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SECTION 1. SHORT TITLE.

This Act may be cited as the ''Unlocking Lifesaving Treatments for
Rare-Diseases Act'' or ''ULTRA''.

SEC. 2. IMPROVING THE ACCELERATED APPROVAL PATHWAY FOR FAST TRACK
PRODUCTS TO SERVE THE UNMET NEEDS OF INDIVIDUALS WITH
ULTRA RARE DISEASES.

Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356) is amended by adding at the end the following:
''(e) Scientific Standards for Approval of Certain Orphan Drugs as
Fast Track Products.--
''(1) In general.--The Secretary may approve an application
for a drug designated under section 526 for a rare disease or
condition as a fast track product using a surrogate endpoint as
described under paragraph (2) if--
''(A) the Secretary makes an initial determination
that the drug is eligible for approval--
''(i) as a drug designated for a rare
disease or condition under section 526; and
''(ii) as a fast track product under this
section; and
''(B) the drug is a treatment for a disease or
condition that affects a small number of patients in
the United States, as determined by the Secretary in
designating the drug for a rare disease or condition
under section 526.
''(2) Surrogate endpoint definition for certain fast track
products.--
''(A) In general.--If a drug meets the criteria
established in paragraph (1), the Secretary--
''(i) may use a surrogate endpoint for the
approval of the drug as a fast track product
based on the existence of reasonable scientific
data that support and qualify the relevance of
the surrogate endpoint to the disease state and
treatment; and
''(ii) shall not require clinical treatment
data or other historical clinical data on the
surrogate endpoint as a prerequisite to
assessment of the surrogate endpoint under this
subsection if such data are not available.
''(B) Use of clinical data.--
''(i) Subject to subparagraph (A)(ii), in a
surrogate endpoint assessment under this
subsection, the Secretary may take into
consideration any reliable clinical data that
are readily available and published.
''(ii) For a surrogate endpoint which the
Secretary decides to use in accordance with
subparagraph (A), nothing in this subsection
shall preclude the Secretary from requiring
clinical data that makes use of the surrogate
endpoint as a condition of approval for the
fast track product.
''(C) Guidance and considerations.--Not later than
1 year after the date of enactment of the Unlocking
Lifesaving Treatments for Rare-Diseases Act, the
Secretary shall issue guidance providing details and
options for qualifying surrogate endpoints without
clinical data pursuant to this subsection. In
qualifying a surrogate endpoint under this subsection,
the Secretary shall take into account and balance the
following considerations:
''(i) The unmet need served by the drug and
the adverse effects of the rare disease or
condition on quality of life and length of
life.
''(ii) The very low likelihood that
clinical data would exist or that clinical
studies would be completed to support a
surrogate endpoint due to the small size of the
patient population in the United States and
other significant barriers inherent in
performing such clinical studies due to the
prevalence of the disease or related factors.
''(iii) The full scope of available basic
scientific data and information describing the
pathophysiology of the disease, mechanism of
action of the drug, biology of the relevant
disease pathway, information regarding the
quality of the biomarker assay, model treatment
data, or other supportive scientific
information that the Secretary deems reasonably
predictive of a clinical benefit in the absence
of clinical data.''.
Unlocking Lifesaving Treatments for Rare-Diseases Act or ULTRA - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to approve an application for a drug as a fast track product using a surrogate endpoint, based on the existence of reasonable scientific data that support and qualify the relevance of such endpoint to the disease state and treatment, if the Secretary: (1) makes an initial determination that the drug is eligible for approval as a drug designated for a rare disease or condition (orphan drug) and as a fast track product, and (2) determines that the drug is a treatment for a disease or condition that affects a small number of patients in the United States. Prohibits the Secretary from requiring clinical treatment or other historical clinical data on such endpoint as a prerequisite to assessment of that endpoint if such scientific data is not available.

Directs the Secretary to issue guidance providing details and options for qualifying surrogate endpoints without clinical data, taking into account and balancing: (1) the unmet need served by the drug and the adverse effects of the rare disease or condition on quality and length of life, (2) the very low likelihood that clinical data would exist or that clinical studies would be completed to support a surrogate endpoint due to the small size of the U.S. patient population and other significant barriers inherent in performing such studies due to the prevalence of the disease or related factors, and (3) the full scope of available basic scientific data and information that the Secretary deems reasonably predictive of a clinical benefit in the absence of clinical data.