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.

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.

Summary: 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.