Faster Access to Specialized Treatments Act or FAST Act - Expresses the sense of Congress that the Food and Drug Administration (FDA) should apply specified accelerated approval and the fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining appropriate safety and effectiveness standards.
Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a new drug, to include as a fast track product a new drug, either alone or in combination with one or more other drugs, that is intended for the treatment of a serious or life-threatening disease or condition.
Permits the Secretary to approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, upon a determination that the product has an effect on: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) on a clinical endpoint, including an endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
Directs the Secretary, in conjunction with other planned reviews of the new drug review process, to contract with an independent entity with expertise in assessing biopharmaceutical development and regulatory review programs to evaluate the FDA's application of the fast track processes on the development and availability of innovative treatments for patients suffering from serious or life-threatening conditions.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4132 Introduced in House (IH)]
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 Cosmetic Act to
expedited approval of drugs for serious or life-threatening diseases or
conditions.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Faster Access to Specialized
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 medicines are safe
and effective. Regulatory innovation is one element of the
Nation's strategy to address serious and life-threatening
diseases or conditions by promoting investment in and
development of innovative treatments for unmet medical needs.
(2) Over the previous two decades, since the accelerated
approval mechanism was established, advances in medical
sciences, including genomics, molecular biology, and
bioinformatics, have provided an unprecedented understanding of
the underlying biological mechanism and pathogenesis of
disease. A new generation of modern, targeted medicines is
currently under development to treat serious and life-
threatening diseases, some applying drug development 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 a broad
range of surrogate or clinical endpoints and modern scientific
tools earlier in the drug development cycle when appropriate.
This may result in fewer, smaller, or shorter clinical trials
for the intended 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 authority
governing expedited approval of drugs or serious or life-
threatening conditions should be amended in order to enhance
FDA's authority to consider appropriate scientific data,
methods, and tools, and to expedite development and access to
novel treatments for patients with a broad range oofserious or
life-threatening diseases or conditions.
(b) Sense of Congress.--It is the sense of Congress that the Food
and Drug Administration should apply the accelerated approval and the
fast track provisions 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 development and
availability to patients of treatments for serious or life-threatening
diseases or conditions while maintaining appropriate safety and
effectiveness standards for such treatments.
SEC. 3. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-THREATENING
DISEASES OR CONDITIONS.
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 CONDITIONS.
``(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 serious or life-threatening disease or
condition, and it demonstrates the potential to address unmet
medical needs for such a disease or condition. (In this
section, such a drug is referred to as a `fast track product'.)
``(2) Request for designation.--The sponsor of a new drug
may request the Secretary to designate 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 described in paragraph (1). If the Secretary
finds that the drug meets the criteria, the Secretary shall
designate 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 approval of such product.
``(b) Accelerated Approval of a Drug for a Serious or Life-
Threatening Disease or Condition, Including a Fast Track Product.--
``(1) In general.--The Secretary may approve an application
for approval of a product for a serious or life-threatening
disease or condition, including a fast track product, under
section 505(c) or section 351(a) of the Public Health Service
Act upon making a determination (taking into account the
severity or rarity of the disease or condition and the
availability of alternative treatments) that the product has an
effect on--
``(A) a surrogate endpoint that is reasonably
likely to predict clinical benefit; or
``(B) a clinical endpoint, including an endpoint
that can be measured earlier than irreversible
morbidity or mortality, that is reasonably likely to
predict an effect on irreversible morbidity or
mortality or other clinical benefit.
The evidence to support that an endpoint is reasonably likely
to predict clinical benefit may include epidemiological,
pathophysiologic, pharmacologic, therapeutic or other evidence
developed using, for example, 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 requirements--
``(A) that the sponsor conduct appropriate post-
approval studies to verify and describe the predicted
effect of the product on irreversible 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 materials
during--
``(i) the preapproval review period; and
``(ii) following approval, for a period
that the Secretary determines to be
appropriate.
``(3) Expedited withdrawal of approval.--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 opportunity
for an informal hearing) if--
``(A) the sponsor fails to conduct any required
post-approval study of the product with due diligence;
``(B) a study required to verify and describe the
predicted effect on irreversible morbidity or mortality
or other clinical benefit of the product fails to
verify and describe such effect or benefit;
``(C) other evidence demonstrates that the product
is not safe or effective under the conditions 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 determines, after
preliminary evaluation of clinical data submitted by the
sponsor, that a fast track product may be effective, the
Secretary shall evaluate for filing, and may commence review of
portions of, an application for the approval of the product
before the sponsor submits a complete application. The
Secretary shall commence such review only if the applicant--
``(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 identified in letters of the
Secretary (relating to the use of fees collected under section
736 to expedite the drug development process and the review of
human drug applications) shall not apply to an application
submitted under paragraph (1) until the date on which the
application is complete.
``(d) Awareness Efforts.--The Secretary shall--
``(1) develop and disseminate to physicians, patient
organizations, pharmaceutical and biotechnology companies, and
other appropriate persons a description of the provisions of
this section applicable to accelerated approval and fast track
products; and
``(2) establish a program to encourage the development of
surrogate and clinical endpoints, including biomarkers, and
other scientific methods and tools that can assist the
Secretary in determining whether the evidence submitted in an
application is reasonably likely to predict clinical benefit
for serious or life-threatening conditions for which there
exist significant unmet medical needs.''.
SEC. 4. GUIDANCE; AMENDED REGULATIONS.
(a) Initial Guidance.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human Services
(hereinafter ``the Secretary'') shall issue draft guidance to implement
the amendments made by section 3.
(b) Final Guidance.--Not later than one year after the issuance of
draft guidance under subsection (a), after an opportunity for public
comment, the Secretary shall issue--
(1) final guidance to implement the amendments made by
section 3; and
(2) amend the regulations governing accelerated approval in
parts 314 and 601 of title 21, Code of Federal Regulations, as
necessary to conform such regulations with the amendments made
by section 3.
(c) Considerations.--In developing the guidance under subsections
(a) and (b)(1) and the amendments under subsection (b)(2), the
Secretary shall consider--
(1) issues arising under the accelerated approval and fast
track processes under section 506 of the Federal Food, Drug,
and Cosmetic Act (as amended by section 3) for drugs designated
for a rare disease or condition under section 526 of the
Federal, Food, Drug, and Cosmetic Act; and
(2) how to incorporate novel approaches to the review of
surrogate endpoints based on pathophysiologic and pharmacologic
evidence in such guidance, especially in instances where the
low prevalence of a disease renders the existence or collection
of other types of data unlikely or impractical.
(d) No Delay in Review or Approval.--The issuance (or non-issuance)
of guidance or conforming regulations implementing the amendments made
by section 3 shall not preclude the review of, or action on, a request
for designation or an application for approval submitted pursuant to
section 506 of the Federal Food, Drug, and Cosmetic Act, as amended by
section 3.
SEC. 5. INDEPENDENT REVIEW.
(a) In General.--The Secretary shall, in conjunction with other
planned reviews of the new drug review process, contract with an
independent entity with expertise in assessing the quality and
efficiency of biopharmaceutical development and regulatory review
programs, to evaluate the Food and Drug Administration's application of
the processes described in section 506 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 3, and the impact of such processes
on the development and timely availability of innovative treatments for
patients suffering from serious or life-threatening conditions.
(b) Consultation.--Any evaluation under subsection (a) shall
include consultation with regulated industries, patient advocacy and
disease research foundations, and relevant academic medical centers.
SEC. 6. RULE OF CONSTRUCTION.
The amendments made to section 506(b) of the Federal Food, Drug and
Cosmetic Act by this Act shall be construed in a manner that encourages
the Secretary to utilize innovative approaches for the assessment of
products under accelerated approval while maintaining appropriate
safety and effectiveness standards for such products.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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