Patient Choice Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug.
Defines the term “adequately safe” to mean that: (1) for at least one population, the risk of death or morbidity caused directly by an adverse effect of the drug is unlikely to be greater than the combined direct and secondary risks of death or morbidity of the disease and existing therapies; or (2) the drug has had a valid marketing authorization for at least four years in specified countries and data adequate for the approval of such marketing authorization has been submitted to the Secretary.
Prohibits the Secretary from imposing any requirements for safety studies or data in addition to, or different than, the requirements for studies to establish safety for purposes of Phase 1 (initial introduction of an investigational new drug into humans) or Phase 2 (controlled clinical studies to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug).
Applies the provisional approval only to the indication for the drug: (1) which is related to the treatment of the condition with respect to which the drug was designated as a fast track product, and (2) for which the drug is demonstrated to be adequately safety.
Prescribes requirements for termination of provisional approval, withdrawal of such approval, and application of market exclusivity to fast-track approval products.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6288 Introduced in House (IH)]
112th CONGRESS
2d Session
H. R. 6288
To amend chapter V of the Federal Food, Drug, and Cosmetic Act to
permit provisional approval of fast track products.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 2, 2012
Mr. Bilbray (for himself, Mr. Griffith of Virginia, Mr. Hunter, Mr.
Boren, and Mrs. Schmidt) introduced the following bill; which was
referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend chapter V of the Federal Food, Drug, and Cosmetic Act to
permit provisional approval of fast track products.
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 ``Patient Choice Act of 2012''.
SEC. 2. PROVISIONAL APPROVAL FOR FAST TRACK PRODUCTS.
(a) In General.--Section 506 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356(d)) is amended by adding at the end the
following:
``(e) Provisional Approval.--
``(1) Provisional approval for adequately safe fast track
products.--
``(A) In general.--Subject to the requirements of
this subsection, if the Secretary determines that a
drug that is designated as a fast track product under
this section is adequately safe (as such term is
defined in paragraph (2)), the Secretary shall grant
provisional approval and the drug may be introduced
into interstate commerce on or after the date such
provisional approval is granted.
``(B) Treatment of provisional approval status.--
The provisional approval of a drug under subparagraph
(A) shall be treated in the same manner as approval of
a drug under section 505 or section 351 of the Public
Health Service Act, except that such provisional
approval shall be subject to the requirements of this
section, including the following:
``(i) The requirements under paragraph (3),
including requirements related to--
``(I) informed consent; and
``(II) continued pursuit of safety
and efficacy data for purposes of
gaining approval for such drug under
section 505 or section 351 of the
Public Health Service Act.
``(ii) The rules under paragraphs (4) and
(5) relating to the length of the termination
of the provisional approval and withdrawal of a
drug subject to provisional approval.
``(C) Request for provisional approval.--
``(i) In general.--The sponsor of a drug
that is designated as a fast track product
under this section may request that the
Secretary grant provisional approval for such
drug under subparagraph (A).
``(ii) Response to request.--Not later than
90 days after receiving such a request, the
Secretary shall either--
``(I) grant provisional approval
for the drug under subparagraph (A); or
``(II) provide notice to the
sponsor of the drug that such request
is denied.
``(2) Adequately safe defined.--
``(A) In general.--For purposes of this subsection,
with respect to a drug, the term `adequately safe'
means that--
``(i) for at least one population, the risk
of death or morbidity caused directly by an
adverse effect of the drug, as determined in
one or more safety studies or through other
data that the Secretary determines are
sufficient, is unlikely to be greater than the
combined direct and secondary risks of death or
morbidity, as established in the literature or
historical data, of--
``(I) the disease that such drug is
intended to treat; and
``(II) existing therapies
(including infection) for such disease;
or
``(ii) the drug has had a valid marketing
authorization, for a period of at least 4
years, by an authority in a country described
in section 802(b)(1)(A), or designated by the
Secretary under section 802(b)(1)(B), and data
adequate for the approval of such marketing
authorization for such drug in such country
have been submitted to the Secretary.
``(B) Limitation.--The Secretary may not impose any
requirements for purposes of the safety studies or data
under subparagraph (A)(i) that are in addition to, or
different than, the requirements for studies to
establish safety for purposes of Phase 1 or Phase 2, as
such terms are described in subsection (a) and (b),
respectively, of section 312.21 of title 21, Code of
Federal Regulations.
``(3) Requirements.--Provisional approval of a fast track
product under this subsection shall be subject to the following
requirements:
``(A) Informed consent.--
``(i) In general.--As a condition of
provisional approval under paragraph (1), the
sponsor of a drug shall ensure that, before
such drug is dispensed to an individual--
``(I) the individual shall be
informed that the drug is subject to
provisional approval based on limited
safety data and that the efficacy of
the drug has not been proven;
``(II) the individual shall be
informed of the known risks of the drug
and any unknown but reasonably
predictable risks of the drug,
including, as appropriate, potential
risks of death, complications, or
injury resulting from use of the drug,
and risks related to the potential
ineffectiveness of the drug, including
progression of the disease that may
result in death or morbidity, or the
potential for the drug to accelerate or
exacerbate the disease process; and
``(III) the individual provides
written informed consent acknowledging
that individual has been provided with
and understands the information under
subclauses (I) or (II).
``(ii) Regulations.--The Secretary shall
issue regulations on the requirements for
informed consent under clause (i). Such
regulations shall be similar to the
requirements for informed consent for human
subjects under subpart B of part 50 of title
21, Code of Federal Regulations, adjusted as
appropriate for purposes of this subsection.
``(B) Pursuit of full approval required.--A sponsor
of a drug that receives a provisional approval under
paragraph (1) shall continue to diligently conduct
appropriate studies, after such provisional approval is
granted, to--
``(i) establish that the drug has an effect
on a clinical endpoint or on a surrogate
endpoint that is reasonably likely to predict
clinical benefit; and
``(ii) collect the data necessary to
demonstrate that the drug is safe and effective
(or, in the case of a biologic, safe and
potent) for purpose of obtaining approval for
such drug under section 505(c) or section 351
of the Public Health Service Act.
``(C) Promotional materials.--During the period
that provisional approval under paragraph (1) applies
to a drug, the sponsor of the drug shall submit copies
of all promotional materials related to the drug at
least 30 days prior to dissemination of the materials.
``(D) Risk evaluation and mitigation strategy.--
``(i) In general.--Section 505-1 shall
apply to a drug subject to provisional approval
under this subsection in the same manner that
such section applies to a drug approved under
section 505 or section 351 of the Public Health
Service Act.
``(ii) Rule of construction.--Nothing in
this subparagraph shall be construed to limit
the Secretary's authority under section 505-1
to determine if a risk evaluation and
mitigation strategy is necessary.
``(E) Indication of use.--The provisional approval
under paragraph (1) shall only apply to the indication
of use for the drug--
``(i) which is related to the treatment of
the condition with respect to which such drug
was designated as a fast track product; and
``(ii) for which the drug is demonstrated
to be adequately safe.
``(4) Termination of provisional approval.--
``(A) In general.--In the case of a drug that is
not designated under section 526, the provisional
approval of the drug under paragraph (1) shall
terminate on the earlier of the following:
``(i) The date that the drug is approved
under section 505(c) or section 351 of the
Public Health Service Act.
``(ii) At the end of the 5-year period
beginning on the date on which provisional
approval was granted for such drug, except--
``(I) if the Secretary determines
that the sponsor of the drug is
diligently engaging in actions
(including conducting clinical trials)
for the purpose of seeking approval
under section 505(c) or section 351 of
the Public Health Service Act
(excluding provisional approval under
paragraph (1)) and the Secretary
determines that the sponsor requires
additional time to complete such
actions and attain such approval, the
Secretary may extend such period for an
appropriate length of time to allow the
sponsor to complete such actions and
attain such approval; or
``(II) if the Secretary determines
that the termination of the provisional
approval is adverse to protecting or
promoting the public health, the
Secretary may extend such period for an
appropriate length of time to protect
or promote the public health.
``(B) Special rule for orphan drugs.--In the case
of a drug designated under section 526, the provisional
approval of the drug under paragraph (1) shall
terminate on the date that the drug is approved under
section 505(c) or section 351 of the Public Health
Service Act.
``(C) Rule of construction.--For purposes of this
paragraph, the phrase `approved under section 505(c) or
section 351 of the Public Health Service Act' shall not
be construed to include a provisional approval under
paragraph (1).
``(5) Withdrawal.--
``(A) In general.--Subsection (b)(3) shall apply to
a drug subject to a provisional approval under this
subsection in the same manner as such subsection
applies to any fast track product.
``(B) Additional withdrawal authority.--In addition
to subparagraph (A), the Secretary may withdraw
approval of a fast track product using the expedited
procedures applied under subsection (b)(3) if the
requirements of paragraph (3)(A) have not been met with
respect to the drug.
``(6) Impact on marketing exclusivity.--The rules related
to marketing exclusivity under sections 505(c)(3)(E),
505(j)(5)(F), 505A, and 527 shall apply to a drug subject to
provisional approval under this subsection in the same manner
that such rules apply to drugs approved under section 505 or
section 351 of the Public Health Service Act, except that the
period of provisional approval under this subsection for a drug
shall be an addition to the applicable period of marketing
exclusivity for such drug.''.
(b) Misbranding for Marketing of Terminated Drug.--Section 502 of
the Federal Food, Drug, and Cosmetic Act is amended by adding at the
end the following:
``(aa) If it is a drug that is introduced or delivered for
introduction into interstate commerce after the date of the termination
of the provisional approval for such drug under section 506(e), unless,
on or before the date such drug is so introduced or delivered, such
drug is approved under section 505(c) or section 351 of the Public
Health Service Act.''.
(c) Conforming Amendments.--The chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351) is further amended--
(1) in section 502(a), by inserting ``(or an indication
subject to a provisional approval under section 506(e))'' after
``an indication approved under section 505 or under section
351(a) of the Public Health Service Act'';
(2) in section 506A--
(A) in subsection (a), by inserting ``(or a
provisional approval under section 506(e))'' after ``a
license under section 351 of the Public Health Service
Act''; and
(B) by adding at the end the following:
``(e) Special Rule for Drugs Subject to Provisional Approval.--In
the case of a drug subject to a provisional approval under section
506(e), any reference to safety and efficacy under this section shall
be treated as a reference to adequate safety, as such term is defined
for purposes of such section 506(e).'';
(3) in section 506B(a), by adding at the end the following:
``(3) Special rule for provisional approval.--A sponsor of
a drug that is subject to a provisional approval under section
506(e) shall submit the reports required under this section on
the studies conducted on such drug that are described in
section 506(e)(3)(B). For purposes of this section, such
reports shall be treated as reports on postmarketing studies
described in paragraph (1).'';
(4) in section 506(a)(2), by inserting ``(or that is
subject to a provisional approval under section 506(e))'' after
``505(j)''; and
(5) in section 551(b)(1)(A) by inserting ``(or a
provisional approval under section 506(e))'' after ``Public
Health Service Act''.
<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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