-threatening conditions. Such assessment shall 
be made publicly available upon completion. 
(d) CONFORMING AMENDMENTS.—Section 506B(e) 
(21 U.S.C. 356b) is amended by striking ‘‘section 
506(b)(2)(A)’’ each place such term appears and inserting 
‘‘section 506(c)(2)(A)’’. 
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SEC. 870. GRANTS AND CONTRACTS FOR THE DEVELOP-
MENT OF ORPHAN DRUGS. 
(a) QUALIFIED
TESTING
DEFINITION.—Section 
5(b)(1)(A)(ii) of the Orphan Drug Act (21 U.S.C. 
360ee(b)(1)(A)(ii)) is amended by striking ‘‘after the date 
such drug is designated under section 526 of such Act 
and’’. 
(b) AUTHORIZATION OF APPROPRIATIONS.—Section 
5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is 
amended to read as follows: 
‘‘(c) AUTHORIZATION
OF
APPROPRIATIONS.—For 
grants and contracts under subsection (a), there is author-
ized to be appropriated $30,000,000 for each of fiscal 
years 2013 through 2017.’’. 
TITLE IX—DRUG SHORTAGES 
SEC. 901. DISCONTINUANCE AND INTERRUPTIONS OF MAN-
UFACTURING OF CERTAIN DRUGS. 
(a) IN GENERAL.—Section 506C (21 U.S.C. 356c) 
is amended to read as follows: 
‘‘SEC. 506C. DISCONTINUANCE AND INTERRUPTIONS OF 
MANUFACTURING OF CERTAIN DRUGS. 
‘‘(a) IN GENERAL.—A manufacturer of a drug sub-
ject to section 503(b)(1)— 
‘‘(1) that is— 
‘‘(A) life-supporting; 
‘‘(B) life-sustaining; or 
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‘‘(C) intended for use in the prevention or 
treatment of a debilitating disease or condition; 
and 
‘‘(2) that is not a radio pharmaceutical drug 
product, a product derived from human plasma pro-
tein and their recombinant analogs, or any other 
product as designated by the Secretary, 
shall notify the Secretary of a discontinuance of the manu-
facture of the drug, or an interruption of the manufacture 
of the drug that is likely to lead to a meaningful disruption 
in the manufacturer’s supply of the drug, and the reason 
for such discontinuance or interruption, in accordance 
with subsection (b). 
‘‘(b) TIMING.—A notice required by subsection (a) 
shall be submitted to the Secretary— 
‘‘(1) at least 6 months prior to the date of the 
discontinuance or interruption; or 
‘‘(2) if compliance with paragraph (1) is not 
possible, as soon as practicable. 
‘‘(c) DISTRIBUTION.—To the maximum extent prac-
ticable, the Secretary shall distribute information on the 
discontinuation or interruption of the manufacture of the 
drugs described in subsection (a) to appropriate organiza-
tions, including physician, health provider, and patient or-
ganizations, as described in section 506D. 
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lic on the Web site of the Food and Drug Adminis-
tration, with appropriate redactions made to protect 
information described in subsection (d), except that, 
if the Secretary determines that the letter under 
paragraph (1) was issued in error or, after review of 
such response, the person had a reasonable basis for 
not notifying as required under subsection (a), the 
requirements of this paragraph shall not apply.’’. 
(b) REGULATIONS.— 
(1) IN GENERAL.—Not later than 18 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services, after issuing 
a notice of proposed rule and holding a public hear-
ing, shall promulgate final regulations that imple-
ment the amendment made by subsection (a). 
(2) CONTENTS.—Such regulations shall, for 
purposes of section 506C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356c)— 
(A) define the terms ‘‘life-supporting’’, 
‘‘life-sustaining’’, and ‘‘intended for use in the 
prevention or treatment of a debilitating disease 
or condition’’; and 
(B) define the term ‘‘interruption of the 
manufacture of the drug that is likely to lead 
to a meaningful disruption in the manufactur-
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er’s supply of the drug’’ to mean a change in 
production that is highly likely to lead to more 
than a negligible reduction in the supply of the 
drug and affects the ability of the manufacturer 
to meet demand for such drug, but not to in-
clude a change in production due to matters 
such as routine maintenance or insignificant 
changes in manufacturing so long as the manu-
facturer expects to resume operations in a short 
period of time. 
SEC. 902. DRUG SHORTAGE LIST. 
Title V (21 U.S.C. 351 et seq.) is amended by insert-
ing after section 506C the following new section: 
‘‘SEC. 506D. DRUG SHORTAGE LIST. 
‘‘(a) ESTABLISHMENT.—The Secretary shall main-
tain an up-to-date list of drugs that are determined by 
the Secretary to be in shortage in the United States. 
‘‘(b) CONTENTS.—For each drug on such list, the 
Secretary shall include the following information: 
‘‘(1) The name of the drug in shortage. 
‘‘(2) The name of each manufacturer of such 
drug. 
‘‘(3) The reason for the shortage, as determined 
by the Secretary, selecting from the following cat-
egories: 
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‘‘(A) Requirements related to complying 
with good manufacturing practices. 
‘‘(B) Regulatory delay. 
‘‘(C) Shortage of an active ingredient. 
‘‘(D) Shortage of an inactive ingredient 
component. 
‘‘(E) Discontinuation of the manufacture 
of the drug. 
‘‘(F) Delay in shipping of the drug. 
‘‘(G) Demand increase for the drug. 
‘‘(4) The estimated duration of the shortage as 
determined by the Secretary. 
‘‘(c) PUBLIC AVAILABILITY.— 
‘‘(1) IN GENERAL.—Subject to paragraphs (2) 
and (3), the Secretary shall make the information in 
such list publicly available. 
‘‘(2) TRADE SECRETS AND CONFIDENTIAL IN-
FORMATION.—Nothing in this section alters or 
amends section 1905 of title 18, United States Code, 
or section 552(b)(4) of title 5 of such Code. 
‘‘(3) PUBLIC HEALTH EXCEPTION.—The Sec-
retary may choose not to make information collected 
under this section publicly available under paragraph 
(1) if the Secretary determines that disclosure of 
such information would adversely affect the public 
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health (such as by increasing the possibility of 
hoarding or other disruption of the availability of 
drug products to patients).’’. 
SEC. 903. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE. 
Section 306 of the Controlled Substances Act (21 
U.S.C. 826) is amended by adding at the end the fol-
lowing: 
‘‘(h)(1) Not later than 30 days after the receipt of 
a request described in paragraph (2), the Attorney Gen-
eral shall— 
‘‘(A) complete review of such request; and 
‘‘(B)(i) as necessary to address a shortage of a 
controlled substance, increase the aggregate and in-
dividual production quotas under this section appli-
cable to such controlled substance and any ingre-
dient therein to the level requested; or 
‘‘(ii) if the Attorney General determines that 
the level requested is not necessary to address a 
shortage of a controlled substance, the Attorney 
General shall provide a written response detailing 
the basis for the Attorney General’s determination. 
The Secretary shall make the written response pro-
vided under subparagraph (B)(ii) available to the 
public on the Web site of the Food and Drug Ad-
ministration. 
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‘‘(2) A request is described in this paragraph if— 
‘‘(A) the request pertains to a controlled sub-
stance on the list of drugs in shortage maintained 
under section 506D of the Federal Food, Drug, and 
Cosmetic Act; 
‘‘(B) the request is submitted by the manufac-
turer of the controlled substance; and 
‘‘(C) the controlled substance is in schedule 
II.’’. 
SEC. 904. EXPEDITED REVIEW OF MAJOR MANUFACTURING 
CHANGES FOR POTENTIAL AND VERIFIED 
SHORTAGES OF DRUGS THAT ARE LIFE-SUP-
PORTING, LIFE-SUSTAINING, OR INTENDED 
FOR USE IN THE PREVENTION OF A DEBILI-
TATING DISEASE OR CONDITION. 
Subsection (c) of section 506A (21 U.S.C. 356a) is 
amended by adding at the end the following new para-
graph: 
‘‘(3) CHANGES
ADDRESSING
A
DRUG
SHORT-
AGE.— 
‘‘(A) CERTIFICATION.— 
‘‘(i) DESCRIPTION.—A certification is 
described in this subparagraph if the man-
ufacturer, having notified the Secretary of 
an interruption or discontinuance of a drug 
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