(This measure has not been amended since it was reported to the House on July 24, 2014. The summary of that version is repeated here.)
Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.
Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective.
Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration (FDA).
Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient.
Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act. Directs the Commissioner of Food and Drugs to make the determination if the Director does not make a determination in the allowed timeframe.
Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products.
Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner of Food and Drugs in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.
[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>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by Unanimous Consent .
Committee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-558.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-558.
Placed on the Union Calendar, Calendar No. 418.
Mr. Whitfield moved to suspend the rules and pass the bill, as amended.
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Considered under suspension of the rules. (consideration: CR H6928-6933)
DEBATE - The House proceeded with forty minutes of debate on H.R. 4250.
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H6928-6930)
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H6928-6930)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate.