```

[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4250 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 4250

    To amend the Federal Food, Drug, and Cosmetic Act to provide an 
     alternative process for review of safety and effectiveness of 
  nonprescription sunscreen active ingredients and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 13, 2014

 Mr. Whitfield (for himself and Mr. Dingell) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
    To amend the Federal Food, Drug, and Cosmetic Act to provide an 
     alternative process for review of safety and effectiveness of 
  nonprescription sunscreen active ingredients 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 ``Sunscreen Innovation Act''.

SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN ACTIVE INGREDIENTS.

    Subchapter A of chapter V (21 U.S.C. 351 et seq.) is amended by 
adding at the end the following:

``SEC. 524B. PROCEDURES FOR CLASSIFYING SUNSCREEN ACTIVE INGREDIENTS.

    ``(a) In General.--The Secretary shall review and determine whether 
nonprescription sunscreen conditions are generally recognized as safe 
and effective and shall ensure that any such conditions that are 
marketed in the United States are appropriately labeled.
    ``(b) Definitions.--
            ``(1) Active ingredient.--The term `active ingredient' 
        means any component that is intended to furnish pharmacological 
        activity or other direct effect in the diagnosis, cure, 
        mitigation, treatment, or prevention of disease, or to affect 
        the structure or function of the body of humans or animals. The 
        term includes components that may undergo chemical change in 
        the manufacture of a drug and may be present in a drug in a 
        modified form intended to furnish the specified activity or 
        effect.
            ``(2) Sunscreen active ingredient.--The term `sunscreen 
        active ingredient' means an active ingredient that absorbs, 
        reflects, or scatters radiation in the ultraviolet range at 
        wavelengths from 290 to 400 nanometers.
            ``(3) Sunscreen condition.--The term `sunscreen condition' 
        means a sunscreen active ingredient (or a combination of 
        sunscreen active ingredients), dosage form, dosage strength, or 
        route of administration, marketed for a specific 
        nonprescription use.
    ``(c) Criteria for Eligibility.--To be eligible for review under 
this section, a sunscreen condition shall--
            ``(1) not be included in the stayed sunscreen monograph; 
        and
            ``(2) have been marketed as a nonprescription sunscreen 
        condition in the United States or at least 1 other country, or 
        marketed as a cosmetic or dietary supplement in 1 or more 
        counties other than the United States--
                    ``(A) for a minimum of 5 continuous years; and
                    ``(B) in sufficient quantity, as determined by the 
                Secretary based upon the information submitted under 
                subparagraphs (D) and (E) of subsection (d)(1) and, if 
                applicable, subsection (d)(2)(A)(ii).
    ``(d) Application for Eligibility.--
            ``(1) In general.--A sponsor of a nonprescription sunscreen 
        condition described in subsection (c) desiring to market such 
        condition in the United States may submit an application to the 
        Secretary, in such manner and containing such information as 
        required by the Secretary, including the following:
                    ``(A) Basic information about the sunscreen 
                condition (including a description of each active 
                ingredient, pharmacologic class, intended 
                nonprescription use, nonprescription strength and 
                dosage form, route of administration, and directions 
                for use).
                    ``(B) A detailed chemical description of the 
                sunscreen active ingredient that includes a full 
                description of the drug substance, including its 
                physical and chemical characteristics, the method of 
                synthesis (or isolation) and purification of the drug 
                substance, and any specifications and analytical 
                methods necessary to ensure the identity, strength, 
                quality, and purity of the drug substance, including 
                reference to the current edition of the official 
                National Formulary, the United States Pharmacopeia, or 
                foreign compendiums, where applicable.
                    ``(C) A list of each country in which the sunscreen 
                condition has been marketed.
                    ``(D) The cumulative total number of dosage units 
                sold for each dosage form of the sunscreen condition, 
                including total weight of the active ingredient, 
                package size for each dosage form in which the 
                condition is marketed as nonprescription, and an 
                estimate of the minimum number of potential consumer 
                exposures to the condition.
                    ``(E) The use pattern (according to the label) for 
                each country in which the sunscreen condition is 
                marketed and any changes in use pattern that have 
                occurred over time.
                    ``(F) A list of all countries in which the 
                sunscreen condition has been withdrawn from marketing 
                or in which an application for nonprescription 
                marketing approval has been denied and an explanation 
                for such withdrawal or application denial.
            ``(2) Sunscreen conditions that have not been marketed in 
        the united states for 5 continuous years.--
                    ``(A) In general.--In the case of an application 
                with respect to a nonprescription sunscreen condition 
                that has not been marketed in the United States for 5 
                continuous years, in addition to the information 
                required under paragraph (1), the sponsor shall submit 
                the following information for each country in which the 
                sunscreen condition has been marketed:
                            ``(i) The manner in which the sunscreen 
                        condition has been marketed to consumers. If 
                        the sunscreen condition is marketed to 
                        consumers as a nonprescription pharmacy only 
                        condition, the Secretary may require 
                        supplemental information.
                            ``(ii) A description of the population 
                        demographics and the source from which this 
                        information has been compiled, to ensure that 
                        the sunscreen condition's use can be reasonably 
                        extrapolated to the population of the United 
                        States.
                            ``(iii) A description of the country's 
                        system for identifying adverse drug 
                        experiences, especially those found in 
                        nonprescription marketing experience, including 
                        method of collection if applicable.
                            ``(iv) A statement of how long the 
                        sunscreen condition has been marketed in each 
                        country and how long the current product 
                        labeling has been in use, accompanied by a copy 
                        of the current product labeling, including a 
                        translation into English of any labeling that 
                        is not in English, and a statement of whether 
                        the current product labeling has been 
                        authorized, accepted, or approved by a 
                        regulatory body in each country where the 
                        condition is marketed.
                            ``(v) A list of all countries where the 
                        sunscreen condition is marketed as a 
                        prescription drug only and an explanation for 
                        such restriction.
                    ``(B) Sunscreen conditions that have been marketed 
                in more than 5 countries.--
                            ``(i) In general.--In the case of a 
                        sunscreen condition that has been marketed as a 
                        nonprescription sunscreen in more than 5 
                        countries, with a minimum of 5 continuous years 
                        of marketing in at least one such country, the 
                        sponsor--
                                    ``(I) may submit information in 
                                accordance with clauses (i) through 
                                (iv) of subparagraph (A) with respect 
                                to only 5 such countries, including--
                                            ``(aa) the country with a 
                                        minimum of 5 continuous years 
                                        of nonprescription marketing;
                                            ``(bb) the country with the 
                                        longest duration of marketing; 
                                        and
                                            ``(cc) the country with the 
                                        most support for marketing, 
                                        such as a large volume of sales 
                                        with cultural diversity among 
                                        users of the product; and
                                    ``(II) shall explain the basis for 
                                the countries selected under subclause 
                                (I); and
                                    ``(III) shall provide information 
                                from more than 5 countries if such 
                                information is needed to support the 
                                application.
                            ``(ii) Requirement.--If the sunscreen 
                        condition meets the criteria under items (aa) 
                        through (cc) of clause (i)(I) in 1 or more 
                        countries listed in section 802(b)(1)(A), at 
                        least 1 such country shall be included among 
                        the 5 countries selected under such clause 
                        (i)(I).
            ``(3) Pending applications.--The requirements of this 
        subsection shall not apply to a sunscreen condition deemed 
        eligible for review of safety and effectiveness by publication 
        of a notice of eligibility in the Federal Register prior to the 
        date of enactment of the Sunscreen Innovation Act. Applications 
        for such sunscreen conditions shall be considered in accordance 
        with subsection (g).
    ``(e) Public Availability.--If a condition is found eligible under 
subsection (d), the Secretary shall make the application publicly 
available, with redactions for confidential commercial information or 
trade secret information, and any other information exempt from 
disclosure pursuant to section 1905 of title 18, United States Code, 
section 552(b) of title 5, United States Code, or section 301(j) of 
this Act. Applications shall remain confidential during the Secretary's 
consideration of eligibility.
    ``(f) New Sunscreen Condition Application.--
            ``(1) Eligibility determination.--Not later than 60 days 
        after the submission of an eligibility application under 
        subsection (d), the Secretary shall determine if the sunscreen 
        condition is eligible for further review for safety and 
        effectiveness. In the case of a sunscreen condition determined 
        to be eligible, the Secretary shall publish a notice of 
        eligibility in the Federal Register, and provide interested 
        persons an opportunity to submit published and unpublished data 
        related to the safety and effectiveness of the sunscreen 
        condition for its intended nonprescription uses, in accordance 
        with paragraph (2). In the case of a sunscreen condition 
        determined not eligible, the Secretary shall issue a letter to 
        the sponsor, which shall be made publicly available.
            ``(2) Safety and effectiveness data submissions.--
                    ``(A) In general.--Within 60 days of the 
                publication in the Federal Register of an application 
                deemed eligible, as described in paragraph (1), the 
                sponsor and other interested parties shall submit 
                safety and effectiveness data to the Secretary for 
                further review, as described in subparagraph (B).
                    ``(B) Required submissions regarding data.--
                Submissions under this paragraph shall include the 
                following:
                            ``(i) Human safety data.--
                                    ``(I) Individual active 
                                components.--With respect to individual 
                                active components, controlled studies, 
                                partially controlled or uncontrolled 
                                studies, documented case reports, 
                                pertinent marketing experiences that 
                                may influence a determination as to the 
                                safety of each individual active 
                                component, and pertinent medical and 
                                scientific literature.
                                    ``(II) Combinations of individual 
                                active components.--With respect to 
                                combinations of the individual active 
                                components, controlled studies, 
                                partially controlled or uncontrolled 
                                studies, documented case reports, 
                                pertinent marketing experiences that 
                                may influence a determination as to the 
                                safety of combinations of the 
                                individual active component, and 
                                pertinent medical and scientific 
                                literature.
                            ``(ii) Efficacy data.--
                                    ``(I) Individual active 
                                components.--With respect to individual 
                                active components, controlled studies, 
                                partially controlled or uncontrolled 
                                studies, documented case reports, 
                                pertinent marketing experiences that 
                                may influence a determination on the 
                                efficacy of each individual active 
                                component, pertinent medical and 
                                scientific literature.
                                    ``(II) Combinations of individual 
                                active components.--With respect to 
                                combinations of the individual active 
                                components, controlled studies, 
                                partially controlled or uncontrolled 
                                studies, documented case reports, 
                                pertinent marketing experiences that 
                                may influence a determination on the 
                                efficacy of combinations of the 
                                individual active components, and 
                                pertinent medical and scientific 
                                literature.
                            ``(iii) Data setting forth medical 
                        rationale and purpose.--A summary of the data 
                        and views setting forth the medical rationale 
                        and purpose (or lack thereof) for the sunscreen 
                        condition and the scientific basis (or lack 
                        thereof) for the conclusion that the condition 
                        has been proven safe and effective for the 
                        intended use. If there is an absence of 
                        controlled studies in the material submitted, 
                        an explanation as to why such studies are not 
                        considered necessary must be included.
                            ``(iv) Official drug monograph.--An 
                        applicable United States Pharmacopoeia or 
                        National Formulary for the sunscreen active 
                        ingredient or a proposed standard for inclusion 
                        in an article to be recognized in an official 
                        drug monograph for the active ingredient, 
                        including information showing that the official 
                        or proposed compendial monograph for the active 
                        ingredient is consistent with the active 
                        ingredient used in the studies establishing 
                        safety and effectiveness and with the active 
                        ingredient marketed in the nonprescription 
                        product to a material extent and for a material 
                        time. If differences exist between the official 
                        or proposed compendial monograph for the active 
                        ingredient and the active ingredient that is 
                        the subject of the application, sponsor shall 
                        explain such differences.
                            ``(v) Adverse drug experiences.--A list of 
                        all serious adverse drug experiences, as 
                        defined by the Secretary, from each country 
                        where the condition has been or is currently 
                        marketed as a prescription drug or as a 
                        nonprescription drug or product.
                    ``(C) Optional animal safety data.--In addition to 
                the information required under subparagraph (B), the 
                sponsor may submit information with respect to animal 
                safety data, including controlled studies and partially 
                controlled or uncontrolled studies, in the case of an 
                application for individual active components, and 
                controlled studies and partially controlled or 
                uncontrolled studies in the case of an application for 
                combinations of individual active components.
                    ``(D) Confidentiality of submissions.--The 
                Secretary shall make data and information submitted by 
                the sponsor, or pursuant to a notice requesting safety 
                and effectiveness data published in the Federal 
                Register, publicly available, with redactions for 
                confidential commercial information or trade secret 
                information, and any other information exempt from 
                disclosure pursuant to section 1905 of title 18, United 
                States Code, section 552(b) of title 5, United States 
                Code, or section 301(j) of this Act.
            ``(3) New sunscreen condition application submission to the 
        advisory committee.--Not later than 30 days after the end of 
        the public comment period described in paragraph (2), the 
        Secretary shall submit the application and the safety and 
        effectiveness data submitted under paragraph (2) to the 
        Nonprescription Drugs Advisory Committee (referred to in this 
        section as the `advisory committee') for review.
    ``(g) Pending Sunscreen Condition Applications.--Not later than 30 
days after the date of enactment of the Sunscreen Innovation Act, the 
Secretary shall submit to the advisory committee all safety and 
effectiveness data submitted with respect to each application for 
review of sunscreen conditions that the Secretary had determined, prior 
to the date of enactment of the Sunscreen Innovation Act, to be 
eligible for review of safety and effectiveness and for which the 
information required under subsection (f)(2) has been submitted to the 
Secretary prior to such date of enactment.
    ``(h) Review and Recommendation for Nonprescription Sunscreen 
Condition.--
            ``(1) In general.--The Secretary shall require the advisory 
        committee to evaluate the safety and effectiveness data 
        submitted in accordance with subsection (f)(2) or (g).
            ``(2) Standards.--In evaluating a nonprescription sunscreen 
        condition under paragraph (1), the advisory committee shall use 
        the regulations in effect at the time of the application, 
        including regulations with respect to--
                    ``(A) the safety of the nonprescription sunscreen 
                condition;
                    ``(B) the effectiveness of the nonprescription 
                sunscreen condition;
                    ``(C) the benefit-to-risk ratio of the 
                nonprescription sunscreen condition; and
                    ``(D) the labeling of the nonprescription sunscreen 
                condition.
            ``(3) Communications between advisory committee and other 
        individuals who submit data.--The advisory committee shall have 
        the authority to communicate with the sponsor and other 
        individuals who submit data during the advisory committee's 
        review, including requesting clarification or additional 
        information.
            ``(4) Recommendations.--
                    ``(A) In general.--For each such submission under 
                subsection (f)(3) or (g), the advisory committee shall 
                make one of the following recommendations to the 
                Secretary:
                            ``(i) The sunscreen condition is generally 
                        recognized as safe and effective (including any 
                        or all indications), including nonprescription 
                        sunscreen conditions for which a new drug 
                        application has been approved by the Secretary.
                            ``(ii) Insufficient information has been 
                        provided to support a recommendation that the 
                        sunscreen condition is generally recognized as 
                        safe and effective (including any or all 
                        indications).
                            ``(iii) The sunscreen condition is not 
                        generally recognized as safe and effective to 
                        be marketed or sold unless an application with 
                        respect to such condition is approved under 
                        section 505(b).
                    ``(B) Timing.--The advisory committee shall make a 
                recommendation under subparagraph (A) not later than 
                180 days after the advisory committee receives the 
                application and data submitted under subsection (f)(3) 
                or subsection (g).
                    ``(C) Resubmission of data.--If the advisory 
                committee recommends that insufficient information has 
                been provided, in accordance with subparagraph (A)(ii), 
                the advisory committee shall make such recommendation 
                not later than 180 days after the date on which such 
                additional information is submitted.
    ``(i) Determination by the Center for Drug Evaluation and 
Research.--
            ``(1) In general.--The Center for Drug Evaluation and 
        Research shall respond to the recommendations of the advisory 
        committee under subsection (h)(4) as follows:
                    ``(A) In the case of a recommendation by the 
                advisory committee described in clause (i) of 
                subsection (h)(4), not later than 45 days after the 
                advisory committee issues the recommendation, the 
                Center for Drug Evaluation and Research shall issue a 
                determination affirming or denying the recommendation 
                of the advisory committee. If the Center for Drug 
                Evaluation and Research affirms the recommendation of 
                the advisory committee, or if the Center for Drug 
                Evaluation and Research takes no action regarding the 
                recommendation within 45 days of receiving such 
                recommendation, the nonprescription sunscreen condition 
                shall be generally recognized as safe and effective, 
                not misbranded, and permitted to be marketed and sold 
                in accordance with all applicable rules and regulations 
                for over-the-counter drugs.
                    ``(B) In the case of a recommendation described in 
                clause (ii) of such subsection, the Center for Drug 
                Evaluation and Research shall issue a determination 
                affirming or denying the recommendation of the advisory 
                committee, to be made publicly available, within 45 
                days of receiving the recommendation, and inform the 
                sponsor that the sponsor must submit additional 
                information to the advisory committee in order to 
                continue the review by the advisory committee.
                    ``(C) In the case of a recommendation described in 
                clause (iii) of such subsection, the Center for Drug 
                Evaluation and Research shall issue a determination 
                affirming or denying the recommendation of the advisory 
                committee, to be made publicly available, within 45 
                days of receiving such recommendation, and indicate 
                whether such sunscreen condition determined to be not 
                generally recognized as safe and effective to be 
                marketed and sold unless an application with respect to 
                such condition is approved under section 505(b), or 
                whether additional data must be submitted to the 
                advisory committee.
            ``(2) Supervisory review of determination.--
                    ``(A) In general.--Any person may request a 
                supervisory review of a determination of the Center for 
                Drug Evaluation and Research to not accept a 
                recommendation of an advisory committee. Such review 
                may be conducted at the next supervisory or higher 
                level above the individual who made the determination.
                    ``(B) Request for supervisory review.--A request 
                described in subparagraph (A) shall be made to the 
                Secretary not later than 30 days after such decision 
                and shall indicate in the request whether such person 
                seeks an in-person meeting or a teleconference. The 
                Secretary shall schedule an in-person or teleconference 
                review, if so requested, not later than 30 days after 
                such request is made. The Secretary shall issue a 
                decision to the person requesting a review under this 
                paragraph not later than 45 days after the meeting.
                    ``(C) Standard of supervisory review.--The 
                Secretary shall be authorized to overturn a 
                determination of the Center for Drug Evaluation and 
                Research not to accept a recommendation of the advisory 
                committee if the supervisory review results in a 
                decision by the reviewer that the individual who made 
                the determination did not provide reasonable and 
                sufficient substantive support for the decision to 
                disregard the advisory committee's recommendation.
                    ``(D) Supervisory review decision.--If the 
                Secretary overturns a determination by the Center for 
                Drug Evaluation and Research not to accept a favorable 
                recommendation of an advisory committee, the 
                nonprescription sunscreen condition shall be generally 
                recognized as safe and effective, not misbranded, and 
                permitted to be marketed and sold in accordance with 
                all applicable rules and regulations for over-the-
                counter drugs.
                    ``(E) Final agency action.--A decision made through 
                supervisory review shall constitute final agency action 
                subject to judicial review.
    ``(j) Reports.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Sunscreen Innovation Act, on March 1, 2015, 
        and every 2 years thereafter, the Secretary shall issue a 
        report to Congress describing actions taken under this section.
            ``(2) Contents.--The reports under paragraph (1) shall 
        include--
                    ``(A) a review of the progress made in issuing in a 
                timely manner decisions on the safety and effectiveness 
                for sunscreen conditions for applications pending as of 
                the date of enactment of the Sunscreen Innovation Act, 
                including the number of pending applications--
                            ``(i) reviewed and the decision times for 
                        each application, measured from the date of 
                        original eligibility application submission by 
                        the sponsor;
                            ``(ii) resulting in a determination of 
                        generally recognized as safe and effective and 
                        not misbranded;
                            ``(iii) resulting in a determination of not 
                        generally recognized as safe and effective and 
                        not misbranded and the reasons for such 
                        determinations; and
                            ``(iv) for which a determination has not 
                        been made, an explanation for the delay, a 
                        description of the current status of each such 
                        application, and the length of time such 
                        applications have been pending, measured from 
                        the date of original eligibility application 
                        submission by the sponsor;
                    ``(B) a review of the progress made in issuing in a 
                timely manner a decision on safety and effectiveness 
                for sunscreen condition applications submitted after 
                the date of enactment of the Sunscreen Innovation Act, 
                including the number of such applications--
                            ``(i) reviewed and the decision times for 
                        each application;
                            ``(ii) resulting in a determination of 
                        generally recognized as safe and effective and 
                        not misbranded; and
                            ``(iii) resulting in a determination of not 
                        generally recognized as safe and effective and 
                        not misbranded and the reasons for such 
                        determinations;
                    ``(C) a description of the staffing and resources 
                relating to the costs associated with the review and 
                decisionmaking pertaining to applications;
                    ``(D) a review of the progress in meeting the 
                deadlines with respect to processing applications under 
                this section;
                    ``(E) to the extent the Secretary determines 
                appropriate, recommendations for process improvements 
                in the handling of pending and new applications; and
                    ``(F) recommendations for expanding the 
                applicability of this section to nonprescription active 
                ingredients or conditions that are not related to the 
                sunscreen category of over-the-counter drugs.
            ``(3) Method.--The Secretary shall publish the reports 
        required under this subsection in the manner the Secretary 
        determines to be the most effective for efficiently 
        disseminating the report, including publication of the report 
        on the Internet website of the Food and Drug Administration.
    ``(k) Rules of Construction.--
            ``(1) Authority to withdraw or suspend.--Nothing in this 
        section shall be construed to alter the Secretary's authority 
        to withdraw or suspend from the market a drug that the 
        Secretary determines to be unsafe or ineffective.
            ``(2) Other conditions.--Nothing in the section shall 
        affect the Secretary's authority to review nonprescription 
        conditions other than sunscreen conditions.''.

SEC. 3. SUNSCREEN TESTING AND LABELING.

    Not later than 180 days after the date of enactment of this Act, 
the Secretary shall issue determinations with respect to--
            (1) the appropriate testing and labeling requirements for 
        sunscreens sold as an aerosol; and
            (2) whether sunscreen may contain a label indicating a sun 
        protection factor greater than 50.
                                 <all>
```