Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

Summary: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 This bill requires the Government Accountability Office (GAO) to study whether generic versions of certain complex drugs or certain biological drugs face significantly different challenges in meeting the approval standards of the Food and Drug Administration (FDA) than generic versions of small-molecule drugs. (Complex drugs and biological drugs can be composed of large molecules that are more difficult to fully characterize than small molecules, so it can be more difficult to demonstrate that generic versions of these drugs are the same as the brand name versions.) If the GAO determines that these generic drugs face significantly different challenges, then the GAO must also determine: (1) the evidence that should be required to demonstrate that one of these generic drugs is sufficiently similar to the brand name drug in safety, composition, and activity; (2) whether the Federal Food, Drug, and Cosmetic Act should be amended to address the approval of these generic drugs; and (3) whether the FDA should develop a policy document on the evidence that is necessary to obtain approval of these generic drugs.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Generic Complex Drugs Safety and 
Effectiveness for Patients Act of 2015''.

SEC. 2. GAO STUDY OF SCIENTIFIC ISSUES REGARDING THE CURRENT REGULATORY 
              PATHWAY FOR REVIEWING GENERIC VERSIONS OF CERTAIN COMPLEX 
              DRUG PRODUCTS.

    (a) Study by GAO.--The Comptroller General of the United States 
shall conduct a study to determine the following:
            (1) With respect to nonbiologic complex drug products that 
        have not been fully characterized (as defined in subsection 
        (e)(1)), whether the listing of such drugs as reference 
        products in generic drug applications presents unique 
        challenges in meeting approval standards that are significantly 
        different than the challenges presented by generic drug 
        applications that list small-molecule reference products.
            (2) With respect to biological products that are within the 
        scope of the exception under section 7002(e)(2) of Public Law 
        111-148 (relating to temporary authority for the approval of 
        biological products under section 505 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355)), whether the listing of 
        such biological products as reference products in generic drug 
        applications presents unique challenges in meeting approval 
        standards that are significantly different than the challenges 
        presented by generic drug applications that list small-molecule 
        reference products.
            (3) If the answer to the question under paragraph (1) or 
        (2) is that significantly different challenges are presented 
        for patients when reference products are nonbiologic complex 
        drug products that have not been fully characterized or when 
        reference products are biological products that are within the 
        scope of the exception under section 7002(e)(2) of Public Law 
        111-148:
                    (A) What degree of characterization of the proposed 
                generic version and the reference product should be 
                required in order to determine the safety and 
                effectiveness of the generic version.
                    (B) What degree of similarity should be required to 
                deem that the active ingredient of the proposed generic 
                version is the same as the active ingredient of the 
                reference product.
                    (C) What types of evidence should be required to 
                demonstrate that the proposed generic version is 
                bioequivalent to the reference product.
                    (D) What requirements should be established with 
                respect to the comparability of the manufacturing 
                process for the proposed generic version and the 
                manufacturing process for the reference product.
                    (E) Whether and to what extent clinical evidence is 
                needed to demonstrate that there is no difference in 
                immunogenicity between the proposed generic version and 
                the reference product.
                    (F) Whether and to what extent other clinical 
                evidence is needed to demonstrate that the proposed 
                generic version is as safe and effective for patients 
                as the reference product.
                    (G) Taking into account the determinations made 
                regarding the issues listed in subparagraphs (A) 
                through (F):
                            (i) Whether section 505(j) of the Federal 
                        Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
                        should be amended to establish provisions that 
                        expressly address the approval of copy versions 
                        of nonbiologic complex drug products that have 
                        not been fully characterized, provisions that 
                        expressly address the approval of copy versions 
                        of biological products that are within the 
                        scope of the exception under section 7002(e)(2) 
                        of Public Law 111-148, or both.
                            (ii) Whether section 505(b)(2) of such Act 
                        (21 U.S.C. 355(b)(2)) should be so amended.
                            (iii) Whether such Act should otherwise be 
                        so amended.
                            (iv) Whether section 351 of the Public 
                        Health Service Act (42 U.S.C. 262) should be so 
                        amended.
                    (H) Taking into account the determinations made 
                regarding the issues listed in subparagraphs (A) 
                through (F), and taking into consideration all relevant 
                guidances, draft guidances, and other agency policy 
                documents--
                            (i) whether the Food and Drug 
                        Administration should develop and provide to 
                        the public a policy document that provides a 
                        comprehensive statement of general principles 
                        on the evidence that is necessary to obtain the 
                        approval of such Administration for proposed 
                        generic versions of reference products that are 
                        nonbiologic complex drug products that have not 
                        been fully characterized or that are biological 
                        products; and
                            (ii) if so, the date by which such 
                        Administration could reasonably be expected to 
                        issue such comprehensive policy document.
    (b) Consultation.--The Comptroller General shall conduct the study 
under subsection (a) in consultation with--
            (1) the Secretary of Health and Human Services, acting 
        through the Commissioner of Food and Drugs; and
            (2) appropriate public and private entities, including 
        patient advocacy organizations, professional medical 
        associations, hospital pharmacies, scientists of academic and 
        business organizations, and representatives of the regulated 
        industry.
    (c) Required Consideration.--In carrying out the study under 
subsection (a), the Comptroller General shall consider the following:
            (1) Published clinical reports of clinically meaningful 
        (including serious) adverse events of patients to--
                    (A) generic versions of the nonbiologic complex 
                drug products that have not been fully characterized;
                    (B) generic versions of biological products; and
                    (C) the reference products.
            (2) The specific criteria that have been used by the 
        Secretary to approve generic versions of nonbiologic complex 
        drug products that have not been fully characterized or generic 
        versions of biological products.
            (3) The specific criteria specified in guidances, draft 
        guidance, and other documents issued by the Secretary regarding 
        applications under section 351(k) of the Public Health Service 
        Act (42 U.S.C. 262(k)) for the licensing of biosimilar 
        biological products.
    (d) Optional Consideration.--In carrying out the study under 
subsection (a), the Comptroller General may under subsection (c) 
consider the following information from foreign countries:
            (1) Reports described in subsection (c)(1) from foreign 
        countries that are listed in clause (i) or (ii) of section 
        802(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 382(b)(1)(A)) or are designated pursuant to section 
        802(b)(1)(B) of such Act (21 U.S.C. 382(b)(1)(B)).
            (2) The guidelines or recommendations of the pharmaceutical 
        regulatory agencies of foreign countries described in paragraph 
        (1) regarding any class of products that such an agency 
        regulates as a biosimilar biological product, but that has been 
        or could be approved as a generic drug in the United States.
            (3) Any instance where the Secretary or such foreign 
        regulatory agencies have, after approving a generic version (or 
        a foreign equivalent) of a nonbiologic complex drug product 
        that has not been fully characterized or a generic version (or 
        a foreign equivalent) of a biological product, sought a 
        clinical trial to confirm--
                    (A) the generic version (or foreign equivalent) is 
                therapeutically equivalent to the reference product (or 
                meets a similar standard, in the case of a foreign 
                regulatory agency); or
                    (B) the safety and effectiveness of the generic 
                version (or foreign equivalent).
    (e) Completion Date.--Not later than the expiration of the 2-year 
period beginning on the date of the enactment of this Act, the 
Comptroller General shall complete the study under subsection (a) and 
submit a report describing the findings and conclusions of the study to 
the Secretary, the Committee on Energy and Commerce of the House of 
Representatives, and the Committee on Health, Education, Labor, and 
Pensions of the Senate.
    (f) Definitions.--
            (1) Complex drug product not fully characterized.--For 
        purposes of this section, the terms ``complex drug product that 
        has not been fully characterized'' and ``complex drug products 
        that have not been fully characterized'', with respect to a 
        nonbiologic drug, means a drug for which--
                    (A) the active ingredient has molecular diversity;
                    (B) scientific analytic methodologies are unable to 
                fully identify the molecular structures and 
                physiochemical properties of the active ingredient; and
                    (C) the nature of the active ingredient is not 
                understood sufficiently to identity--
                            (i) all the molecular components of the 
                        drug that are involved in producing the 
                        therapeutic effect; and
                            (ii) the mechanisms of action that produce 
                        such effect.
            (2) Other definitions.--For purposes of this section:
                    (A) The term ``bioequivalent'', with respect to a 
                generic drug, has the meaning given such term in 
                section 505(j)(8)(B) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(j)(8)(B)).
                    (B) The term ``generic drug'' or ``generic 
                version'', with respect to the United States, means a 
                drug that is approved under section 505(j) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(j)).
                    (C) The term ``generic drug application'' means an 
                abbreviated application for the approval of a new drug 
                under section 505(j) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(j)).
                    (D) The term ``proposed'', with respect to a 
                generic version, means subject to a generic drug 
                application that is pending before the Food and Drug 
                Administration.
                    (E) The term ``reference product'', with respect to 
                a generic drug, has the meaning given the term ``listed 
                drug'' in section 505(j) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(j)).
                    (F) The term ``Secretary'' means the Secretary of 
                Health and Human Services.