[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1956 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 1956

 To amend the Public Health Service Act to provide for the approval of 
          similar biological products, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 19, 2007

  Mr. Inslee (for himself, Mr. Gene Green of Texas, and Ms. Baldwin) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to provide for the approval of 
          similar biological products, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Patient Protection and Innovative 
Biologic Medicines Act of 2007''.

SEC. 2. APPROVAL OF SIMILAR BIOLOGICAL PRODUCTS.

    (a) In General.--Section 351 of the Public Health Service Act (42 
U.S.C. 262) is amended--
            (1) in subsection (j), by striking ``under subsection (a)'' 
        and inserting ``under subsection (a) or (k)''; and
            (2) by adding at the end the following:
    ``(k) Similar Biological Products.--
            ``(1) Application.--
                    ``(A) Submission.--Any person may submit an 
                application under this subsection for approval of a 
                biologics license for a biological product (in this 
                section referred to as the `similar biological 
                product') that is claimed to be similar to a qualified 
                biological product (in this subsection referred to as 
                the `reference product').
                    ``(B) Definition.--In this subsection, the term 
                `qualified biological product' means a biological 
                product that is a biotechnology-derived therapeutic 
                biological product licensed under subsection (a) or a 
                biotechnology-derived therapeutic protein product 
                subject to an approved application that was submitted 
                under section 505(b)(1) of the Federal Food, Drug, and 
                Cosmetic Act.
            ``(2) Review and approval of similar biological product 
        applications.--
                    ``(A) Review.--An application submitted under this 
                subsection for a similar biological product shall be 
                reviewed--
                            ``(i) by the division that was responsible 
                        for review and approval of the reference 
                        product; and
                            ``(ii) in accordance with the procedures 
                        for review of biologics license applications 
                        established by the Secretary pursuant to 
                        subsection (a)(2)(A).
                    ``(B) Approval.--The Secretary shall approve the 
                application submitted under paragraph (1) only if--
                            ``(i) the applicant demonstrates that the 
                        similar biological product conforms to the 
                        applicable final product-class specific 
                        guidance and, on the basis of the data 
                        submitted in conformance with such guidance, 
                        the Secretary concludes the product is safe, 
                        pure, and potent;
                            ``(ii) the facility in which the similar 
                        biological product is manufactured, processed, 
                        packed, or held meets standards designed to 
                        assure that the biological product continues to 
                        be safe, pure, and potent; and
                            ``(iii) the applicant (or other appropriate 
                        person) consents to the inspection of the 
                        facility that is the subject of the 
                        application, in accordance with subsection (c).
                    ``(C) Conditions of approval.--The Secretary may 
                approve an application submitted under paragraph (1) 
                for a similar biological product--
                            ``(i) only for indications for which the 
                        reference product is approved; and
                            ``(ii) only if, with respect to each such 
                        indication, the application conforms to the 
                        applicable final product-class specific 
                        guidance, and on the basis of non-clinical and 
                        clinical data submitted regarding such 
                        indication, the Secretary concludes the product 
                        is safe, pure, and potent.
                    ``(D) Therapeutic equivalence.--The Secretary shall 
                not designate a similar biological product as 
                therapeutically equivalent to the reference product.
            ``(3) Time frames for application and authorization.--
                    ``(A) Submission of applications.--No application 
                for a similar biological product may be submitted under 
                this subsection unless--
                            ``(i) the Secretary has published under 
                        paragraph (5) final product-class specific 
                        guidance applicable to the reference product; 
                        and
                            ``(ii) not less than 12 years have elapsed 
                        from the date on which the reference product 
                        was approved or licensed.
                    ``(B) Effective date of approval.--Subject to 
                subparagraph (C), approval of an application submitted 
                under paragraph (1) shall not be made effective until 
                at least 14 years have elapsed from the date on which 
                the reference product was approved or licensed.
                    ``(C) Significant clinical benefit.--Approval of an 
                application submitted under paragraph (1) shall not be 
                made effective until at least 15 years have elapsed 
                from the date on which the reference product was 
                approved or licensed if--
                            ``(i) during the 12-year period following 
                        the approval or licensing of the reference 
                        product, the Secretary approves a supplement to 
                        the new drug or biologics license application 
                        for the reference product that seeks approval 
                        to market the reference product for a new 
                        indication; and
                            ``(ii) in the opinion of the Secretary, the 
                        new indication provides a significant clinical 
                        benefit in comparison with existing therapies.
                    ``(D) Exclusive approval pathway.--The Secretary 
                may not approve, under any other provision of law, a 
                product that is claimed to be similar to or the same as 
                a reference product.
            ``(4) Requests for issuance of product-class specific 
        guidance.--
                    ``(A) In general.--Any person may submit a request 
                to the Secretary for the issuance of product-class 
                specific guidance applicable to a qualified biological 
                product and its class.
                    ``(B) Priority.--The Secretary--
                            ``(i) in prioritizing among requests under 
                        this paragraph for guidance, shall consider 
                        likely market entry dates of similar biological 
                        products and the amount of time that will be 
                        needed to prepare the requested product-class 
                        specific guidance; and
                            ``(ii) may summarily reject frivolous or 
                        unsupported requests.
                    ``(C) Issuance of guidance.--In response to a 
                request under this paragraph, the Secretary shall--
                            ``(i) publish in the Federal Register a 
                        concept paper setting forth the specific 
                        questions to be addressed in product-class 
                        specific guidance and invite comments on the 
                        concept paper from any interested persons;
                            ``(ii) accept comments on the concept paper 
                        for not less than 4 months;
                            ``(iii) consider the public comments on the 
                        concept paper;
                            ``(iv) publish in the Federal Register 
                        proposed product-class specific guidance and 
                        invite comments on the proposed guidance from 
                        any interested persons;
                            ``(v) accept comments on the proposed 
                        guidance for not less than 6 months;
                            ``(vi) obtain the advice of the Similar 
                        Biological Products Advisory Committee with 
                        respect to the proposed guidance; and
                            ``(vii) except as provided in subparagraph 
                        (D), not later than 24 months after receipt of 
                        the initial request, publish in the Federal 
                        Register final product-class specific guidance 
                        or a determination that, given the current 
                        state of scientific and technical knowledge, it 
                        is not possible to issue product-class specific 
                        guidance setting forth data that will ensure 
                        the safety, purity, and potency of similar 
                        biological products to be covered by the 
                        guidance.
                    ``(D) Consolidation of requests.--The Secretary may 
                consolidate requests submitted under this paragraph 
                that refer to closely related products or product 
                classes. If the Secretary chooses to consolidate such 
                requests, the Secretary shall publish final product-
                class specific guidance or a determination described in 
                subparagraph (C)(vii) not later than 30 months after 
                receipt of the first request for guidance for any 
                product in the class.
            ``(5) Product-class specific guidance.--
                    ``(A) In general.--Guidance published under 
                paragraph (4) shall describe the data and information 
                that will be required in an application submitted under 
                paragraph (1).
                    ``(B) Required elements.--At a minimum, guidance 
                published under paragraph (4) shall require--
                            ``(i) data demonstrating the consistency 
                        and robustness of the manufacturing process for 
                        an active ingredient of the similar biological 
                        product and the finished formulation of the 
                        similar biological product;
                            ``(ii) data demonstrating the stability, 
                        compatibility (such as with excipients), and 
                        biological and physicochemical integrity of the 
                        active ingredient of the similar biological 
                        product;
                            ``(iii) data from physical, chemical, and 
                        biological assays fully characterizing the 
                        similar biological product, in comparison with 
                        the reference product, at both the active 
                        ingredient and finished product levels;
                            ``(iv) data from comparative nonclinical 
                        studies demonstrating that the similar 
                        biological product and the reference product 
                        have similar profiles in terms of 
                        pharmacokinetics, pharmacodynamics, toxicity, 
                        immunogenicity, and other relevant factors;
                            ``(v) data from comparative clinical trials 
                        demonstrating that the similar biological 
                        product and the reference product have similar 
                        profiles in terms of safety, purity, and 
                        potency, including pharmacokinetic studies, 
                        pharmacodynamic studies, and trials of 
                        sufficient size and duration to demonstrate 
                        that the products are similar in their safety 
                        (in terms of nature, seriousness, and frequency 
                        of adverse reactions), purity, and potency 
                        profiles; and
                            ``(vi) a plan for postmarketing safety 
                        monitoring (in addition to ordinary 
                        pharmacovigilance), including with respect to 
                        clinical trials; antibody testing and, as 
                        appropriate, other tests to investigate 
                        immunogenicity; patient registries; and other 
                        surveillance measures to monitor the clinical 
                        safety and risk-benefit balance of the similar 
                        biological product.
            ``(6) Revisions to guidance.--If a new condition of use is 
        approved for a reference product after the latest publication 
        of the final product-class specific guidance applicable to such 
        product, the Secretary shall promptly update and republish the 
        guidance in accordance with paragraphs (4) and (5) 
        (irrespective of whether a request for such revision has been 
        received under paragraph (4)(A)) to address the data and 
        information that will be required in an application under this 
        subsection for approval of the new condition of use. The 
        requirements of paragraph (2)(C) shall apply if the new 
        condition of use is a new indication.
            ``(7) Similar biological products advisory committee.--
                    ``(A) Establishment.--The Secretary shall establish 
                a Similar Biological Products Advisory Committee (in 
                this paragraph referred to as the `Committee').
                    ``(B) Duties.--The Committee shall--
                            ``(i) provide expert scientific advice and 
                        recommendations to the Secretary regarding the 
                        development and approval of similar biological 
                        products; and
                            ``(ii) in formulating such advice and 
                        recommendations, provide interested persons 
                        with a reasonable opportunity to make written 
                        and oral presentations.
                    ``(C) Membership.--
                            ``(i) Qualifications.--The Secretary shall 
                        appoint to serve on the Committee individuals 
                        with expertise on therapeutic biological 
                        products, including manufacturing, safety, 
                        effectiveness, and other relevant matters. The 
                        Secretary shall ensure that the Committee 
                        consists of members with adequately diversified 
                        expertise and practical experience in such 
                        fields as clinical medicine, biological and 
                        physical sciences, pharmacoepidemiology and 
                        postmarket safety surveillance, and related 
                        professions.
                            ``(ii) Nominations.--In appointing members 
                        of the Committee, the Secretary shall provide 
                        an opportunity for scientific, industry, and 
                        consumer organizations and the public to 
                        nominate such members.
                            ``(iii) Nonvoting members.--The Committee 
                        shall include, as nonvoting members, 
                        representatives of patient organizations, 
                        manufacturers of innovative biological 
                        products, and manufacturers of similar 
                        biological products.
                            ``(iv) Supplemental membership.--For the 
                        purpose of developing product-class specific 
                        guidance under paragraphs (4) and (5), the 
                        Secretary may supplement the membership of the 
                        Committee, or arrange for advice from another 
                        advisory committee, in order to obtain the 
                        advice of individuals with special expertise 
                        relating to any product under review.
    ``(l) Proper Name.--For purposes of this section:
            ``(1) Biotechnology-derived therapeutic proteins.--
                    ``(A) In general.--Subject to subparagraph (D), the 
                term `proper name', with respect to a biotechnology-
                derived therapeutic protein, means--
                            ``(i) the name adopted for such protein by 
                        the United States Adopted Names Council if such 
                        name is a unique USAN; or
                            ``(ii) if the biotechnology-derived 
                        therapeutic protein lacks a unique USAN, an 
                        official name designated pursuant to 
                        subparagraph (C).
                    ``(B) Unique usan.--The term `unique USAN', with 
                respect to a biotechnology-derived therapeutic protein, 
                means a name adopted for such protein by the United 
                States Adopted Names Council that has not been adopted 
                for any protein manufactured by a different person.
                    ``(C) Designation.--The Secretary shall designate 
                an official name for any biotechnology-derived 
                therapeutic protein that lacks a unique USAN. Any 
                official name designated under this subparagraph shall 
                be the only official name of that protein used in any 
                official compendium published after such name has been 
                designated. In no event, however, shall the Secretary 
                designate an official name so as to infringe a valid 
                trademark. Any designation under this subparagraph 
                shall be made by rule in accordance with section 553 of 
                title 5, United States Code.
                    ``(D) Exception.--The term `proper name', with 
                respect to a biotechnology-derived therapeutic protein 
                that was licensed by the Secretary prior to the 
                effective date of the Patient Protection and Innovative 
                Biologic Medicines Act of 2007, means the name adopted 
                for such protein by the United States Adopted Names 
                Council, irrespective of whether such name is a unique 
                USAN.
            ``(2) Other biological products.--The term `proper name', 
        with respect to a biological product that is not a 
        biotechnology-derived therapeutic protein, means--
                    ``(A) the official name designated by the Secretary 
                for such biological product pursuant to section 508 of 
                the Federal Food, Drug, and Cosmetic Act;
                    ``(B) if there is no such official name and such 
                biological product is an article recognized in an 
                official compendium, the official title thereof in such 
                compendium; or
                    ``(C) if neither subparagraph (A) nor subparagraph 
                (B) applies, the common or usual name, if any, of such 
                biological product.''.
    (b) Confidentiality.--Subsection (j) of section 351 of the Public 
Health Service Act (42 U.S.C. 262), as amended by subsection (a)(1), is 
further amended by adding at the end the following: ``The Secretary 
shall maintain the confidentiality of information submitted under this 
section for a biological product to the same extent and in the same 
manner as the Secretary maintains the confidentiality of information 
submitted under section 505 of the Federal Food, Drug, and Cosmetic Act 
for a drug.''.

SEC. 3. AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) Labeling.--Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is amended by adding at the end the following:
    ``(y) If it is a biotechnology-derived therapeutic protein, it was 
licensed under section 351 of the Public Health Service Act prior to 
the effective date of the Patient Protection and Innovative Biologic 
Medicines Act of 2007, it lacks a unique USAN, and its labeling fails 
to bear (i) its proper name (as defined in section 351(l) of the Public 
Health Service Act); (ii) its brand name or phrasing, approved by the 
Secretary, that adequately distinguishes it from other approved 
biotechnology-derived therapeutic proteins with the same proper name; 
and (iii) the following warning: `Any change in [insert the proper name 
of the product], including a change in manufacturer, should be made 
cautiously and only if authorized by and supervised by the prescribing 
health care professional.'. The requirement in the preceding sentence 
regarding the inclusion of a warning applies beginning on the date that 
is 180 days after the date of the enactment of the Patient Protection 
and Innovative Biologic Medicines Act of 2007.
    ``(z) If it is a biotechnology-derived therapeutic protein not 
subject to paragraph (y), and its labeling fails to include (i) its 
proper name (as defined in section 351(l) of the Public Health Service 
Act); and (ii) the following warning: `This product shall not be 
dispensed in substitution for another biological product that was 
prescribed to be dispensed, unless such substitution was expressly 
authorized by and is supervised by the prescribing health care 
professional.'. In the case of such a protein that is a similar 
biological product licensed under section 351(k) of the Public Health 
Service Act, the warning required by the preceding sentence shall read 
as follows: `This product shall not be dispensed in substitution for 
another biological product that was prescribed to be dispensed 
including [insert the proprietary name and proper name of the reference 
product].'''.
    (b) Dispensing.--Section 503(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(b)) is amended by adding at the end the 
following:
    ``(6) A drug that is subject to paragraph (1) and is a 
biotechnology-derived therapeutic protein licensed under section 351 of 
the Public Health Service Act shall not be dispensed unless the 
prescription specifies the drug's proprietary name or, if the drug 
lacks a proprietary name, the drug's proper name (as defined in section 
351(l) of such Act). The act of dispensing a drug contrary to the 
preceding sentence shall be deemed to be an act which results in the 
drug being misbranded while held for sale.''.

SEC. 4. REPORTS TO CONGRESS.

    (a) Extension of Approval Pathway to Other Products.--Not later 
than 2 years after the date of the enactment of this Act, and every 2 
years thereafter, the Secretary of Health and Human Services shall 
submit a report to the Congress making recommendations on whether it is 
feasible, in the current state of scientific and technical knowledge, 
to approve applications under subsection 351(k) of the Public Health 
Service Act, as added by section 2 of this Act, for biological products 
that are claimed to be similar to vaccines, blood or plasma products or 
their derivatives, gene therapy, cell processing, naturally derived 
therapeutic proteins, or other biological products that do not contain 
biotechnology-derived therapeutic proteins as their active ingredients.
    (b) Therapeutic Equivalence Determinations.--Not later than 2 years 
after the date of the enactment of this Act, and every 2 years 
thereafter, the Secretary of Health and Human Services shall submit a 
report to the Congress making recommendations on--
            (1) whether it is feasible, in the current state of 
        scientific and technical knowledge, to make therapeutic 
        equivalence determinations for similar biological products 
        approved under section 351(k) of the Public Health Service Act, 
        as added by section 2 of this Act; and
            (2) if so, the statutory criteria that should govern such 
        determinations.
                                 <all>