[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5497 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 5497
To amend the Federal Food, Drug, and Cosmetic Act to establish a time-
limited conditional approval pathway, subject to specific obligations,
for certain drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 19, 2019
Mr. Westerman (for himself, Mr. Gallagher, and Mr. Burchett) introduced
the following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to establish a time-
limited conditional approval pathway, subject to specific obligations,
for certain drugs, and for other purposes.
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 ``Conditional Approval Act''.
SEC. 2. CONDITIONAL APPROVAL OF NEW HUMAN DRUGS.
(a) In General.--Subchapter A of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at
the end the following:
``SEC. 524B. CONDITIONAL AND TIME-LIMITED APPROVAL PATHWAY FOR NEW
DRUGS.
``(a) Pathway Requirements.--The Secretary shall, at the request of
the sponsor of a new drug, grant provisional and time-limited approval
of such drug under this section, if the Secretary determines--
``(1) it is likely that the sponsor will be able to provide
comprehensive clinical data after such drug is conditionally
approved;
``(2) such drug is intended for the treatment, prevention,
or medical diagnosis of a seriously debilitating disease, a
life-threatening disease, or a chronic condition;
``(3) the expected benefits of the drug outweigh the
potential risks to patients, taking into account the fact that
additional data are still required to assess the drug and the
severity of the underlying disease or condition the drug is
intended to treat;
``(4) there are no existing meaningful treatments for the
disease or condition that the drug is intended to treat;
``(5) confirmatory clinical trials are difficult or costly
to conduct; and
``(6) such drug is intended to treat a disease or condition
for which no more than 2 meaningful treatments currently exist.
``(b) Approval Requirements.--
``(1) In general.--Not later than 180 days after the date
on which the Secretary receives a request for conditional
approval under subsection (a) with respect to a new drug, the
Secretary shall require the sponsor of such drug to--
``(A) complete in a timely manner clinical
investigations to provide full demonstration of safety
and effectiveness as described under section 505 of the
Federal Food, Drug, and Cosmetic Act or section 351 of
the Public Health Service Act, as applicable;
``(B) conduct clinical trials other than
confirmatory trials, to demonstrate a certain degree of
safety and efficacy of the drug; and
``(C) demonstrate that necessary post-market
surveillance and risk-management tools are in place
with respect to the drug.
``(2) Period of conditional approval.--The period of
conditional approval for a drug under this section is effective
for a 1-year period and is thereafter renewable by the
Secretary annually for up to 4 additional 1-year terms. A
conditional approval shall be in effect for no more than 5
years from the date of approval under this section.
``(3) Time limitation.--If any conditionally drug approved
under this section is not brought to market within 3 years of
the conditional approval, any conditional approval granted
under this section with respect to such drug shall be deemed
invalid.
``(4) Requirements.--As a condition on receipt of
conditional approval under this section, the Secretary shall
require the sponsor of the drug to agree to the following:
``(A) Complete in a timely manner such clinical
investigations to provide a full demonstration of
effectiveness as the Secretary determines to be
necessary for approval of the drug under section 505 of
this Act or section 351 of the Public Health Service
Act, as applicable.
``(B) Submit to the Secretary an annual report on
the progress of the sponsor in conducting the clinical
investigations required under this section.
``(C) Ensure that all labeling and promotional
materials for the drug bear the statement
`conditionally approved by the FDA pending a full
demonstration of effectiveness under applicable ___'
(specifying the application number assigned by the
Secretary in place of the blank).
``(5) Applying for full approval.--The sponsor of a drug
granted conditional approval pursuant to this section may, at
any point, submit an application for full approval as described
under section 505 of the Federal Food, Drug, and Cosmetic Act
or section 351 of the Public Health Service Act, as applicable.
``(6) Utilization of real world evidence to support full
approval.--The Secretary shall allow the use of real world
evidence, as defined in section 505F(b), and collected by the
sponsor of a drug during the duration of conditional approval
granted approval to this subsection, to supplement an
application for full approval, in addition to other post-
approval studies.
``(c) Limitation on Liability.--
``(1) In general.--With respect to any claim under State
law alleging that a drug sold or otherwise made available
pursuant to a grant of conditional approval under this section
is unsafe or ineffective, no liability in a cause of action
shall lie against a sponsor or manufacturer, unless the
relevant conduct constitutes reckless or willful misconduct,
gross negligence, or an intention tort under any applicable
State law.
``(2) Rule of construction.--Except as set forth in
subparagraph (A), nothing in this subsection shall be construed
to modify or otherwise affect the right of any person to bring
private action under any Federal or State product liability,
tort, consumer protection, or warranty law.
``(d) Definitions.--In this Act:
``(1) Seriously debilitating diseases.--The term `severely
debilitating diseases' means diseases or conditions that cause
major irreversible morbidity.
``(2) Life-threatening diseases.--The term `life-
threatening diseases' means--
``(A) a disease or condition where the likelihood
of death is high unless the course of the disease is
interrupted; or
``(B) a disease or condition with potentially fatal
outcomes, where the end point of clinical trial
analysis is survival.
``(3) Chronic condition.--The term `chronic condition'
means a disease or condition that--
``(A) usually lasts for 3 months or longer; and
``(B)(i) requires ongoing medical attention; or
``(ii) limits activities of daily living.''.
(b) Regulations and Guidance.--Not later than 1 year after the date
of the enactment of this Act, the Secretary of Health and Human
Services shall issue final regulations and guidance for carrying out
section 524B of the Federal Food, Drug, and Cosmetic Act.
(c) Conforming Amendment.--Section 505(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(a)) is amended by inserting ``,
or there is in effect a conditional approval under section 524B with
respect to such drug'' before the period.
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