[Congressional Record Volume 160, Number 119 (Monday, July 28, 2014)]
[House]
[Pages H6928-H6933]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SUNSCREEN INNOVATION ACT
Mr. WHITFIELD. Mr. Speaker, I move to suspend the rules and pass the
bill (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,
as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 4250
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.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by adding at the end the
following:
``Subchapter I--Nonprescription Sunscreen Active Ingredients
``SEC. 586. DEFINITIONS.
``In this subchapter:
``(1) The term `Advisory Committee' means the
Nonprescription Drug Advisory Committee or any successor to
such Committee.
``(2) The terms `generally recognized as safe and
effective' and `GRASE' mean generally recognized, among
experts qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs, as safe and
effective for use under the conditions prescribed,
recommended, or suggested in the product's labeling, as
described in section 201(p).
``(3) The term `GRASE determination' means, with respect to
a nonprescription sunscreen active ingredient or a
combination of nonprescription sunscreen active ingredients,
a determination of whether such ingredients or combination of
ingredients is generally recognized as safe and effective and
not misbranded for use under the conditions prescribed,
recommended, or suggested in the product's labeling, as
described in section 201(p).
``(4) The term `nonprescription' means not subject to
section 503(b)(1).
``(5) The term `pending request' means each request
submitted to the Secretary--
``(A) for consideration for inclusion in the over-the-
counter drug monograph system;
``(B) that was deemed eligible for such review by
publication of a notice of eligibility in the Federal
Register prior to the date of enactment of the Sunscreen
Innovation Act; and
``(C) for which safety and effectiveness data has been
submitted to the Secretary prior to such date of enactment.
``(6) The term `sponsor' means the person submitting the
request under section 586A(a), including a time and extent
application under section 586B, or the person that submitted
the pending request.
``(7) The term `sunscreen active ingredient' means an
active ingredient that is intended for application to the
skin of humans for purposes of absorbing, reflecting, or
scattering radiation.
``(8) The term `sunscreen' means a product containing one
or more sunscreen active ingredients.
``SEC. 586A. GENERAL PROVISIONS.
``(a) Requests.--Any person may submit a request to the
Secretary for a determination of whether a nonprescription
sunscreen active ingredient or a combination of
nonprescription sunscreen active ingredients, for use under
specified conditions, to be prescribed, recommended, or
suggested in the labeling thereof (including dosage form,
dosage strength, and route of administration) is generally
recognized as safe and effective and not misbranded.
``(b) Rules of Construction.--
``(1) Currently marketed sunscreens.--Nothing in this
subchapter shall be construed to affect the marketing of
sunscreens that are lawfully marketed in the United States on
or before the date of enactment of this subchapter.
``(2) Ensuring safety and effectiveness.--Nothing in this
subchapter shall be construed to alter the Secretary's
authority to prohibit the marketing of a sunscreen that is
not safe and effective or to impose restrictions on the
marketing of a sunscreen to ensure safety and effectiveness.
``(3) Other products.--Nothing in this subchapter shall be
construed to affect the Secretary's regulation of products
other than sunscreens.
``(c) Sunset.--This subchapter shall cease to be effective
at the end of the 5-year period beginning on the date of
enactment of this subchapter.
``SEC. 586B. ELIGIBILITY DETERMINATION.
``(a) In General.--Upon receipt of a request under section
586A(a), not later than 60 days after the date of receipt of
such request, the Secretary shall--
``(1) determine whether the request is eligible for further
review under sections 586C and 586D, as described in
subsection (b);
``(2) notify the sponsor of the Secretary's determination;
and
``(3) make such determination publicly available in
accordance with subsection (c).
``(b) Criteria for Eligibility.--
``(1) In general.--To be eligible for review under sections
586C and 586D, a request shall be for a nonprescription
sunscreen active ingredient or combination of nonprescription
sunscreen active ingredients, for use under specified
conditions, to be prescribed, recommended, or suggested in
the labeling thereof, that--
``(A) is not included in the stayed sunscreen monograph in
part 352 of title 21, Code of Federal Regulations; and
``(B) has been used to a material extent and for a material
time, as described in section 201(p)(2).
``(2) Time and extent application.--A sponsor shall include
in a request under section 586A(a) a time and extent
application including all the information required to meet
the standard described in paragraph (1)(B).
``(c) Public Availability.--
``(1) Redactions for confidential information.--If a
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients is determined to
be eligible for further review under subsection (a)(1), the
Secretary shall make the request publicly available, with
redactions for information that is treated as confidential
under section 552(b) of title 5, United States Code, section
1905 of title 18, United States Code, or section 301(j) of
this Act.
``(2) Identification of confidential information by
sponsor.--Sponsors shall identify any information which the
sponsor considers to be confidential information described in
paragraph (1).
``(3) Confidentiality during eligibility review.--The
information contained in a request under section 586A(a)
shall remain confidential during the Secretary's
consideration under this section of whether the request is
eligible for further review.
``SEC. 586C. DATA SUBMISSION; FILING DETERMINATION.
``(a) In General.--In the case of a request under section
586A(a) that is determined to be eligible under section 586B
for further review under this section and section 586D--
``(1) the Secretary shall, in notifying the public under
section 586B(a)(3) of such eligibility determination, invite
the sponsor of the request and any other interested party to
submit, in support of or otherwise relating to a GRASE
determination--
``(A) published and unpublished data and other information
related to the safety and effectiveness of the
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients for its intended
nonprescription uses; or
``(B) any other comments; and
``(2) not later than 60 days after the submission of such
data and other information by the sponsor, including any
revised submission of such data and other information
following a refusal to file under subparagraph (B), the
Secretary shall--
``(A)(i) issue a written notification to the sponsor
determining that the request under section 586A(a), together
with such data and other information, is sufficiently
complete to conduct a substantive review and make such
notification publicly available; and
``(ii) file such request; or
``(B) issue a written notification to the sponsor refusing
to file the request and stating the reasons for the refusal
and why the data and other information submitted is not
sufficiently complete to conduct a substantive review and
make such notification publicly available;
``(3) the Secretary shall, in filing a request under
paragraph (2)--
``(A) invite the public to submit further comments with
respect to such filing; and
``(B) limit such public comment, and the comment period
under paragraph (1), to the period ending on the date that is
60 days after such filing;
``(4) if the Secretary refuses to file the request--
``(A) the sponsor may, within 30 days of receipt of written
notification of such refusal, seek a meeting with the
Secretary regarding whether the Secretary should file the
request; and
``(B) the Secretary shall convene the meeting; and
``(5) following any such meeting--
``(A) if the sponsor asks that the Secretary file the
request (with or without amendments to correct any purported
deficiencies to the request) the Secretary shall file the
request over protest, issue a written notification of the
filing to the sponsor, and make such notification publicly
available; and
``(B) if the request is so filed over protest, the
Secretary shall not require the sponsor to resubmit a copy of
the request for purposes of such filing.
``(b) Reasons for Refusal to File Request.--The Secretary
may refuse to file a request submitted under section 586A(a)
if the Secretary determines the data or other information
submitted by the sponsor under this section are not
sufficiently complete to conduct a substantive review with
respect to such request.
``(c) Public Availability.--
``(1) Redactions for confidential information.--The
Secretary shall make data and other information submitted in
connection with a request under section 586A(a) publicly
available, with redactions for information that is treated as
confidential under section 552(b) of title 5,
[[Page H6929]]
United States Code, section 1905 of title 18, United States
Code, or section 301(j) of this Act.
``(2) Identification of confidential information by
sponsor.--Sponsors or any other individual submitting data or
other information under this section shall identify any
information which the sponsor or individual considers to be
confidential information described in paragraph (1).
``SEC. 586D. GRASE DETERMINATION.
``(a) Review of New Request.--
``(1) Proposed order by cder.--In the case of a request
under section 586A(a), the Director of the Center for Drug
Evaluation and Research shall--
``(A) not later than 300 days after the date on which the
request is filed under section 586C(a), complete the review
of the request and issue a proposed order determining that--
``(i) the nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active ingredients
that is the subject of the request--
``(I) is GRASE; and
``(II) is not misbranded;
``(ii) the nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active ingredients
that is the subject of the request--
``(I) is not GRASE; or
``(II) is misbranded; or
``(iii) additional information is necessary to allow the
Director of the Center for Drug Evaluation and Research to
complete the review of such request;
``(B) within such 300-day period, convene a meeting of the
Advisory Committee to review the request under section
586A(a): and
``(C) if the Director fails to issue such proposed order
within the 300-day period referred to in subparagraph (A),
transmit the request to the Commissioner of Food and Drugs
for review.
``(2) Proposed order by commissioner.--With respect to a
request transmitted to the Commissioner of Food and Drugs
under paragraph (1)(C), the Commissioner shall, not later
than 60 days after the date of such transmission, issue--
``(A) a proposed order described in paragraph (1)(A)(i);
``(B) a proposed order described in paragraph (1)(A)(ii);
or
``(C) a proposed order described in paragraph (1)(A)(iii).
``(3) Publication in federal register; public comment
period.--A proposed order issued under paragraph (1) or (2)
with respect to a request shall--
``(A) be published in the Federal Register; and
``(B) solicit public comments for a period of not more than
45 days.
``(4) Final order by cder.--In the case of a proposed order
under paragraph (1)(A) or (2) with respect to a request, the
Director of the Center for Drug Evaluation and Research
shall--
``(A) issue a final order with respect to the request--
``(i) in the case of a proposed order under clause (i) or
(ii) of paragraph (1)(A) or subparagraph (A) or (B) of
paragraph (2), not later than 90 days after the end of the
public comment period under paragraph (3)(B); or
``(ii) in the case of a proposed order under paragraph
(1)(A)(iii) or paragraph (2)(C), not later than 210 days
after the date on which the sponsor submits the additional
information requested pursuant to such proposed order; or
``(B) if the Director fails to issue such final order
within such 90- or 210-day period, as applicable, transmit
such proposed order to the Commissioner of Food and Drugs for
review.
``(5) Final order by commissioner.--With respect to a
proposed order transmitted to the Commissioner of Food and
Drugs under paragraph (4)(B), the Commissioner shall issue a
final order with respect to such proposed order not later
than 60 days after the date of such transmission.
``(b) Review of Pending Requests.--
``(1) In general.--The review of a pending request shall be
carried out by the Director of the Center for Drug Evaluation
and Research in accordance with paragraph (3).
``(2) Inapplicability of certain provisions.--Sections 586B
and 586C shall not apply with respect to any pending request.
``(3) Proposed order by cder.--The Director of the Center
for Drug Evaluation and Research shall--
``(A) within the timeframe applicable under paragraph (4),
complete the review of the request and issue a proposed order
determining that--
``(i) the nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active ingredients
that is the subject of the pending request--
``(I) is GRASE; and
``(II) is not misbranded;
``(ii) the nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active ingredients
that is the subject of the pending request--
``(I) is not GRASE; or
``(II) is misbranded; or
``(iii) additional information is necessary to allow the
Director of the Center for Drug Evaluation and Research to
complete the review of the pending request; and
``(B) if the Director fails to issue such proposed order
within the timeframe applicable under paragraph (4), transmit
the pending request to the Commissioner of Food and Drugs for
review.
``(4) Timeframe for issuance of proposed order by cder.--
The Director of the Center for Drug Evaluation and Research
shall issue a proposed order, as required by paragraph
(3)(A)--
``(A) in the case of a pending request for which the Food
and Drug Administration has issued a feedback letter before
the date of enactment of the Sunscreen Innovation Act, not
later than 45 days after such date of enactment; and
``(B) in the case of a pending request for which the Food
and Drug Administration has not issued a feedback letter
before the date of enactment of the Sunscreen Innovation Act,
not later than 90 days after such date of enactment.
``(5) Proposed order by commissioner.--With respect to a
pending request transmitted to the Commissioner of Food and
Drugs under paragraph (3)(B), the Commissioner shall, not
later than 60 days after the date of such transmission,
issue--
``(A) a proposed order described in paragraph (3)(A)(i);
``(B) a proposed order described in paragraph (3)(A)(ii);
or
``(C) a proposed order described in paragraph (3)(A)(iii).
``(6) Publication in federal register; public comment
period.--A proposed order issued under paragraph (3) or (5)
with respect to a pending request shall--
``(A) be published in the Federal Register; and
``(B) solicit public comments for a period of not more than
45 days.
``(7) Advisory committee.--For a proposed order issued
under paragraph (3)(A)(iii) or (5)(C) requesting additional
information, an Advisory Committee meeting shall be convened
if the sponsor requests, or the Director of the Center for
Drug Evaluation and Research or the Commissioner of Food and
Drugs decides, to convene such a meeting for the purpose of
reviewing the pending request.
``(8) Final order by cder.--In the case of a proposed order
under paragraph (3)(A) or (5) with respect to a request, the
Director of the Center for Drug Evaluation and Research
shall--
``(A) issue a final order with respect to the request--
``(i) in the case of a proposed order under clause (i) or
(ii) of paragraph (3)(A) or subparagraph (A) or (B) of
paragraph (5), not later than 90 days after the end of the
public comment period under paragraph (3)(B); or
``(ii) in the case of a proposed order under paragraph
(3)(A)(iii) or paragraph (5)(C)--
``(I) if the Advisory Committee is not convened pursuant to
paragraph (7), not later than 210 days after the date on
which the sponsor submits the additional information
requested pursuant to such proposed order; or
``(II) if the Advisory Committee is convened pursuant to
paragraph (7), not later than 270 days after date on which
the sponsor submits such additional information; or
``(B) if the Director fails to issue such final order
within such 90-, 210-, and 270-day period, as applicable,
transmit such proposed order to the Commissioner of Food and
Drugs for review.
``(9) Final order by commissioner.--With respect to a
proposed order transmitted to the Commissioner of Food and
Drugs under paragraph (8)(B), the Commissioner shall issue a
final order with respect to such proposed order not later
than 60 days after the date of such transmission.
``(c) Advisory Committee.--
``(1) Limitations.--The Food and Drug Administration--
``(A) shall not be required to convene the Advisory
Committee--
``(i) more than once with respect to any request under
section 586A(a) or any pending request; or
``(ii) more than twice in any twelve month period with
respect to the review of submissions under this section; and
``(B) shall not be required to submit more than 3
submissions to the Advisory Committee per meeting.
``(2) Membership.--In appointing the members of the
Advisory Committee, the Secretary may select to serve
temporarily as voting members on the Advisory Committee--
``(A) members of other Federal advisory committees; or
``(B) consultants from outside of the Department of Health
and Human Services who have substantive expertise regarding
sunscreen active ingredients.
``(d) No Delegation.--Any responsibility vested by this
section in the Commissioner of Food and Drugs is not
delegable.
``(e) Effect of Final Order.--
``(1) Content.--A final order under subsection (a)(4),
(a)(5), (b)(8), or (b)(9) with respect to a request under
section 586A(a) or a pending request shall determine that the
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients that is the
subject of the request--
``(A) is GRASE and is not misbranded; or
``(B) is not GRASE or is misbranded.
``(2) Active ingredients determined to be grase.--Upon
issuance of a final order determining that a nonprescription
sunscreen active ingredient or combination of nonprescription
sunscreen active ingredients is GRASE and is not misbranded,
the active ingredient or combination of active ingredients
shall be permitted to be introduced or delivered into
interstate commerce, for use under the conditions subject to
the final order, in accordance with all requirements
applicable to drugs not subject to section 503(b)(1).
``(3) Active ingredients determined not to be grase.--Upon
issuance of a final order determining that the
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients is not GRASE or
is misbranded, the active ingredient or combination of active
ingredients shall not be introduced or delivered into
interstate commerce, for use under the conditions subject to
the final order, unless an application submitted pursuant to
section 505(b) with respect to such active ingredient or
combination of active ingredients is approved.
[[Page H6930]]
``SEC. 586E. REPORTS.
``(a) GAO Report.--Not later than 1 year after the date of
enactment of the Sunscreen Innovation Act, the Comptroller
General of the United States shall--
``(1) submit a report reviewing the overall progress of the
Secretary in carrying out this subchapter to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives; and
``(2) include findings on--
``(A) the progress made in completing the review of pending
requests; and
``(B) the role of the Office of the Commissioner of Food
and Drugs in issuing determinations with respect to pending
requests, including the number of requests transferred to the
Office of the Commissioner under section 586D.
``(b) Secretary's Report.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Sunscreen Innovation Act, and every 2 years
thereafter, the Secretary shall issue a report to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives describing actions taken under this
section. Each report under this subsection shall be posted on
the Internet site of the Food and Drug Administration.
``(2) Contents.--The reports under this subsection shall
include--
``(A) a review of the progress made in issuing GRASE
determinations for pending requests, including the number of
pending requests--
``(i) reviewed and the decision times for each request,
measured from the date of the original request for an
eligibility determination submitted by the sponsor;
``(ii) resulting in a determination that the
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients is GRASE and not
misbranded;
``(iii) resulting in a determination that the
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients is not GRASE and
is 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 request, and the length of time each such
request has been pending, measured from the date of original
request for an eligibility determination by the sponsor;
``(B) a review of the progress made in issuing in a timely
manner GRASE determinations for requests submitted under
section 586A(a), including the number of such requests--
``(i) reviewed and the decision times for each request;
``(ii) resulting in a determination that the
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients is GRASE and not
misbranded;
``(iii) resulting in a determination that the
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients is not GRASE and
is 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 request, and the length of time each such
request has been pending, measured from the date of original
request for an eligibility determination by the sponsor;
``(C) a description of the staffing and resources relating
to the costs associated with the review and decisionmaking
pertaining to requests under this subchapter;
``(D) a review of the progress made in meeting the
deadlines with respect to processing requests under this
subchapter;
``(E) to the extent the Secretary determines appropriate,
recommendations for process improvements in the handling of
pending and new requests, including the advisory committee
review process; and
``(F) recommendations for expanding the applicability of
this subchapter to nonprescription active ingredients that
are not related to the sunscreen category of over-the-counter
drugs.
``(c) Method.--The Secretary shall publish the reports
required under subsection (b) 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.''.
SEC. 3. GUIDANCE.
(a) In General.--
(1) Issuance.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall issue guidance, in accordance with good guidance
practices, on the implementation of, and compliance with,
subchapter I of chapter V of the Federal Food, Drug, and
Cosmetic Act, as added by section 2, including guidance on--
(A) the criteria for determining whether a nonprescription
sunscreen active ingredient or combination of nonprescription
sunscreen active ingredients has been used to a material
extent and for a material time, as described in section
201(p)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(p)(2));
(B) the format and content of a safety and effectiveness
data submission; and
(C) the safety and efficacy standards for determining
whether a nonprescription sunscreen active ingredients or
combination of nonprescription sunscreen active ingredients
is generally recognized as safe and effective, as defined in
section 586 of such subchapter I.
(2) Inapplicability of paperwork reduction act.--Chapter 35
of title 44, United States Code, shall not apply to
collections of information made for purposes of guidance
under this subsection.
(b) Submissions Pending Issuance of Final Guidance.--
Irrespective of whether final guidance under subsection (a)
has been issued--
(1) persons may, beginning on the date of enactment of this
Act, make submissions under subchapter I of chapter V of the
Federal Food, Drug, and Cosmetic Act, as added by section 2;
and
(2) the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall review and
act upon such submissions in accordance with such subchapter.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Kentucky (Mr. Whitfield) and the gentleman from Michigan (Mr. Dingell)
each will control 20 minutes.
The Chair recognizes the gentleman from Kentucky.
General Leave
Mr. WHITFIELD. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and insert extraneous materials on the bill into the Record.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Kentucky?
There was no objection.
Mr. WHITFIELD. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today in support of H.R. 4250, the Sunscreen
Innovation Act, which seeks to address an important area of public
concern by strengthening the sunscreen ingredient review process at the
Food and Drug Administration.
I would like to remind everyone that skin cancer is the most
prevalent kind of cancer in America. Each year, there are more new
cases of skin cancer than breast, prostate, lung, and colon cancer
combined. By 2015, it is estimated that one in 50 Americans will
develop melanoma in their lifetime. Melanoma also happens to be one of
the most common forms of cancer in young adults, particularly young
women.
Even though the Food and Drug Administration has listed action on
sunscreen ingredient applications as a priority since 2008, no new
sunscreen ingredients have been approved by the FDA. In fact, none have
been approved in 15 years. This is despite the fact that eight
sunscreen applications have been pending at the FDA, some as far back
as 2002.
I might add that we find ourselves in this predicament, even though
in Europe and other places around the world, new sunscreen ingredients
are being introduced into sunscreen products.
This past April, the Energy and Commerce Committee held a hearing on
the Sunscreen Innovation Act, where all of the expert witnesses,
including the FDA, were in agreement that the current approval process
is broken and in need of reform.
So the objective of the Sunscreen Innovation Act is twofold: first,
to expedite the review of pending applications at FDA; and, second, to
create a timely and transparent process for new applications to be
reviewed and acted on.
The framework outlined in this legislation strikes an appropriate
balance between consumer safety and access to the very best sunscreen
product. The bill we have before us today reflects a bipartisan
agreement reached in consultation with the Food and Drug Administration
and outside stakeholders, such as the PASS Coalition and Environmental
Working Group.
I want to give a particular thanks to my colleague from Michigan (Mr.
Dingell) for sponsoring this legislation with me. I would also like to
thank Chairman Upton, who worked with us closely throughout the entire
process, and Ranking Member Waxman for their assistance in reaching the
agreement that allowed this legislation to come to the floor.
I urge all my colleagues to support the bill. At this time, I reserve
the balance of my time.
Mr. DINGELL. I yield myself such time as I may consume.
(Mr. DINGELL asked and was given permission to revise and extend his
remarks.)
Mr. DINGELL. Mr. Speaker, I rise in support of H.R. 4250, the
Sunscreen Innovation Act. This legislation proves that this body can
work together, not only across the aisle but with the agencies under
our jurisdiction and also with the industries concerned. This
legislation has the support of everyone.
{time} 1745
There is no opposition to it, and that includes the industry, it
includes the
[[Page H6931]]
health people, it also includes the environmentalists, and it includes
the administration. UV rays from the Sun are, it is understood,
increasing the amount of melanoma amongst our people enormously--800
percent amongst young women, and 400 percent amongst young men over the
past 40 years.
Sunscreens sold in the United States today do not offer the same
level of protection as sunscreen sold in Europe, Canada, Australia, and
other countries. In fact, the last over-the-counter sunscreen
ingredient was approved by FDA in the 1990s. Some sunscreen ingredients
have been waiting review by FDA for over a decade.
This is inexcusable, and it should not be permitted because FDA has
taken so long to review these applications. It is clear that increased
accountability is needed at the agency to ensure these pending
sunscreen applications are reviewed in a timely and speedy manner.
I want to commend and congratulate my colleague, Mr. Whitfield, for
his leadership and fine work on this, and also Chairman Upton for his
outstanding work, and I want to congratulate my friends, Mr. Pallone
and Mr. Waxman, for the good work which they have done on this
legislation.
Indeed, the staffs on both sides of the committee have been
remarkable in what it is they have done on this matter, and it is
interesting to note that we have the strong support of the American
Academy of Dermatology, the American Cancer Society Cancer Action
Network, the Melanoma Research Alliance, the Environmental Working
Group, and the Melanoma Research Foundation.
Mr. Speaker, I insert letters from those agencies into the Record.
American Academy of Dermatology
Association,
Washington, DC, July 21, 2014.
Hon. Ed Whitfield,
U.S. House of Representatives, Washington, DC.
Hon. John Dingell,
U.S. House of Representatives, Washington, DC.
Dear Representative Whitfield and Representative Dingell:
The American Academy of Dermatology Association (Academy),
which represents more than 13,000 dermatologists nationwide,
commends you for working together to amend H.R. 4250, the
Sunscreen Innovation Act, which would ensure that sunscreen
ingredients are reviewed by the U.S. Food and Drug
Administration (FDA) within a predictable timeframe. The
Academy applauds you for your work with stakeholders on this
legislation and is pleased to offer its support for the
Committee-passed amended bill, which has the potential to
reduce Americans' risk for skin cancer by ensuring that they
have access to the safest, most effective sunscreens
available.
Skin cancer is the most common cancer in the United States
and one in five Americans will develop skin cancer in their
lifetime. Dermatologists diagnose more than 3.5 million cases
and treat more than 2.2 million people with skin cancer every
year in the U.S. Research has shown that sunscreen helps
reduce the risk of skin cancer and is essential to protecting
the public from UV radiation. Proper use of sunscreen
combined with access to the safest, most effective
ingredients available will go a long way toward reducing
these statistics.
We applaud you for working together to amend this
legislation, which will ensure that sunscreen ingredients are
thoroughly and expeditiously reviewed in a timely manner. We
support allowing the Nonprescription Drugs Advisory Committee
(NDAC) to provide recommendations on sunscreen ingredients to
the FDA, and are pleased to see a provision under the amended
bill that would allow the Secretary to appoint members of
other federal advisory committees or outside consultants with
substantive expertise regarding sunscreen active ingredients
to the NDAC when sunscreen ingredients are reviewed. We are
also in favor of the provisions within the amended
legislative language that strengthen Congressional oversight
by requiring reporting of FDA's activities and progress in
the review of sunscreen ingredients.
We appreciate your continued leadership on this issue and
look forward to working with you in the fight against skin
cancer. If you have any questions or if we can provide any
additional information, please contact Christine O'Connor,
the Academy's Associate Director, Congressional Policy at
[email protected] or (202) 609-6330; or Niva Haynes, the
Academy's Manager, Congressional Policy at [email protected] or
(202) 712-2608.
Sincerely,
Brett M. Coldiron, MD, FAAD,
President, American Academy of
Dermatology Association.
____
American Cancer Society
Cancer Action Network,
Washington, DC, May 6, 2014.
Re Letter of support for legislation to improve the FDA
process for approving new sunscreen ingredients
Hon. Jack Reed,
U.S. Senate, Washington, DC.
Hon. Ed Whitfield,
U.S. House of Representatives, Washington, DC.
Hon. Johnny Isakson,
U.S. Senate, Washington, DC.
Hon. John Dingell,
U.S. House of Representatives, Washington, DC.
Dear Senator Reed, Senator Isakson, Representative
Whitfield and Representative Dingell, On behalf of the
American Cancer Society Cancer Action Network (ACS CAN), I am
writing to express my support for legislation to reform the
current Food and Drug Administration sunscreen approval
process. ACS CAN is the nonprofit, nonpartisan advocacy
affiliate of the American Cancer Society.
As you know, despite dramatic increases in rates of
melanoma and skin cancer, the last time the FDA approved a
new sunscreen ingredient was during the 1990's. H.R. 4250,
now pending in the House Energy and Commerce Committee,
provides a solid basis for coming to an agreement on a new
and workable FDA review process for approving new sunscreen
ingredients. Ultimately the goal is to provide Americans with
access to the most up-to-date, safe and effective sunscreen
technology now available in Europe while preserving FDA's
important authority to ensure the safety of over the counter
products like sunscreen. The review process in place today
does not work.
We believe that it is important for Americans to have
access to the latest sunscreen technology to help curb the
current skin cancer epidemic in the United States and that is
why ACS CAN has joined the Public Access to SunScreens (PASS)
Coalition. The PASS Coalition is a multi-stakeholder
coalition formed to advocate for a regulatory pathway to
market for new, safe and effective sunscreen ingredients.
Specifically, the purpose of the Coalition is to develop
reforms that guarantee a timely review by the Food & Drug
Administration (FDA) of pending Time and Extent Applications
(TEAs) for over-the-counter (OTC) sunscreen ingredients.
ACS CAN would like to thank you for supporting H.R. 4250,
and we look forward to working with you to resolve any
concerns regarding the legislation so that Americans have
access to the most effective and safe sunscreens.
If you should have any questions or concerns, please do not
hesitate to contact me. Thank you.
Sincerely,
Christopher W. Hansen,
President, American Cancer Society
Cancer Action Network.
____
BASF,
May 5, 2014.
Re Letter of Support for the Sunscreen Innovation Act (S.
2141/H.R. 4250)
Hon. Jack Reed,
U.S. Senate, Washington, DC.
Hon. Johnny Isakson,
U.S. Senate, Washington, DC.
Hon. Ed Whitfield,
U.S. House of Representatives, Washington, DC.
Hon. John Dingell,
U.S. House of Representatives, Washington, DC.
Dear Senator Reed, Senator Isakson, Representative
Whitfield and Representative Dingell: On behalf of BASF
Corporation, I am writing to express support for the
Sunscreen Innovation Act (S. 2141 and H.R. 4250) and thank
you for your leadership on this important issue. BASF
Corporation is the North American affiliate of BASF SE. Our
portfolio includes chemicals, plastics, crop protection
products and performance products. Through science and
innovation, we enable our customers in nearly every industry
to meet the current and future needs of society. We sum up
this contribution in our corporate purpose: We create
chemistry for a sustainable future.
Among the products in BASF's portfolio are sunscreen
filters. BASF is a leading innovator and manufacturer of
sunscreen filters. We currently have three applications for
sunscreen filters pending at the Food and Drug Administration
(FDA)--including one since 2002. These ingredients have been
available to consumers globally since the 1990s. Moreover,
there are additional sunscreen filters we would like to
submit for FDA approval. Given the amount of time the current
applications have been pending, you can understand why it is
important that the current process for consideration of new
sunscreen ingredients needs to be improved.
BASF Corporation supports the Sunscreen Innovation Act
because it creates a transparent and predictable review
process of new sunscreen ingredients and guarantees a
decision by FDA on applications for new ingredients within a
defined timeframe. We believe Americans should have access to
the latest sunscreen technology to help curb the current skin
cancer epidemic in the United States. This is why we joined
the Public Access to SunScreens (PASS) Coalition, a multi-
stakeholder coalition formed to advocate for a regulatory
pathway to market for new, safe and effective sunscreen
ingredients.
[[Page H6932]]
We look forward to working with you to enact this
legislation as expeditiously as possible.
Sincerely,
Steven J. Goldberg,
Vice President and Associate General Counsel, Regulatory and
Government Affairs, BASF Corporation.
____
Melanoma Research Alliance,
Washington, DC, May 2, 2014.
Re Letter of Support for H.R. 4250, the Sunscreen Innovation
Act
Hon. Jack Reed,
U.S. Senate, Washington, DC.
Hon. Ed Whitfield,
U.S. House of Representatives, Washington, DC.
Hon. Johnny Isakson,
U.S. Senate, Washington, DC.
Hon. John Dingell,
U.S. House of Representatives, Washington, DC.
Dear Senator Reed, Senator Isakson, Representative
Whitfield and Representative Dingell: On behalf of the
Melanoma Research Alliance (MRA), I am writing to convey
MRA's support for the Sunscreen Innovation Act (5. 2141 and
H.R. 4250). MRA supports the Sunscreen Innovation Act because
it will reform the current sunscreen approval process and
encourages Congress to enact this critical legislation as
soon as possible.
As you know, despite dramatic increases in rates of
melanoma and skin cancer, the last time the FDA approved a
new sunscreen ingredient is the 1990s. The Sunscreen
Innovation Act will provide Americans access to the latest
sunscreen technology, which addresses America's growing skin
cancer epidemic and fosters innovation in sunscreen. Its
provisions create a transparent and predictable review
process and guarantees that safe and effective products reach
consumers within a defined timeframe.
MRA is a public charity that accelerates the pace of
scientific discovery and its translation in order to
eliminate suffering and death due to melanoma by funding
innovative research programs to improve melanoma prevention,
diagnosis, staging, and treatment. In addition, MRA works
with allies in government, non-profit, and industry to
promote awareness about melanoma among the public.
As you know, in the U.S., one person dies every hour from
melanoma and the numbers of skin cancer cases have risen
dramatically. Sadly, many skin cancers could be prevented
simply by reducing exposure to UV radiation, the leading
environmental factor in the development of skin cancer.
We believe that it is important for Americans to have
access to the latest sunscreen technology to help curb the
current skin cancer epidemic in the United States and that is
why we joined the Public Access to SunScreens (PASS)
Coalition. The PASS Coalition is a multi-stakeholder
coalition formed to advocate for a regulatory pathway to
market for new, safe and effective sunscreen ingredients.
Specifically, the purpose of the Coalition is to develop
reforms that guarantee a timely review by the Food & Drug
Administration (FDA) of pending Time and Extent Applications
(TEAs) for over-the-counter (OTC) sunscreen ingredients.
There is unprecedented opportunity to make a difference in
the future course of melanoma and other skin cancers. We are
especially grateful for your leadership in the fight against
melanoma. Despite recent progress in the field, much more
needs to be done until melanoma prevention is effectively
addressed.
MRA would like to thank you for introducing the Sunscreen
Innovation Act. We look forward to working with you to enact
this legislation this summer.
If you should have any questions or concerns, please do not
hesitate to contact me. Thank you.
Sincerely,
Wendy K.D. Selig,
MRA President and Chief Executive Officer.
____
Melanoma Research Foundation,
Washington, DC, April 29, 2014.
Re Letter of Support for H.R. 4250, the Sunscreen Innovation
Act
Dear Senator Reed, Senator Isakson, Representative
Whitfield and Representative Dingell: On behalf of The
Melanoma Research Foundation (MRF) I am writing to express my
support for the Sunscreen Innovation Act (S. 2141 and H.R.
4250). The MRF supports the Sunscreen Innovation Act because
it will reform the current sunscreen approval process and
encourages Congress to enact this critical legislation as
soon as possible.
As you know, despite dramatic increases in rates of
melanoma and skin cancer, the last time the FDA approved a
new sunscreen ingredient is the 1990s. The Sunscreen
Innovation Act will provide Americans access to the latest
sunscreen technology, which addresses America's growing skin
cancer epidemic and fosters innovation in sunscreen. Its
provisions create a transparent and predictable review
process and guarantees that safe and effective products reach
consumers within a defined timeframe.
The Melanoma Research Foundation (MRF) is the largest
independent organization devoted to melanoma. The MRF is a
501(c) (3) nonprofit organization. Committed to the support
of medical research in finding effective treatments and
eventually a cure for melanoma, the MRF also educates
patients, caregivers and physicians about the prevention,
diagnosis and treatment of melanoma.
Just one blistering sunburn at an early age can double a
person's chance of developing melanoma. Regular use of
sunscreen can greatly reduce the risk. The FDA's inaction
over the past 12 years has prevented consumers from having
access to new sunscreen products that could potentially save
their lives.
We believe that it is important for Americans to have
access to the latest sunscreen technology to help curb the
current skin cancer epidemic in the United States and that is
why we joined the Public Access to SunScreens (PASS)
Coalition. The PASS Coalition is a multi-stakeholder
coalition formed to advocate for a regulatory pathway to
market for new, safe and effective sunscreen ingredients.
Specifically, the purpose of the Coalition is to develop
reforms that guarantee a timely review by the Food & Drug
Administration (FDA) of pending Time and Extent Applications
(TEAs) for over-the-counter (OTC) sunscreen ingredients.
The MRF would you like to thank you for introducing the
Sunscreen Innovation Act. We look forward to working with you
to enact this legislation this summer.
If you should have any questions or concerns, please do not
hesitate to contact me. Thank you.
Sincerely,
Mary Antonucci,
National Director of Advocacy and Volunteer Services, The
Melanoma Research Foundation.
Mr. DINGELL. I would like to observe that the staff has performed
extraordinary work on this matter. I want to congratulate and thank
Greg Sunstrum on my staff, as well as Taylor Booth, John Stone, Carly
McWilliams, and Eric Flamm for their hard work on the legislation, and
I want to recognize members of the PASS Coalition for their hard work
and advocacy on behalf of this important issue.
Mr. Speaker, I reserve the balance of my time.
Mr. WHITFIELD. Mr. Speaker, at this time, I would like to yield 5
minutes to my colleague from Michigan (Mr. Upton), the chairman of the
Energy and Commerce Committee.
Mr. UPTON. Mr. Speaker, I rise today in support of this very
important bipartisan legislation to indeed help protect the public
health. H.R. 4250, the Sunscreen Innovation Act, is just that.
The growing rate of skin cancer in the U.S., including melanoma, is
indeed alarming. According to the American Cancer Society, more
Americans are diagnosed with skin cancer every year than breast,
prostate, lung, and colon cancer combined, and in 2015, this year, one
in every 50 of our constituents is going to be diagnosed with melanoma.
We have got to take every step that we can to combat this public health
crisis.
Sadly, advancements in sunscreen have failed to keep pace with the
increased awareness of the harm overexposure to the Sun can cause. The
FDA has not approved a new nonprescription sunscreen ingredient for
nearly 20 years, despite the fact that several applications have been
pending at the agency for products that have been used safely and
effectively in Europe and other parts of the world.
The review process that these products have to go through at the FDA
is, quite simply, broken. It needs to be fixed, and that is what this
legislation does.
I particularly want to commend the work that my good friend from the
great State of Michigan (Mr. Dingell) and Mr. Whitfield and members of
our entire committee, as this bill passed with unanimous support as we
moved through the process. We wanted to come up with a solution to
allow the FDA to fix the problem, and that is what this bill does.
The Sunscreen Innovation Act is going to address the current backlog
of applications pending at the FDA, as well as establish a predictable
and transparent review process for new applications, incorporating
meaningful input from experts and the public.
The bill also establishes the number of timeframes for decisionmaking
at the FDA and remove administrative hurdles identified by the FDA to
the sunscreen approval process. More importantly, it is going to allow
Americans to benefit from these products sooner, while ensuring that
they are indeed safe and effective.
We have had great success in our Energy and Commerce Committee this
Congress, with over a dozen public health bills that have already been
signed into law, obviously all bipartisan, and I am confident that this
commonsense bill which received, again, unanimous support at our
committee will soon be part of our strong record of results.
In fact, I am told that this is the 61st bill that our committee has
reported
[[Page H6933]]
out that will be approved on the House floor. That is a pretty good
record of achievement.
This one really, like the others, has a real impact on all of our
constituents. It gives the FDA the rightful tools, so that we can get
to the bottom of the problem which impacts one in 50 Americans.
So, again, I want to compliment Mr. Dingell, Mr. Whitfield, Mr.
Pallone, Mr. Waxman, and others for helping deliver this bill to the
House floor, and I look forward to a strong vote--hopefully voice--in a
few minutes.
Mr. DINGELL. Mr. Speaker, I have no further requests for time, so if
the gentleman, my good friend, Mr. Whitfield, is ready, I am prepared
to yield back with the strong urging to my colleagues to support this
bill--which is strongly bipartisan--unanimously brought forward to the
Congress and which has the strong support of both industry, government,
and health groups.
Mr. Speaker, I yield back the balance of my time.
Mr. WHITFIELD. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I want to, once again, thank Mr. Dingell, and I
appreciate his naming the staff because there was a lot of negotiations
with FDA on this bill, and Taylor Booth on my staff and other members
of the Energy and Commerce Committee staff, as named by Mr. Dingell, I
want to give special thanks to them, and also, we appreciate the
efforts of Mr. Pitts, who is the chairman of the Health Subcommittee.
Without the help of him, Mr. Pallone, and their staffs, we would not
have been able to bring this bill to the floor. So I would urge
everyone to support it, and with that, I yield back the balance of my
time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Kentucky (Mr. Whitfield) that the House suspend the
rules and pass the bill, H.R. 4250, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
____________________