To amend chapter V of the Federal Food, Drug, and Cosmetic Act to permit provisional approval of fast track products.

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''.

Summary: 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.