I 
112TH CONGRESS 
2D SESSION 
H. R. 4132 
To amend section 506 of the Federal Food, Drug, and Cosmetic Act to 
expedited approval of drugs for serious or life-threatening diseases or 
conditions. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 5, 2012 
Mr. STEARNS (for himself and Mr. TOWNS) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend section 506 of the Federal Food, Drug, and Cos-
metic Act to expedited approval of drugs for serious 
or life-threatening diseases or conditions. 
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 ‘‘Faster Access to Spe-
cialized Treatments Act’’ or ‘‘FAST Act’’. 
SEC. 2. FINDINGS; SENSE OF CONGRESS. 
(a) FINDINGS.—Congress finds the following: 
(1) The Food and Drug Administration (FDA) 
serves a critical role in helping to assure that new 
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medicines are safe and effective. Regulatory innova-
tion is one element of the Nation’s strategy to ad-
dress serious and life-threatening diseases or condi-
tions by promoting investment in and development 
of innovative treatments for unmet medical needs. 
(2) Over the previous two decades, since the ac-
celerated approval mechanism was established, ad-
vances in medical sciences, including genomics, mo-
lecular biology, and bioinformatics, have provided an 
unprecedented understanding of the underlying bio-
logical mechanism and pathogenesis of disease. A 
new generation of modern, targeted medicines is cur-
rently under development to treat serious and life- 
threatening diseases, some applying drug develop-
ment 
strategies 
based 
on 
biomarkers 
or 
pharmacogenomics, predictive toxicology, clinical 
trial enrichment techniques, and novel clinical trial 
designs, such as adaptive clinical trials. 
(3) As a result of these remarkable scientific 
and medical advances, FDA should be encouraged to 
implement more broadly effective processes for the 
expedited development and review of innovative new 
medicines intended to address unmet medical needs 
for serious or life-threatening diseases or conditions, 
including those for rare diseases or conditions, using 
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a broad range of surrogate or clinical endpoints and 
modern scientific tools earlier in the drug develop-
ment cycle when appropriate. This may result in 
fewer, smaller, or shorter clinical trials for the in-
tended patient population or targeted subpopulation 
without compromising or altering FDA’s existing 
high standards for the approval of drugs. 
(4) Patients benefit from expedited access to 
safe and effective innovative therapies to treat 
unmet medical needs for serious or life-threatening 
diseases or conditions. 
(5) For these reasons, the existing statutory au-
thority governing expedited approval of drugs or se-
rious or life-threatening conditions should be amend-
ed in order to enhance FDA’s authority to consider 
appropriate scientific data, methods, and tools, and 
to expedite development and access to novel treat-
ments for patients with a broad range oofserious or 
life-threatening diseases or conditions. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that the Food and Drug Administration should 
apply the accelerated approval and the fast track provi-
sions set forth in section 506 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356), as amended by section 
3, to the greatest extent possible to help expedite the de-
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velopment and availability to patients of treatments for 
serious or life-threatening diseases or conditions while 
maintaining appropriate safety and effectiveness stand-
ards for such treatments. 
SEC. 3. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR 
LIFE-THREATENING 
DISEASES 
OR 
CONDI-
TIONS. 
Section 506 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356) is amended to read as follows: 
‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 
OR LIFE-THREATENING DISEASES OR CONDI-
TIONS. 
‘‘(a) DESIGNATION
OF DRUG
AS
A FAST TRACK 
PRODUCT.— 
‘‘(1) IN GENERAL.—The Secretary shall, at the 
request of the sponsor of a new drug, facilitate the 
development and expedite the review of such drug if 
it is intended, whether alone or in combination with 
one or more other drugs, for the treatment of a seri-
ous or life-threatening disease or condition, and it 
demonstrates the potential to address unmet medical 
needs for such a disease or condition. (In this sec-
tion, such a drug is referred to as a ‘fast track prod-
uct’.) 
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‘‘(2) REQUEST FOR DESIGNATION.—The spon-
sor of a new drug may request the Secretary to des-
ignate the drug as a fast track product. A request 
for the designation may be made concurrently with, 
or at any time after, 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.—Within 60 calendar days 
after the receipt of a request under paragraph (2), 
the Secretary shall determine whether the drug that 
is the subject of the request meets the criteria de-
scribed in paragraph (1). If the Secretary finds that 
the drug meets the criteria, the Secretary shall des-
ignate the drug as a fast track product and shall 
take such actions as are appropriate to expedite the 
development and review of the application for ap-
proval of such product. 
‘‘(b) ACCELERATED APPROVAL OF A DRUG FOR A 
SERIOUS OR LIFE-THREATENING DISEASE OR CONDI-
TION, INCLUDING A FAST TRACK PRODUCT.— 
‘‘(1) IN GENERAL.—The Secretary may approve 
an application for approval of a product for a seri-
ous or life-threatening disease or condition, including 
a fast track product, under section 505(c) or section 
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351(a) of the Public Health Service Act upon mak-
ing a determination (taking into account the severity 
or rarity of the disease or condition and the avail-
ability of alternative treatments) that the product 
has an effect on— 
‘‘(A) a surrogate endpoint that is reason-
ably likely to predict clinical benefit; or 
‘‘(B) a clinical endpoint, including an end-
point that can be measured earlier than irre-
versible morbidity or mortality, that is reason-
ably likely to predict an effect on irreversible 
morbidity or mortality or other clinical benefit. 
The evidence to support that an endpoint is reason-
ably likely to predict clinical benefit may include epi-
demiological, pathophysiologic, pharmacologic, thera-
peutic or other evidence developed using, for exam-
ple, biomarkers, or other scientific methods or tools. 
‘‘(2) LIMITATION.—Approval of a product 
under this subsection may, as determined by the 
Secretary, be subject to the following require-
ments— 
‘‘(A) that the sponsor conduct appropriate 
post-approval studies to verify and describe the 
predicted effect of the product on irreversible 
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morbidity or mortality or other clinical benefit; 
and 
‘‘(B) that the sponsor submit copies of all 
promotional materials related to the product, at 
least 30 days prior to dissemination of the ma-
terials during— 
‘‘(i) the preapproval review period; 
and 
‘‘(ii) following approval, for a period 
that the Secretary determines to be appro-
priate. 
‘‘(3) 
EXPEDITED
WITHDRAWAL
OF
AP-
PROVAL.—The Secretary may withdraw approval of 
a product approved pursuant to this subsection 
using expedited procedures (as prescribed by the 
Secretary in regulations, which shall include an op-
portunity for an informal hearing) if— 
‘‘(A) the sponsor fails to conduct any re-
quired post-approval study of the product with 
due diligence; 
‘‘(B) a study required to verify and de-
scribe the predicted effect on irreversible mor-
bidity or mortality or other clinical benefit of 
the product fails to verify and describe such ef-
fect or benefit; 
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‘‘(C) other evidence demonstrates that the 
product is not safe or effective under the condi-
tions of use; or 
‘‘(D) the sponsor disseminates false or 
misleading promotional materials with respect 
to the product. 
‘‘(c) REVIEW OF INCOMPLETE APPLICATIONS FOR 
APPROVAL OF A FAST TRACK PRODUCT.— 
‘‘(1) IN
GENERAL.—If the Secretary deter-
mines, after preliminary evaluation of clinical data 
submitted by the sponsor, that a fast track product 
may be effective, the Secretary shall evaluate for fil-
ing, and may commence review of portions of, an ap-
plication for the approval of the product before the 
sponsor submits a complete application. The Sec-
retary shall commence such review only if the appli-
cant— 
‘‘(A) provides a schedule for submission of 
information necessary to make the application 
complete; and 
‘‘(B) pays any fee that may be required 
under section 736. 
‘‘(2) EXCEPTION.—Any time period for review 
of human drug applications that has been agreed to 
by the Secretary and that has been set forth in goals 
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