[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 2113 Introduced in Senate (IS)]

112th CONGRESS
  2d Session
                                S. 2113

   To empower the Food and Drug Administration to ensure a clear and 
 effective pathway that will encourage innovative products to benefit 
                  patients and improve public health.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 15, 2012

  Mrs. Hagan introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To empower the Food and Drug Administration to ensure a clear and 
 effective pathway that will encourage innovative products to benefit 
                  patients and improve public health.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS; REFERENCES IN ACT.

    (a) Short Title.--This Act may be cited as the ``Transforming the 
Regulatory Environment to Accelerate Access to Treatments'' or ``TREAT 
Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents; references in Act.
      TITLE I--ELEVATING FDA AND EMPOWERING OPERATIONAL EXCELLENCE

Sec. 101. Mission statement.
Sec. 102. Management Review Board.
         TITLE II--ADVANCING REGULATORY SCIENCE AND INNOVATION

Sec. 201. Chief innovation officer.
Sec. 202. Enhancing access to external scientific and medical 
                            expertise.
  TITLE III--ENABLING MODERNIZED PATIENT-CENTRIC CLINICAL DEVELOPMENT

Sec. 301. Enhancement of accelerated patient access to new medical 
                            treatments.
Sec. 302. Electronic health records.
Sec. 303. Disclosure to drug sponsors of reasons for non-approval of a 
                            new drug application.
    (c) References in Act.--Except as otherwise specified, amendments 
made by this Act to a section or other provision of law are amendments 
to such section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).

      TITLE I--ELEVATING FDA AND EMPOWERING OPERATIONAL EXCELLENCE

SEC. 101. MISSION STATEMENT.

    Section 1003(b) (21 U.S.C. 393(b)) is amended--
            (1) by redesignating paragraphs (3) and (4) as paragraphs 
        (4) and (5), respectively;
            (2) by inserting after paragraph (2), the following:
            ``(3) advance medical innovation, and strive to make novel 
        products available to those who need them, by incorporating 
        modern scientific tools, standards, methodologies, and 
        approaches to ensure the timely and effective review, and the 
        expeditious clearance, licensure, or approval, as appropriate, 
        of innovative drugs, devices, and other regulated products;''; 
        and
            (3) in paragraph (5), as so redesignated, by striking ``(1) 
        through (3)'' and inserting ``(1) through (4)''.

SEC. 102. MANAGEMENT REVIEW BOARD.

    Chapter VII (21 U.S.C. 371 et seq.) is amended by inserting after 
section 713 the following:

``SEC. 714. MANAGEMENT REVIEW BOARD.

    ``(a) In General.--Not later than 60 days after the date of 
enactment of the TREAT Act, the Secretary shall establish an advisory 
council within the Food and Drug Administration to be known as the 
Management Review Board (referred to in this section as the `Board').
    ``(b) Duties.--
            ``(1) In general.--The Board shall provide advice to the 
        Secretary regarding the management and organization of the Food 
        and Drug Administration.
            ``(2) Reports.--The Board shall--
                    ``(A) periodically review the organization and 
                responsibilities of individual offices, centers, and 
                divisions within the Food and Drug Administration 
                (referred to in this section as the `Administration') 
                in order to determine the optimal allocation of 
                responsibilities and to improve the efficiency and 
                effectiveness of each office, center, and division in 
                achieving individual and overall missions of the 
                Administration;
                    ``(B) issue proposed and final reports on whether 
                and to what extent changes should be made to the 
                management and organization of the Administration to 
                further the Administration's mission as set forth in 
                section 1003(b); and
                    ``(C) for any proposal for organizational changes 
                to which the Board gives significant consideration as a 
                recommendation, consider--
                            ``(i) the budgetary and operational 
                        consequences of the proposed change; and
                            ``(ii) an estimation of the level of 
                        resources that would be needed to implement the 
                        proposed change.
            ``(3) Consultation.--In carrying out paragraph (2), the 
        Board shall consult with--
                    ``(A) the heads of centers and divisions within the 
                Administration who are not members of the Board;
                    ``(B) other scientific leaders who are officers or 
                employees of the Administration and are not members of 
                the Board; and
                    ``(C) organizations representing regulated 
                industries, venture capital, patients, and disease 
                research, and that are not otherwise represented on the 
                Board.
            ``(4) Topics for review.--
                    ``(A) Request of secretary.--The Secretary may, at 
                any time, submit requests about management or 
                organizational issues to the Board for assessment.
                    ``(B) Public input.--The Board shall seek input 
                from the public on management and organizational issues 
                that should be assessed by the Board, at such times as 
                determined appropriate by the Board.
            ``(5) Powers.--The Board may secure directly from the 
        Administration such information as is necessary or appropriate 
        for the Board to review issues under consideration.
            ``(6) Conflict of interest exemption.--Notwithstanding any 
        other provision of law, the Board shall not be subject to 
        section 712.
    ``(c) Composition of Board.--
            ``(1) In general.--The Board shall consist of--
                    ``(A) the Secretary, who shall be a permanent 
                nonvoting member on an ex officio basis; and
                    ``(B) 21 additional members, all of whom shall be 
                voting members, in accordance with paragraph (2).
            ``(2) Voting members.--The membership of the Board shall 
        consist of the following:
                    ``(A) Officers and employees of the food and drug 
                administration.--The Secretary shall designate not less 
                than 9 individuals who are directors of centers within 
                the Administration, directors of divisions within such 
                Administration, or other similarly senior officials 
                within such Administration.
                    ``(B) Other members.--The Secretary shall designate 
                other individuals from among individuals who are not 
                officers or employees of the United States. Such 
                members shall include--
                            ``(i) individuals representing the 
                        interests of public or private academic medical 
                        centers, physicians, and patient advocacy and 
                        disease research organizations;
                            ``(ii) individuals representing the 
                        interests of industries regulated by the 
                        Administration, which shall include at least 1 
                        representative from each of the pharmaceutical, 
                        biotechnology, medical device, and food 
                        industries; and
                            ``(iii) individuals with broad expertise 
                        regarding how the Administration functions and 
                        with experience in successfully managing or 
                        consulting for large scientific research or 
                        other organizations (other than public or 
                        private entities described under clause (i)).
            ``(3) Term; vacancies.--
                    ``(A) Terms.--The members appointed under paragraph 
                (2)(B) shall be appointed for a term of 3 years, which 
                may be renewed once.
                    ``(B) Vacancies.--A vacancy on the Board--
                            ``(i) shall not affect the powers of the 
                        Board; and
                            ``(ii) shall be filled in the same manner 
                        as the original appointment was made.
    ``(d) Chair.--The Chair of the Board shall be selected by the 
Secretary from among the members of the Board appointed under 
subsection (c)(1). The term of office of the Chair shall be 3 years.
    ``(e) Meetings.--
            ``(1) In general.--The Board shall meet at the call of the 
        Chair or upon the request of the Secretary, but not fewer than 
        6 times with respect to issuing any particular report under 
        subsection (b)(2). The location of the meetings of the Board is 
        subject to the approval of the Secretary.
            ``(2) Particular meetings to receive public input.--Of the 
        meetings held under paragraph (1) with respect to proposals for 
        management or organizational changes being considered under 
        subsection (b)(2)--
                    ``(A) 1 or more shall be directed towards receiving 
                input from the pharmaceutical, medical device, and 
                biotechnology industries, clinical researchers, and the 
                physician and medical research communities to address 
                regulatory and scientific needs and opportunities 
                related to such proposals;
                    ``(B) 1 or more shall be directed towards receiving 
                input from patient advocacy, disease research 
                organizations, and consumer groups to address patient 
                and consumer needs and opportunities related to such 
                proposals; and
                    ``(C) 1 or more shall be directed towards receiving 
                input from food, cosmetic, and dietary supplement 
                industries to address regulatory and scientific needs 
                and opportunities related to such proposals.
            ``(3) Availability of information.--For each meeting held 
        under this subsection, the Secretary shall post on the Internet 
        Web site of the Administration a summary of the proceedings.
    ``(f) Compensation.--Without regard to the provisions of title 5, 
United States Code, governing appointments in the competitive service, 
and without regard to provisions of chapter 51 and subchapter III of 
chapter 53 of such title relating to classification and General 
Schedule pay rates, the Secretary may--
            ``(1) establish the Board; and
            ``(2) appoint and fix the compensation of the members of 
        the Board, except that officers and employees of the United 
        States shall not receive additional compensation for service as 
        members of such groups.
    ``(g) Reports.--
            ``(1) Public comment.--
                    ``(A) Proposed reports.--Each proposed report 
                issued under subsection (b)(2) shall be posted on the 
                Internet Web site of the Administration and made 
                available for public comment for not less than 60 days 
                prior to being made final and being submitted under 
                paragraph (2).
                    ``(B) Final reports.--Not later than 90 days after 
                receiving comments from the public on a proposed report 
                under subparagraph (A), the Board shall post a final 
                report on such Internet Web site incorporating an 
                overview of comments accepted or rejected.
            ``(2) Congressional and secretary review.--Each final 
        report issued under subsection (b)(2) shall be submitted to 
        the--
                    ``(A) the Committee on Health, Education, Labor, 
                and Pensions and the Committee on Appropriations of the 
                Senate;
                    ``(B) the Committee on Energy and Commerce and the 
                Committee on Appropriations of the House of 
                Representatives; and
                    ``(C) the Secretary.
            ``(3) Timing and frequency of reports.--Not later than 
        January 31, 2015, the Board shall issue the first report under 
        subsection (b)(2) and shall issue subsequent reports not less 
        than once every 5 years thereafter.
    ``(h) Process for Review of Recommended Organizational or 
Management Changes.--With respect to recommendations for organizational 
or management changes made in a report issued under subsection (b)(2), 
the Secretary shall, except as provided in subsection (i)(2), implement 
the recommendations in accordance with the following process:
            ``(1) Not later than 100 days after the report is submitted 
        to the Secretary under subsection (g)(2), the Secretary shall 
        initiate the applicable processes under subsection (i).
            ``(2) The recommendations shall be fully implemented not 
        later than the expiration of the 3-year period beginning on the 
        date on which such process is initiated.
    ``(i) Action by the Secretary.--
            ``(1) In general.--Not less than 60 days prior to 
        implementing any major organizational or management change 
        recommended under subsection (b)(2), the Secretary shall 
        provide notice to the congressional committees specified in 
        subsection (g)(2) of the Secretary's agreement with the 
        recommendation and the timeline for implementation.
            ``(2) Objection.--Subsection (h) shall not apply to a 
        recommendation for an organizational or management change made 
        in a report issued under subsection (b)(2) if, not later than 
        90 days after the report is submitted to the Secretary under 
        subsection (g)(2), the Secretary submits to the committees 
        specified in such subsection a notice indicating that the 
        Secretary objects to the recommended change, and setting forth 
        the reasons for such objection. For purposes of this paragraph, 
        an objection by the Secretary may be made to the entirety of 
        the recommended organizational changes contained in a report 
        issued under subsection (b)(2), or to 1 or more aspects of any 
        proposed change or changes.
            ``(3) Implementation.--Any aspect of a proposed change not 
        objected to by the Secretary in a notice under paragraph (2) 
        shall be implemented in accordance with subsection (h), except 
        as the Secretary may be directed otherwise by law.''.

         TITLE II--ADVANCING REGULATORY SCIENCE AND INNOVATION

SEC. 201. CHIEF INNOVATION OFFICER.

    Chapter X is amended--
            (1) by redesignating the second section 1011 (21 U.S.C. 
        399c) (as added by section 209(a) of Public Law 111-353) as 
        section 1011A; and
            (2) by adding at the end the following:

``SEC. 1013. OFFICE OF THE CHIEF INNOVATION OFFICER.

    ``(a) Establishment; Appointment.--The Secretary shall establish 
within the Office of the Commissioner an office to be known as the 
Office of the Chief Innovation Officer. The Secretary shall appoint a 
Chief Innovation Officer to lead such Office.
    ``(b) Duties.--The Chief Innovation Officer shall--
            ``(1) identify promising new scientific and regulatory 
        approaches to ensure the rapid development, testing, and review 
        of new drugs and devices, which may include the validation and 
        qualification of biomarkers, the adoption of novel models or 
        methodologies to enhance clinical trial design, clinical data 
        evaluation, or predictive toxicology, and the coordination and 
        optimization of efficient review processes for drugs, and 
        devices;
            ``(2) ensure that such approaches are integrated into 
        operations at all applicable levels of the Food and Drug 
        Administration, and harmonized with the approaches of other 
        applicable agencies;
            ``(3)(A) consider the recommendations of internal and 
        external bodies involved in advancing innovation in regulatory 
        science activities, such as those described in paragraph (1); 
        and
            ``(B) make such recommendations available on the Internet 
        Web site of the Food and Drug Administration;
            ``(4) develop pilot programs to implement and incorporate 
        the recommendations considered under paragraph (3) into the 
        regulatory review and approval processes of such 
        Administration; and
            ``(5) in consultation with the heads of the centers and 
        offices within such Administration, implement other pilot 
        programs as the Chief Innovation Officer determines 
        appropriate, and ensure participation by cross-disciplinary 
        teams in such implementation, as applicable.
    ``(c) Reports and Implementation Plans.--
            ``(1) Reports.--The Chief Innovation Officer shall publish 
        a report summarizing the consideration of applicable 
        recommendations evaluated under subsection (b)(3) at least once 
        every 2 years. Such reports shall--
                    ``(A) provide an explanation as to whether, how, 
                and why such recommendations will be implemented by the 
                Food and Drug Administration;
                    ``(B) provide a description of pilot programs being 
                implemented and the progress of such Administration 
                with respect to the integration of new scientific and 
                regulatory approaches into its operations in order to 
                accelerate the rapid development, review, approval, and 
                patient access to new drugs and devices;
                    ``(C) be made available for public comment for not 
                less than 60 days prior to being made final;
                    ``(D) following public comment, be finalized by the 
                Chief Innovation Officer to include an overview of 
                public comments accepted or rejected; and
                    ``(E) once finalized, be made available on the 
                Internet Web site of such Administration and submitted 
                to--
                            ``(i) the Committee on Health, Education, 
                        Labor and Pensions of the Senate; and
                            ``(ii) the Committee on Energy and Commerce 
                        of the House of Representatives.
            ``(2) Public comment regarding implementation of pilot 
        programs.--The Chief Innovation Officer shall make each plan to 
        implement a pilot program under subsection (b)(4) available for 
        public comment for not less than 60 days before the 
        implementation of the pilot program.
    ``(d) Maintenance of Authority of Centers.--Nothing in this section 
limits the authority or ability of the individual Centers of the Food 
and Drug Administration to carry out any of the actions described in 
this section.''.

SEC. 202. ENHANCING ACCESS TO EXTERNAL SCIENTIFIC AND MEDICAL 
              EXPERTISE.

    (a) Advisory Committees.--
            (1) Conflicts of interest.--Section 712(c)(2) (21 U.S.C. 
        379d-1(c)(2)) is amended--
                    (A) in subparagraph (A), by striking ``financial 
                interest that could be affected by the advice given to 
                the Secretary with respect to such matter'' and 
                inserting ``financial interest in the outcome of such 
                matter that is direct and predictable'';
                    (B) by striking subparagraph (B) and inserting the 
                following:
                    ``(B) Waiver.--
                            ``(i) In general.--If the Secretary makes a 
                        determination described in clause (ii), the 
                        Secretary may grant a waiver of the prohibition 
                        in subparagraph (A) to permit a member 
                        described in such subparagraph to--
                                    ``(I) participate as a non-voting 
                                member with respect to a particular 
                                matter considered in a committee 
                                meeting; or
                                    ``(II) participate as a voting 
                                member with respect to a particular 
                                matter considered in a committee 
                                meeting.
                            ``(ii) Determination.--A determination 
                        described under this clause may be based on 1 
                        or both of the following determinations:
                                    ``(I) The need for the services of 
                                the individual on the committee 
                                outweighs the potential for a conflict 
                                of interest created by the financial 
                                interest involved.
                                    ``(II) The financial interest is 
                                not so substantial as to be deemed 
                                likely to affect the integrity of the 
                                services provided by that 
                                individual.''; and
                    (C) by striking subparagraph (C).
            (2) Patient group representatives.--Section 505(n)(3) (21 
        U.S.C. 355(n)(3)) is amended--
                    (A) in subparagraph (C), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in subparagraph (D), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following:
                    ``(E) 2 or more members who are medical or 
                scientific experts selected from a pool of nominations 
                provided by patient advocacy or disease research 
                organizations whose interests are in the specific 
                disease or diseases proposed to be treated by the drug 
                under consideration.''.
            (3) Revised regulations.--
                    (A) In general.--The Secretary of Health and Human 
                Services shall revise and update the regulations of the 
                Food and Drug Administration relating to the 
                application of the Federal Advisory Committee Act (5 
                U.S.C. App.) to reflect updated understanding of the 
                scope of such Act, as embodied in regulations of the 
                General Services Administration (as in effect on the 
                date of enactment of this Act) and case law.
                    (B) Content.--The revised and updated regulations 
                under subparagraph (A) shall explicitly encourage 
                officials of the Food and Drug Administration to 
                utilize, to the maximum extent possible, the 
                flexibility and exceptions provided by the Federal 
                Advisory Committee Act to interact with stakeholder 
                groups outside the confines of the advisory committees 
                of such Act, including patient advocacy organizations, 
                disease specialty societies, and others.
    (b) Chief Medical Policy Officers.--Chapter X (21 U.S.C. 391 et 
seq.), as amended by section 201, is further amended by adding at the 
end the following:

``SEC. 1014. CHIEF MEDICAL POLICY OFFICERS.

    ``(a) Establishment.--The Secretary shall establish an Office of 
the Chief Medical Policy Officer within each of the following Offices 
of the Food and Drug Administration:
            ``(1) The Office of the Director of the Center for Drug 
        Evaluation and Research.
            ``(2) The Office of the Director of the Center for 
        Biologics Evaluation and Research.
            ``(3) The Office of the Director of the Center for Devices 
        and Radiological Health.
    ``(b) Selection.--Each Chief Medical Policy Officer shall be 
selected from the Senior Executive Service by the Secretary.
    ``(c) Duties.--Each Chief Medical Policy Officer shall--
            ``(1) in coordination with the Chief Innovation Officer, 
        center Directors, and other Chief Medical Policy Officers, 
        develop proactive and consistent approaches for the centers 
        within the Food and Drug Administration and the divisions 
        within such Administration that review applications for drug or 
        device approval to address emerging medical and scientific 
        policy issues bearing on new product review processes, 
        including by--
                    ``(A) advising on and regularly reviewing the 
                implementation of such approaches by such centers and 
                divisions; and
                    ``(B) implementing peer learning programs to ensure 
                the effective and consistent review and approval of new 
                drugs and devices, including the incorporation of new 
                scientific and regulatory approaches recommended by the 
                Chief Innovation Officer under section 1013(b);
            ``(2) in coordination with the center Directors, sponsors, 
        and relevant patient advocacy and disease research 
        organizations, promote earlier and improved utilization of 
        advisory committees throughout the drug and device development 
        and review processes, including at the investigational testing 
        phase, and recommend as appropriate the utilization of 
        authorities by the Secretary under section 1007 in cases where 
        the ability to obtain sufficient external experts for such 
        advisory committees is limited;
            ``(3) in coordination with the Office of Special Medical 
        Programs and appropriate Center medical and scientific 
        officers, improve reviewer access to external experts outside 
        of the advisory committee process, including utilization of 
        authorities in section 1004;
            ``(4) periodically solicit input from industry, academia, 
        and patient advocacy and disease research organizations on 
        emerging scientific and medical policy issues bearing on new 
        product review processes, including clinical trial 
        methodologies; and
            ``(5) coordinate with the Chief Innovation Officer in the 
        implementation of pilot programs under section 1013(b).
    ``(d) External Experts.--When serving as officers or employees of 
the United States, the experts described under subsection (c)(3) shall 
be considered special government employees as defined in section 202(a) 
of title 18, United States Code.''.

  TITLE III--ENABLING MODERNIZED PATIENT-CENTRIC CLINICAL DEVELOPMENT

SEC. 301. ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW MEDICAL 
              TREATMENTS.

    (a) Findings; Sense of Congress.--
            (1) Findings.--Congress makes the following findings:
                    (A) The Food and Drug Administration (referred to 
                in this section as the ``FDA'') serves a critical role 
                in helping to assure that new medicines are safe and 
                effective. Regulatory innovation is 1 element of the 
                Nation's strategy to address serious and life-
                threatening diseases or conditions by promoting 
                investment in and development of innovative treatments 
                for unmet medical needs.
                    (B) During the 2 decades following the 
                establishment of the accelerated approval mechanism, 
                advances in medical sciences, including genomics, 
                molecular biology, and bioinformatics, have provided an 
                unprecedented understanding of the underlying 
                biological mechanism and pathogenesis of disease. A new 
                generation of modern, targeted medicines is under 
                development to treat serious and life-threatening 
                diseases, some applying drug development strategies 
                based on biomarkers or pharmacogenomics, predictive 
                toxicology, clinical trial enrichment techniques, and 
                novel clinical trial designs, such as adaptive clinical 
                trials.
                    (C) As a result of these remarkable scientific and 
                medical advances, the FDA should be encouraged to 
                implement more broadly effective processes for the 
                expedited development and review of innovative new 
                medicines intended to address unmet medical needs for 
                serious or life-threatening diseases or conditions, 
                including those for rare diseases or conditions, using 
                a broad range of surrogate or clinical endpoints and 
                modern scientific tools earlier in the drug development 
                cycle when appropriate. This may result in fewer, 
                smaller, or shorter clinical trials for the intended 
                patient population or targeted subpopulation without 
                compromising or altering the high standards of the FDA 
                for the approval of drugs.
                    (D) Patients benefit from expedited access to safe 
                and effective innovative therapies to treat unmet 
                medical needs for serious or life-threatening diseases 
                or conditions.
                    (E) For these reasons, the statutory authority in 
                effect on the day before the date of enactment of this 
                Act governing expedited approval of drugs for serious 
                or life-threatening diseases or conditions should be 
                amended in order to enhance the authority of the FDA to 
                consider appropriate scientific data, methods, and 
                tools, and to expedite development and access to novel 
                treatments for patients with a broad range of serious 
                or life-threatening diseases or conditions.
            (2) Sense of congress.--It is the sense of Congress that 
        the Food and Drug Administration should apply the accelerated 
        approval and fast track provisions set forth in section 506 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356), as 
        amended by this section, to the greatest extent possible to 
        help expedite the development and availability to patients of 
        treatments for serious or life-threatening diseases or 
        conditions while maintaining appropriate safety and 
        effectiveness standards for such treatments.
    (b) Expedited Approval of Drugs for Serious or Life-Threatening 
Diseases or Conditions.--Section 506 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356) is amended to read as follows:

``SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-THREATENING 
              DISEASES OR CONDITIONS.

    ``(a) Designation of Drug as Fast Track Product.--
            ``(1) In general.--The Secretary shall, at the request of 
        the sponsor of a new drug, facilitate the development and 
        expedite the review of such drug if it is intended, whether 
        alone or in combination with one or more other drugs, for the 
        treatment of a serious or life-threatening disease or 
        condition, and it demonstrates the potential to address unmet 
        medical needs for such a disease or condition. (In this 
        section, such a drug is referred to as a `fast track product'.)
            ``(2) Request for designation.--The sponsor of a new drug 
        may request the Secretary to designate the drug as a fast track 
        product. A request for the designation may be made concurrently 
        with, or at any time 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.
            ``(3) Designation.--Within 60 calendar days after the 
        receipt of a request under paragraph (2), the Secretary shall 
        determine whether the drug that is the subject of the request 
        meets the criteria described in paragraph (1). If the Secretary 
        finds that the drug meets the criteria, the Secretary shall 
        designate the drug as a fast track product and shall take such 
        actions as are appropriate to expedite the development and 
        review of the application for approval of such product.
    ``(b) Accelerated Approval of a Drug for a Serious or Life-
Threatening Disease or Condition, Including a Fast Track Product.--
            ``(1) In general.--
                    ``(A) Accelerated approval.--The Secretary may 
                approve an application for approval of a product for a 
                serious or life-threatening disease or condition, 
                including a fast track product, under section 505(c) or 
                section 351(a) of the Public Health Service Act upon a 
                determination that the product has an effect on a 
                surrogate endpoint that is reasonably likely to predict 
                clinical benefit, or on a clinical endpoint, including 
                an endpoint that can be measured earlier than 
                irreversible morbidity or mortality, that is reasonably 
                likely to predict an effect on irreversible morbidity 
                or mortality or other clinical benefit, taking into 
                account the severity or rarity of the condition and the 
                availability of alternative treatments. The approval 
                described in the preceding sentence is referred to in 
                this section as `accelerated approval'.
                    ``(B) Evidence.--The evidence to support that an 
                endpoint is reasonably likely to predict clinical 
                benefit under subparagraph (A) may include 
                epidemiological, pathophysiological, therapeutic or 
                other evidence developed using biomarkers, for example, 
                or other scientific methods or tools.
            ``(2) Limitation.--Approval of a product under this 
        subsection may be subject to 1 or both of the following 
        requirements:
                    ``(A) That the sponsor conduct appropriate post-
                approval studies to verify and describe the predicted 
                effect on irreversible morbidity or mortality or other 
                clinical benefit.
                    ``(B) That the sponsor submit copies of all 
                promotional materials related to the product during the 
                preapproval review period and, following approval and 
                for such period thereafter as the Secretary determines 
                to be appropriate, at least 30 days prior to 
                dissemination of the materials.
            ``(3) Expedited withdrawal of approval.--The Secretary may 
        withdraw approval of a product approved under accelerated 
        approval using expedited procedures (as prescribed by the 
        Secretary in regulations which shall include an opportunity for 
        an informal hearing) if--
                    ``(A) the sponsor fails to conduct any required 
                post-approval study of the drug with due diligence;
                    ``(B) a study required to verify and describe the 
                predicted effect on irreversible morbidity or mortality 
                or other clinical benefit of the product fails to 
                verify and describe such effect or benefit;
                    ``(C) other evidence demonstrates that the product 
                is not safe or effective under the conditions of use; 
                or
                    ``(D) the sponsor disseminates false or misleading 
                promotional materials with respect to the product.
    ``(c) Review of Incomplete Applications for Approval of a Fast 
Track Product.--
            ``(1) In general.--If the Secretary determines, after 
        preliminary evaluation of clinical data submitted by the 
        sponsor, that a fast track product may be effective, the 
        Secretary shall evaluate for filing, and may commence review of 
        portions of, an application for the approval of the product 
        before the sponsor submits a complete application. The 
        Secretary shall commence such review only if the applicant--
                    ``(A) provides a schedule for submission of 
                information necessary to make the application complete; 
                and
                    ``(B) pays any fee that may be required under 
                section 736.
            ``(2) Exception.--Any time period for review of human drug 
        applications that has been agreed to by the Secretary and that 
        has been set forth in goals identified in letters of the 
        Secretary (relating to the use of fees collected under section 
        736 to expedite the drug development process and the review of 
        human drug applications) shall not apply to an application 
        submitted under paragraph (1) until the date on which the 
        application is complete.
    ``(d) Awareness Efforts.--The Secretary shall--
            ``(1) develop and disseminate to physicians, patient 
        organizations, pharmaceutical and biotechnology companies, and 
        other appropriate persons a description of the provisions of 
        this section applicable to accelerated approval and fast track 
        products; and
            ``(2) establish a program to encourage the development of 
        surrogate and clinical endpoints, including biomarkers, and 
        other scientific methods and tools that can assist the 
        Secretary in determining whether the evidence submitted in an 
        application is reasonably likely to predict clinical benefit 
        for serious or life-threatening conditions for which 
        significant unmet medical needs exist.''.
    (c) Guidance; Amended Regulations.--
            (1) Draft guidance.--Not later than 1 year after the date 
        of enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary'') 
        shall issue draft guidance to implement the amendments made by 
        this section. In developing such guidance, the Secretary shall 
        specifically consider issues arising under the accelerated 
        approval and fast track processes under section 506 of the 
        Federal Food, Drug, and Cosmetic Act, as amended by subsection 
        (b), for drugs designated for a rare disease or condition under 
        section 526 of such Act (21 U.S.C. 360bb).
            (2) Final guidance.--Not later than 1 year after the 
        issuance of draft guidance under paragraph (1), and after an 
        opportunity for public comment, the Secretary shall issue final 
        guidance.
            (3) Conforming changes.--The Secretary shall issue, as 
        necessary, conforming amendments to the applicable regulations 
        under title 21, Code of Federal Regulations, governing 
        accelerated approval.
            (4) No effect of inaction on requests.--If the Secretary 
        fails to issue final guidance or amended regulations as 
        required by this subsection, such failure shall not preclude 
        the review of, or action on, a request for designation or an 
        application for approval submitted pursuant to section 506 of 
        the Federal Food, Drug, and Cosmetic Act, as amended by 
        subsection (b).
    (d) Independent Review.--The Secretary may, in conjunction with 
other planned reviews, contract with an independent entity with 
expertise in assessing the quality and efficiency of biopharmaceutical 
development and regulatory review programs to evaluate the Food and 
Drug Administration's application of the processes described in section 
506 of the Federal Food, Drug, and Cosmetic Act, as amended by 
subsection (b), and the impact of such processes on the development and 
timely availability of innovative treatments for patients suffering 
from serious or life-threatening conditions. Any such evaluation shall 
include consultation with regulated industries, patient advocacy and 
disease research foundations, and relevant academic medical centers.
    (e) Construction.--The amendments made by this section to section 
506(b) of the Federal Food, Drug, and Cosmetic Act are intended to 
encourage the Secretary to utilize innovative approaches to the 
assessment of products under accelerated approval while maintaining 
appropriate safety and effectiveness standards for such products.

SEC. 302. ELECTRONIC HEALTH RECORDS.

    Subchapter A of chapter VII (21 U.S.C. 371 et seq.), as amended by 
section 103, is further amended by adding at the end the following:

``SEC. 715. CLINICAL INFORMATICS COORDINATOR.

    ``(a) In General.--The Secretary shall appoint, within the Office 
of the Commissioner, a Clinical Informatics Coordinator.
    ``(b) Duties.--The Clinical Informatics Coordinator shall--
            ``(1) develop a process to validate the use of health 
        information technology in clinical research and encourage the 
        use of new health information technologies in clinical research 
        protocols; and
            ``(2) establish pilot programs to explore and evaluate the 
        methods of incorporating emerging health information technology 
        to make the clinical research process more efficient.
    ``(c) Guidance.--Not later than 1 year after the conclusion of the 
pilot programs described in subsection (b)(2), the Secretary shall 
issue guidance for the conduct of clinical trials incorporating health 
information technology. The guidance shall explain how the Food and 
Drug Administration will evaluate such information when reviewing new 
drug and device applications.''.

SEC. 303. DISCLOSURE TO DRUG SPONSORS OF REASONS FOR NON-APPROVAL OF A 
              NEW DRUG APPLICATION.

    Section 505 (21 U.S.C. 355) is amended by adding at the end the 
following:
    ``(w) Notice of Reasons for Denial of a New Drug Application.--If 
the Secretary denies approval of a new drug application under this 
section or of an application with respect to a biological product under 
section 351 of the Public Health Service Act, the Secretary shall 
provide to the sponsor of such drug or biological product--
            ``(1) a written explanation of the reasons for denying such 
        application, including an explanation of the specific reasons 
        the Secretary determines that--
                    ``(A) the data submitted in the application are 
                inadequate to support approval of the drug or 
                biological product; and
                    ``(B) labeling, risk evaluation and mitigation 
                strategies under section 505-1, or postapproval studies 
                or trials are inadequate to support a determination 
                that the benefits of approval outweigh the risks; and
            ``(2) to the extent practicable, an explanation of what 
        data will be required and what endpoints will need to be met in 
        order to obtain approval.''.
                                 <all>