Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to designate a combination of drugs as a significant drug combination if such combination: (1) includes two or more drugs or biological products that, when used in combination, offer the potential to significantly advance treatment for a serious or life-threatening disease and, in combination, meet the criteria for co-development of drug combinations in Food and Drug Administration (FDA) guidance; and (2) includes at least two drugs that are not approved.
Requires the Secretary to develop, publish, and revise annually a list of combinations of two or more drugs designated as significant drug combinations.
Extends the market exclusivity for a drug by six months if it is designated as a significant drug combination before it is approved as a new drug.
Requires the Secretary to review and take action on a drug in a significant drug combination designated under this Act within six months after receiving an application for approval of a new drug application or licensure of a biosimilar biological product.
Requires the Secretary, at the request of the sponsor of a drug, to expedite development and review for designated drug combinations.
Requires the Secretary to establish an interagency task force to encourage the co-development of drugs in significant drug combinations. Requires the task force to develop, revise in response to public comments, and update annually a list of types of drug combinations it recommends that the Secretary designate as significant drug combinations.
Directs the Secretary to study the impact of the extension of market exclusivity under this Act.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6502 Introduced in House (IH)]
112th CONGRESS
2d Session
H. R. 6502
To amend title V of the Federal Food, Drug, and Cosmetic Act to provide
for extensions of marketing exclusivity periods for drugs in certain
combinations of such drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 21, 2012
Mr. Bilbray (for himself, Mrs. Maloney, and Ms. DeLauro) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend title V of the Federal Food, Drug, and Cosmetic Act to provide
for extensions of marketing exclusivity periods for drugs in certain
combinations of such 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 ``Life-Threatening Diseases Compassion
through Combination Therapy Act of 2012''.
SEC. 2. PROMOTING THE DEVELOPMENT OF COMBINATIONS OF INVESTIGATIONAL
NEW DRUGS FOR SERIOUS DISEASES.
(a) In General.--Subchapter A of chapter 5 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting,
after section 505, the following new section:
``SEC. 505E. MARKETING EXCLUSIVITY AND PRIORITY REVIEW FOR SIGNIFICANT
DRUG COMBINATIONS.
``(a) Significant Drug Combination Designation.--
``(1) In general.--The Secretary may designate a
combination of drugs as a significant drug combination if such
combination of drugs--
``(A) includes 2 or more drugs (which may include
one or more biologics subject to licensure under
section 351 of the Public Health Service Act) that--
``(i) when used in combination, offer the
potential to significantly advance treatment
for a serious or life-threatening disease; and
``(ii) in combination, meet the criteria
for codevelopment of drug combinations, as
specified in the Food and Drug Administration's
guidance document entitled `Guidance for
Industry: Codevelopment of Two or More
Unmarketed Investigational Drugs for Use in
Combination' or a successor document; and
``(B) includes at least 2 drugs that, as of the
date on which such designation is made, are not
approved under section 505 of this Act or licensed
under section 351 of the Public Health Service Act.
``(2) Purpose.--The purpose of the designation under
paragraph (1) is to encourage the codevelopment of such drug
combinations.
``(3) Task force recommendations.--In making designations
under paragraph (1), the Secretary shall take into account the
recommendations submitted by the codevelopment task force under
section 3(c)(1) of the Life-Threatening Diseases Compassion
through Combination Therapy Act of 2012.
``(4) Requests.--
``(A) In general.--The manufacturer or sponsor of a
drug may request that the Secretary determine whether a
combination of 2 or more drugs is a significant drug
combination.
``(B) Response to request.--Not later than 30 days
after the submission of the request under subparagraph
(A), the Secretary shall review the request and--
``(i) if the combination of drugs subject
to the request has previously been designated
under paragraph (1) and the combination of
drugs continues to meet the requirements for
such a designation, the Secretary shall provide
notice to the person who submitted the request
that such combination of drugs is a significant
drug combination;
``(ii) if the combination of drugs subject
to the request has not previously been
designated under paragraph (1), but the
combination of drugs meets the requirements for
such a designation, the Secretary shall
designate such drug as a significant drug
combination under paragraph (1) and provide
notice to the person who submitted the request
that such combination of drugs is a significant
drug combination; or
``(iii) if the combination of drugs subject
to the request does not meet the requirements
for designation as a significant drug
combination under paragraph (1), the Secretary
shall provide notice to the person who
submitted the request that such combination of
drugs is not a significant drug combination.
``(C) Deadline.--A request for designation under
subparagraph (A) shall be made concurrently with, or
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, but
not later than the first date on which phase I trials
for any of the drugs involved in the drug combination
are completed.
``(b) List of Significant Drug Combinations.--
``(1) Initial list.--Not later than 180 days after the date
of enactment of the Life-Threatening Diseases Compassion
through Combination Therapy Act of 2012, the Secretary shall
develop, and shall publish on the public Web site of the Food
and Drug Administration, an initial list of combinations of 2
or more drugs that the Secretary has designated as significant
drug combinations under subsection (a).
``(2) Update.--The Secretary shall revise and update the
list under paragraph (1) on an annual basis--
``(A) to include additional drug combinations that
the Secretary has designated as significant drug
combinations under subsection (a); and
``(B) to exclude drug combinations which were
previously designated as significant drug combinations
under subsection (a), but which no longer meet the
requirements of subsection (a)(1)(B) (relating to the
minimum number of unapproved drugs in a significant
drug combination).
``(c) Extension of Market Exclusivity.--
``(1) In general.--If, prior to approval of a drug pursuant
to an application submitted under section 505(b), the Secretary
designated a significant drug combination under subsection (a)
that includes such drug, then the four- and five-year periods
described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of
section 505, the three-year periods described in clauses (iii)
and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of
subsection (j)(5)(F) of section 505, or the seven-year period
described in section 527, as applicable, shall be extended by 6
months for such drug.
``(2) Limitations.--Paragraph (1) does not apply to the
approval of--
``(A) a supplement to an application under section
505(b) for a drug in a designated significant drug
combination, if an extension described in paragraph (1)
is in effect or has expired for the original
application (or a prior supplement to such
application); or
``(B) a subsequent application filed by the same
sponsor or manufacturer of a drug in a designated
significant drug combination described in subparagraph
(A) (or a licensor, predecessor in interest, or other
related entity) for--
``(i) a change (not including a
modification to the structure of the drug) that
results in a new indication, route of
administration, dosing schedule, dosage form,
delivery system, delivery device, or strength;
or
``(ii) a modification to the structure of
the drug that does not result in a change in
safety or effectiveness.
``(d) Priority Review.--If a drug is a drug in a significant drug
combination designated under subsection (a), the Secretary shall review
and take action on any application submitted for such drug under
section 505(b) or section 351(k) not later than 6 months after receipt
by the Secretary of such application.
``(e) Significantly Advance Treatment Definition.--For purposes of
this section, the phrase `significantly advance treatment' means, with
respect to a drug combination--
``(1) the drug combination provides for the treatment of
one or more life-threatening or other serious diseases or
conditions for which no therapy exists; or
``(2) if one or more therapies are available for the
treatment of such a disease or condition, the drug combination
is demonstrated, through clinical investigations to cause one
or more improved effects on serious outcomes of the disease or
condition that are affected by alternative therapies, such as--
``(A) superiority of the drug combination; or
``(B) the drug combination minimizes the
development of drug resistance,
in an active controlled trial assessing an endpoint reflecting
serious morbidity.''.
(b) Fast Track Product.--Paragraph (1) of section 506(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)) is amended by
inserting after ``if it is intended for the treatment of a serious or
life-threatening condition and it demonstrates the potential to address
unmet medical needs for such a condition'' the following: ``or if such
drug is a drug in a significant drug combination designated under
section 505E(a)''.
SEC. 3. CODEVELOPMENT TASK FORCE.
(a) Establishment.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human Services shall
establish an interagency task force for the purpose of encouraging the
codevelopment of drugs in significant drug combinations.
(b) Membership.--The membership of the task force under subsection
(a) shall include experts on--
(1) basic and translational research; and
(2) preclinical and clinical drug development related to
serious and life-threatening diseases, including cancer.
(c) Duties.--The task force under subsection (a) shall have the
following duties:
(1) Recommended significant drug combination list.--
(A) Initial recommendations.--The task force shall
develop a list of types of drug combinations that the
task force recommends that the Secretary designate as
significant drug combinations under section 505E of the
Federal Food, Drug, and Cosmetic Act.
(B) Public comment.--The task force shall make the
list developed under subparagraph (A) publicly
available, and shall provide an opportunity for members
of the public to comment on the content of such list.
(C) Revised recommendations.--Not later than 60
days after making the list publicly available under
subparagraph (B), the task force shall revise the list
under subparagraph (A) in response to the comments
received under subparagraph (B) and shall submit such
revised list to the Secretary and the Congress.
(D) Updates.--On an annual basis, the task force
shall submit to the Secretary and the Congress updates
to the list under subparagraph (C), after making such
updates publicly available and providing an opportunity
for public comment.
(2) Policy report.--
(A) In general.--Not later than one year after the
date of enactment of this Act, and annually thereafter,
the task force shall submit to the Secretary and the
Congress a report that--
(i) identifies--
(I) issues that present challenges
to the codevelopment of drugs in
significant drug combinations; and
(II) opportunities to further
support the codevelopment of drugs in
significant drug combinations; and
(ii) contains recommendations to the
Secretary and the Congress on policy changes
that could provide additional support for the
codevelopment of drugs in significant drug
combinations.
(B) Public comment.--Before submitting the report
under subparagraph (A), the task force shall make a
draft of the report publicly available, and shall
provide an opportunity for members of the public to
comment on such report.
(d) Application of FACA.--Section 14 of the Federal Advisory
Committee Act shall not apply to the duration of the task force under
subsection (a).
(e) Significant Drug Combination Defined.--For purposes of this
section, the term ``significant drug combination'' means a combination
of 2 or more drugs (which may include one or more biologics subject to
licensure under section 351 of the Public Health Service Act) that--
(1) when used in combination, offer the potential to
significantly advance treatment for a serious or life-
threatening disease;
(2) in combination, meet the criteria for codevelopment of
drug combinations, as specified in the Food and Drug
Administration's guidance document entitled ``Guidance for
Industry: Codevelopment of Two or More Unmarketed
Investigational Drugs for Use in Combination'' or a successor
document; and
(3) includes at least 2 drugs that are not approved under
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or licensed under section 351 of the Public Health
Service Act (42 U.S.C. 262).
SEC. 4. STUDY.
(a) In General.--The Secretary of Health and Human Services shall
conduct a study on the impact of the extensions of exclusivity under
section 505E(c) of the Federal Food, Drug, and Cosmetic Act, as added
by section 2, on the development of significant drug combinations, as
defined in section 3(e).
(b) Interim Findings.--The Secretary shall--
(1) make the interim findings from the study under
subsection (a) available to the task force under section 4 and
the public; and
(2) shall provide an opportunity for the task force and
members of the public to make comments on such findings.
(c) Final Findings.--Not later than 5 years after the date of the
enactment of this Act, after providing the opportunity for comment
described in subsection (b), the Secretary shall submit the findings of
the study under subsection (a) to the Congress.
<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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