[Congressional Record Volume 164, Number 119 (Monday, July 16, 2018)]
[House]
[Pages H6227-H6237]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION, AND REFORM ACT OF 2018
Mr. LATTA. Mr. Speaker, I move to suspend the rules and pass the bill
(H.R. 5333) to amend the Federal Food, Drug, and Cosmetic Act to
clarify the regulatory framework with respect to certain
nonprescription drugs that are marketed without an approved new drug
application, and for other purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 5333
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 ``Over-the-Counter Monograph
Safety, Innovation, and Reform Act of 2018''.
TITLE I--OTC DRUG REVIEW
SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT
ARE MARKETED WITHOUT AN APPROVED NEW DRUG
APPLICATION.
(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act is amended by inserting after section 505F of
such Act (21 U.S.C. 355g) the following:
``SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT
ARE MARKETED WITHOUT AN APPROVED NEW DRUG
APPLICATION.
``(a) Nonprescription Drugs Marketed Without an Approved
Application.--Nonprescription drugs marketed without an
approved new drug application under section 505, as of the
date of the enactment of the Over-the-Counter Monograph
Safety, Innovation, and Reform Act of 2018, shall be treated
in accordance with this subsection.
``(1) Drugs subject to a final monograph; category i drugs
subject to a tentative final monograph.--A drug is deemed to
be generally recognized as safe and effective within the
meaning of section 201(p)(1), not a new drug under section
201(p), and not subject to section 503(b)(1), if--
``(A) the drug is--
``(i) in conformity with the requirements for
nonprescription use of a final monograph issued under part
330 of title 21, Code of Federal Regulations (except as
provided in paragraph (2)), the general requirements for
nonprescription drugs, and requirements under subsections
(b), (c), and (k); and
``(ii) except as permitted by an order issued under
subsection (b) or, in the case of a minor change in the drug,
in conformity with an order issued under subsection (c), in a
dosage form that, immediately prior to the date of the
enactment of this section, has been used to a material extent
and for a material time within the meaning of section
201(p)(2); or
``(B) the drug is--
``(i) classified in category I for safety and effectiveness
under a tentative final monograph that is the most recently
applicable proposal or determination issued under part 330 of
title 21, Code of Federal Regulations;
``(ii) in conformity with the proposed requirements for
nonprescription use of such tentative final monograph, any
applicable subsequent determination by the Secretary, the
general requirements for nonprescription drugs, and
requirements under subsections (b), (c), and (k); and
``(iii) except as permitted by an order issued under
subsection (b) or, in the case of a minor change in the drug,
in conformity with an order issued under subsection (c), in a
dosage form that, immediately prior to the date of the
enactment of this section, has been used to a material extent
and for a material time within the meaning of section
201(p)(2).
``(2) Treatment of sunscreen drugs.--With respect to
sunscreen drugs subject to this section, the applicable
requirements shall be the requirements specified in part 352
of title 21, Code of Federal Regulations, as published on May
21, 1999, beginning on page 27687 of volume 64 of the Federal
Register, except that the applicable requirements governing
effectiveness and labeling shall be those specified in
section 201.327 of title 21, Code of Federal Regulations,
subject to the requirements of subsections (b), (c), and (k).
``(3) Category iii drugs subject to a tentative final
monograph; category i drugs subject to proposed monograph or
advance notice of proposed rulemaking.--A drug that is not
described in paragraphs (1), (2), or (4) is not required to
be the subject of an application approved under section 505,
and is not subject to section 503(b)(1), if--
``(A) the drug is--
``(i) classified in category III for safety or
effectiveness in the preamble of a proposed rule establishing
a tentative final monograph that is the most recently
applicable proposal or determination for such drug issued
under part 330 of title 21, Code of Federal Regulations;
``(ii) in conformity with--
``(I) the conditions of use, including indication and
dosage strength, if any, described for such category III drug
in such preamble or in an applicable subsequent proposed
rule;
``(II) the proposed requirements for drugs classified in
such tentative final monograph in category I in the most
recently proposed rule establishing requirements related to
such tentative final monograph and in any final rule
establishing requirements that are applicable to the drug;
and
[[Page H6228]]
``(III) the general requirements for nonprescription drugs
and requirements under subsections (b) or (k); and
``(iii) in a dosage form that, immediately prior to the
date of the enactment of this section, was not required to
have satisfied the requirements of section 330.14 of title
21, Code of Federal Regulations (as in effect at that time),
in order for such drug to be lawfully marketed without an
application approved under section 505; or
``(B) the drug is--
``(i) classified in category I for safety and effectiveness
under a proposed monograph or advance notice of proposed
rulemaking that is the most recently applicable proposal or
determination for such drug issued under part 330 of title
21, Code of Federal Regulations;
``(ii) in conformity with the requirements for
nonprescription use of such proposed monograph or advance
notice of proposed rulemaking, any applicable subsequent
determination by the Secretary, the general requirements for
nonprescription drugs, and requirements under subsections (b)
or (k); and
``(iii) in a dosage form that, immediately prior to the
date of the enactment of this section, has been used to a
material extent and for a material time within the meaning of
section 201(p)(2).
``(4) Category ii drugs deemed new drugs.--A drug that is
classified in category II for safety or effectiveness under a
tentative final monograph or that is subject to a
determination to be not safe or effective in a proposed rule
that is the most recently applicable proposal issued under
part 330 of title 21, Code of Federal Regulations, shall be
deemed to be a new drug within the meaning of section 201(p),
misbranded under section 502(ee), and subject to the
requirement for an approved new drug application under
section 505 beginning on the day that is 180 calendar days
after the date of the enactment of this section, unless,
before such day, the Secretary determines that it is in the
interest of public health to extend the period during which
the drug may be marketed without such an approved new drug
application.
``(5) Drugs not grase deemed new drugs.--A drug that the
Secretary has determined not to be generally recognized as
safe and effective within the meaning of section 201(p)(1)
under a final determination issued under part 330 of title
21, Code of Federal Regulations, shall be deemed to be a new
drug within the meaning of section 201(p), misbranded under
section 502(ee), and subject to the requirement for an
approved new drug application under section 505.
``(6) Other drugs deemed new drugs.--Except as provided in
subsection (m), a drug is deemed to be a new drug within the
meaning of section 201(p) and misbranded under section
502(ee) if the drug--
``(A) is not subject to section 503(b)(1); and
``(B) is not described in paragraphs (1), (2), (3), (4), or
(5), or subsection (b)(1)(B).
``(b) Administrative Orders.--
``(1) In general.--
``(A) Determination.--The Secretary may, on the initiative
of the Secretary or at the request of one or more requestors,
issue administrative orders determining whether there are
conditions under which specific drugs, classes of such drugs,
or combinations of such drugs are determined to be--
``(i) not subject to section 503(b)(1); and
``(ii) generally recognized as safe and effective within
the meaning of section 201(p)(1).
``(B) Effect.--A drug or combination of drugs shall be
deemed to not require approval under section 505 if such drug
or combination of drugs--
``(i) is determined by the Secretary to meet the conditions
specified in clauses (i) and (ii) of subparagraph (A);
``(ii) is marketed in conformity with an administrative
order under this subsection;
``(iii) meets the general requirements for nonprescription
drugs; and
``(iv) meets the requirements under subsections (c) and
(k).
``(C) Standard.--The Secretary shall find that a drug is
not generally recognized as safe and effective within the
meaning of section 201(p)(1) if--
``(i) the evidence shows that the drug is not generally
recognized as safe and effective within the meaning of
section 201(p)(1); or
``(ii) the evidence is inadequate to show that the drug is
generally recognized as safe and effective within the meaning
of section 201(p)(1).
``(2) Administrative orders initiated by the secretary.--
``(A) In general.--In issuing an administrative order under
paragraph (1) upon the Secretary's initiative, the Secretary
shall--
``(i) make reasonable efforts to notify informally, not
later than 2 business days before the issuance of the
proposed order, the sponsors of drugs who have a listing in
effect under section 510(j) for the drugs or combination of
drugs that will be subject to the administrative order;
``(ii) after any such reasonable efforts of notification--
``(I) issue a proposed administrative order by publishing
it on the website of the Food and Drug Administration and
include in such order the reasons for the issuance of such
order; and
``(II) publish a notice of availability of such proposed
order in the Federal Register;
``(iii) except as provided in subparagraph (B), provide for
a public comment period with respect to such proposed order
of not less than 45 calendar days; and
``(iv) if, after completion of the proceedings specified in
clauses (i) through (iii), the Secretary determines that it
is appropriate to issue a final administrative order--
``(I) issue the final administrative order, together with a
detailed statement of reasons, which order shall not take
effect until the time for requesting judicial review under
paragraph (3)(D)(ii) has expired;
``(II) publish a notice of such final administrative order
in the Federal Register;
``(III) afford requestors of drugs that will be subject to
such order the opportunity for formal dispute resolution up
to the level of the Director of the Center for Drug
Evaluation and Research, which initially must be requested
within 45 calendar days of the issuance of the order, and,
for subsequent levels of appeal, within 30 calendar days of
the prior decision; and
``(IV) except with respect to drugs described in paragraph
(3)(B), upon completion of the formal dispute resolution
procedure, inform the persons which sought such dispute
resolution of their right to request a hearing.
``(B) Exceptions.--When issuing an administrative order
under paragraph (1) on the Secretary's initiative proposing
to determine that a drug described in subsection (a)(3) is
not generally recognized as safe and effective within the
meaning of section 201(p)(1), the Secretary shall follow the
procedures in subparagraph (A), except that--
``(i) the proposed order shall include notice of--
``(I) the general categories of data the Secretary has
determined necessary to establish that the drug is generally
recognized as safe and effective within the meaning of
section 201(p)(1); and
``(II) the format for submissions by interested persons;
``(ii) the Secretary shall provide for a public comment
period of no less than 180 calendar days with respect to such
proposed order, except when the Secretary determines, for
good cause, that a shorter period is in the interests of
public health; and
``(iii) any person who submits data in such comment period
shall include a certification that the person has submitted
all evidence created, obtained, or received by that person
that is both within the categories of data identified in the
proposed order and relevant to a determination as to whether
the drug is generally recognized as safe and effective within
the meaning of section 201(p)(1).
``(3) Hearings; judicial review.--
``(A) In general.--Only a person who participated in each
stage of formal dispute resolution under subclause (III) of
paragraph (2)(A)(iv) of an administrative order with respect
to a drug may request a hearing concerning a final
administrative order issued under such paragraph with respect
to such drug. Such person must submit a request for a
hearing, which shall be based solely on information in the
administrative record, to the Secretary not later than 30
calendar days after receiving notice of the final decision of
the formal dispute resolution procedure.
``(B) No hearing required with respect to orders relating
to certain drugs.--
``(i) In general.--The Secretary shall not be required to
provide notice and an opportunity for a hearing pursuant to
paragraph (2)(A)(iv) if the final administrative order
involved relates to a drug--
``(I) that is described in subsection (a)(3)(A); and
``(II) with respect to which no human or non-human data
studies relevant to the safety or effectiveness of such drug
have been submitted to the administrative record since the
issuance of the most recent tentative final monograph
relating to such drug.
``(ii) Human data studies and non-human data defined.--In
this subparagraph:
``(I) The term `human data studies' means clinical trials
of safety or effectiveness (including actual use studies),
pharmacokinetics studies, or bioavailability studies.
``(II) The term `non-human data' means data from testing
other than with human subjects which provides information
concerning safety or effectiveness.
``(C) Hearing procedures.--
``(i) Denial of request for hearing.--If the Secretary
determines that information submitted in a request for a
hearing under subparagraph (A) with respect to a final
administrative order issued under paragraph (2)(A)(iv), does
not identify the existence of a genuine and substantial
question of material fact, the Secretary may deny such
request. In making such a determination, the Secretary may
consider only information and data that are based on relevant
and reliable scientific principles and methodologies.
``(ii) Single hearing for multiple related requests.--If
more than one request for a hearing is submitted with respect
to the same administrative order under subparagraph (A), the
Secretary may direct that a single hearing be conducted in
which all persons whose hearing requests were granted may
participate.
``(iii) Presiding officer.--The presiding officer of a
hearing requested under subparagraph (A) shall--
``(I) be designated by the Secretary;
``(II) not be an employee of the Center for Drug Evaluation
and Research; and
``(III) not have been previously involved in the
development of the administrative order involved or
proceedings relating to that administrative order.
``(iv) Rights of parties to hearing.--The parties to a
hearing requested under subparagraph (A) shall have the right
to present testimony, including testimony of expert
witnesses, and to cross-examine witnesses presented by other
parties. Where appropriate, the presiding officer may require
that cross-examination by parties representing substantially
the same interests be consolidated to promote efficiency and
avoid duplication.
``(v) Final decision.--
``(I) At the conclusion of a hearing requested under
subparagraph (A), the presiding officer of the hearing shall
issue a decision containing findings of fact and conclusions
of law. The decision of the presiding officer shall be final.
``(II) The final decision may not take effect until the
period under subparagraph (D)(ii) for submitting a request
for judicial review of such decision expires.
[[Page H6229]]
``(D) Judicial review of final administrative order.--
``(i) In general.--The procedures described in section
505(h) shall apply with respect to judicial review of final
administrative orders issued under this subsection in the
same manner and to the same extent as such section applies to
an order described in such section except that the judicial
review shall be taken by filing in an appropriate district
court of the United States in lieu of the appellate courts
specified in such section.
``(ii) Period to submit a request for judicial review.--A
person eligible to request a hearing under this paragraph and
seeking judicial review of a final administrative order
issued under this subsection shall file such request for
judicial review not later than 60 calendar days after the
latest of--
``(I) the date on which notice of such order is published;
``(II) the date on which a hearing with respect to such
order is denied under subparagraph (B) or (C)(i);
``(III) the date on which a final decision is made
following a hearing under subparagraph (C)(v); or
``(IV) if no hearing is requested, the date on which the
time for requesting a hearing expires.
``(4) Expedited procedure with respect to administrative
orders initiated by the secretary.--
``(A) Imminent hazard to the public health.--
``(i) In general.--In the case of a determination by the
Secretary that a drug, class of drugs, or combination of
drugs subject to this section poses an imminent hazard to the
public health, the Secretary, after first making reasonable
efforts to notify, not later than 48 hours before issuance of
such order under this subparagraph, sponsors who have a
listing in effect under section 510(j) for such drug or
combination of drugs--
``(I) may issue an interim final administrative order for
such drug, class of drugs, or combination of drugs under
paragraph (1), together with a detailed statement of the
reasons for such order;
``(II) shall publish in the Federal Register a notice of
availability of any such order; and
``(III) shall provide for a public comment period of at
least 45 calendar days with respect to such interim final
order.
``(ii) Nondelegation.--The Secretary may not delegate the
authority to issue an interim final administrative order
under this subparagraph.
``(B) Safety labeling changes.--
``(i) In general.--In the case of a determination by the
Secretary that a change in the labeling of a drug, class of
drugs, or combination of drugs subject to this section is
reasonably expected to mitigate a significant or unreasonable
risk of a serious adverse event associated with use of the
drug, the Secretary may--
``(I) make reasonable efforts to notify informally, not
later than 48 hours before the issuance of the interim final
order, the sponsors of drugs who have a listing in effect
under section 510(j) for such drug or combination of drugs;
``(II) after reasonable efforts of notification, issue an
interim final administrative order in accordance with
paragraph (1) to require such change, together with a
detailed statement of the reasons for such order;
``(III) publish in the Federal Register a notice of
availability of such order; and
``(IV) provide for a public comment period of at least 45
calendar days with respect to such interim final order.
``(ii) Content of order.--An interim final order issued
under this subparagraph with respect to the labeling of a
drug may provide for new warnings and other information
required for safe use of the drug.
``(C) Effective date.--An order under subparagraph (A) or
(B) shall take effect on a date specified by the Secretary.
``(D) Final order.--After the completion of the proceedings
in subparagraph (A) or (B), the Secretary shall--
``(i) issue a final order in accordance with paragraph (1);
``(ii) publish a notice of availability of such final
administrative order in the Federal Register; and
``(iii) afford sponsors of such drugs that will be subject
to such an order the opportunity for formal dispute
resolution up to the level of the Director of the Center for
Drug Evaluation and Research, which must initially be within
45 calendar days of the issuance of the order, and for
subsequent levels of appeal, within 30 calendar days of the
prior decision.
``(E) Hearings.--A sponsor of a drug subject to a final
order issued under subparagraph (D) and that participated in
each stage of formal dispute resolution under clause (iii) of
such subparagraph may request a hearing on such order. The
provisions of subparagraphs (A), (B), and (C) of paragraph
(3), other than paragraph (3)(C)(v)(II), shall apply with
respect to a hearing on such order in the same manner and to
the same extent as such provisions apply with respect to a
hearing on an administrative order issued under paragraph
(2)(A)(iv).
``(F) Timing.--
``(i) Final order and hearing.--The Secretary shall--
``(I) not later than 6 months after the date on which the
comment period closes under subparagraph (A) or (B), issue a
final order in accordance with paragraph (1); and
``(II) not later than 12 months after the date on which
such final order is issued, complete any hearing under
subparagraph (E).
``(ii) Dispute resolution request.--The Secretary shall
specify in an interim final order issued under subparagraph
(A) or (B) such shorter periods for requesting dispute
resolution under subparagraph (D)(iii) as are necessary to
meet the requirements of this subparagraph.
``(G) Judicial review.--A final order issued pursuant to
subparagraph (F) shall be subject to judicial review in
accordance with paragraph (3)(D).
``(5) Administrative order initiated at the request of a
requestor.--
``(A) In general.--In issuing an administrative order under
paragraph (1) at the request of a requestor with respect to
certain drugs, classes of drugs, or combinations of drugs--
``(i) the Secretary shall, after receiving a request under
this subparagraph, determine whether the request is
sufficiently complete and formatted to permit a substantive
review;
``(ii) if the Secretary determines that the request is
sufficiently complete and formatted to permit a substantive
review, the Secretary shall--
``(I) file the request; and
``(II) initiate proceedings with respect to issuing an
administrative order in accordance with paragraphs (2) and
(3); and
``(iii) except as provided in paragraph (6), if the
Secretary determines that a request does not meet the
requirements for filing or is not sufficiently complete and
formatted to permit a substantive review, the requestor may
demand that the request be filed over protest, and the
Secretary shall initiate proceedings to review the request in
accordance with paragraph (2)(A).
``(B) Request to initiate proceedings.--
``(i) In general.--A requestor seeking an administrative
order under paragraph (1) with respect to certain drugs,
classes of drugs, or combinations of drugs, shall submit to
the Secretary a request to initiate proceedings for such
order in the form and manner as specified by the Secretary.
Such requestor may submit a request under this subparagraph
for the issuance of an administrative order--
``(I) determining whether a drug is generally recognized as
safe and effective within the meaning of section 201(p)(1),
exempt from section 503(b)(1), and not required to be the
subject of an approved application under section 505; or
``(II) determining whether a change to a condition of use
of a drug is generally recognized as safe and effective
within the meaning of section 201(p)(1), exempt from section
503(b)(1), and not required to be the subject of an approved
application under section 505, if, absent such a changed
condition of use, such drug is--
``(aa) generally recognized as safe and effective within
the meaning of section 201(p)(1) in accordance with
subsection (a)(1), (a)(2), or an order under this subsection;
or
``(bb) subject to subsection (a)(3), but only if such
requestor initiates such request in conjunction with a
request for the Secretary to determine whether such drug is
generally recognized as safe and effective within the meaning
of section 201(p)(1), which is filed by the Secretary under
subparagraph (A)(ii).
``(ii) Exception.--The Secretary is not required to
complete review of a request for a change described in clause
(i)(II) if the Secretary determines that there is an
inadequate basis to find the drug is generally recognized as
safe and effective within the meaning of section 201(p)(1)
under paragraph (1) and issues a final order announcing that
determination.
``(iii) Withdrawal.--The requestor may withdraw a request
under this paragraph, according to the procedures set forth
pursuant to subsection (d)(2)(B). Notwithstanding any other
provision of this section, if such request is withdrawn, the
Secretary may cease proceedings under this subparagraph.
``(C) Exclusivity.--
``(i) In general.--A final administrative order issued in
response to a request under this section shall have the
effect of authorizing solely the order requestor (or the
licensees, assignees, or successors in interest of such
requestor with respect to the subject of such order), for a
period of 18 months following the effective date of such
final order, to market drugs--
``(I) incorporating changes described in clause (ii);
``(II) beginning on the date the requestor (or any such
licensees, assignees, or successors in interest) may lawfully
market such drugs pursuant to the order; and
``(III) subject to the limitations under clause (iv).
``(ii) Changes described.--A change described in this
clause is a change subject to an order specified in clause
(i), which--
``(I) provides for a drug to contain an active ingredient
(including any ester or salt of the active ingredient) not
previously incorporated in a drug described in clause (iii);
or
``(II) provides for a change in the conditions of use of a
drug, for which new human data studies conducted or sponsored
by the requestor (or for which the requestor has an exclusive
right of reference) were essential to the issuance of such
order.
``(iii) Drugs described.--The drugs described in this
clause are drugs--
``(I) specified in subsection (a)(1), (a)(2), or (a)(3);
``(II) subject to a final order issued under this section;
``(III) subject to a final sunscreen order (as defined in
section 586(2)(A)); or
``(IV) described in subsection (m)(1), other than drugs
subject to an active enforcement action under chapter III of
this Act.
``(iv) Limitations on exclusivity.--
``(I) In general.--Only one period of exclusivity shall be
granted, under each order described in clause (i), with
respect to changes (to the drug subject to such order) which
are either--
``(aa) changes described in clause (ii)(I), relating to
active ingredients; or
``(bb) changes described in clause (ii)(II), relating to
conditions of use.
``(II) No exclusivity allowed.--No exclusivity shall apply
to changes to a drug which are--
``(aa) the subject of a Tier 2 OTC monograph order request
(as defined in section 744N);
[[Page H6230]]
``(bb) safety-related changes, as defined by the Secretary,
or any other changes the Secretary considers necessary to
assure safe use; or
``(cc) changes related to methods of testing safety or
efficacy.
``(v) New human data studies defined.--In this
subparagraph, the term `new human data studies' means
clinical trials of safety or effectiveness (including actual
use studies), pharmacokinetics studies, or bioavailability
studies, the results of which--
``(I) have not been relied on by the Secretary to support--
``(aa) a proposed or final determination that a drug
described in subclauses (I), (II), or (III) of clause (iii)
is generally recognized as safe and effective within the
meaning of section 201(p)(1); or
``(bb) approval of a drug that was approved under section
505; and
``(II) do not duplicate the results of another study that
was relied on by the Secretary to support--
``(aa) a proposed or final determination that a drug
described in subclauses (I), (II), or (III) of clause (iii)
is generally recognized as safe and effective within the
meaning of section 201(p)(1); or
``(bb) approval of a drug that was approved under section
505.
``(vi) Effective date.--A final order subject to clause (i)
shall take effect on the date when the order requestor (or
the licensees, assignees, or successors in interest of such
requestor with respect to such order) submits updated drug
listing information under subsection (e) with respect to the
change which is permitted under such order.
``(vii) GAO study.--Not later than 4 years after the date
of enactment of the Over-the-Counter Monograph, Safety,
Innovation, and Reform Act of 2018, the Comptroller General
of the United States shall submit a study to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate addressing the effectiveness and overall impact of
exclusivity under this section, including its impact on
consumer access. Such study shall include--
``(I) the number of nonprescription drug products that were
granted exclusivity and the indication for which the
nonprescription drug products were determined to be generally
recognized as safe and effective;
``(II) whether the exclusivity for such drug products was
granted for--
``(aa) a new active ingredient (including any ester or salt
of the active ingredient); or
``(bb) changes in the conditions of use of a drug, for
which new human data studies conducted or sponsored by the
requestor were essential;
``(III) whether, and to what extent, the exclusivity
impacted the requestor's or sponsor's decision to develop the
drug product;
``(IV) an analysis of the implementation of the exclusivity
provision in this subparagraph, including--
``(aa) the resources used by the Food and Drug
Administration;
``(bb) the impact of such provision on innovation, as well
as research and development in the nonprescription drug
market;
``(cc) the impact of such provision on competition in the
nonprescription drug market;
``(dd) the impact of such provision on consumer access to
nonprescription drug products;
``(ee) the impact of such provision on the prices of
nonprescription drug products; and
``(ff) whether the administrative orders initiated by
requestors under this section have been sufficient to
encourage the development of nonprescription drug products
that would likely not be otherwise developed, or developed in
as timely a manner; and
``(V) whether the administrative orders initiated by
requestors under this section have been sufficient incentive
to encourage innovation in the nonprescription drug market.
``(6) Information regarding safe nonprescription marketing
and use as condition for filing a generally recognized as
safe and effective request.--
``(A) In general.--In response to a request under this
section that a drug described in subparagraph (B) be
generally recognized as safe and effective, the Secretary--
``(i) may file such request, if the request includes
information specified under subparagraph (C) with respect to
safe nonprescription marketing and use of such drug; or
``(ii) if the request fails to include information
specified under subparagraph (C), shall refuse to file such
request and require that nonprescription marketing of the
drug be pursuant to a new drug application as described in
subparagraph (D).
``(B) Drug described.--A drug described in this
subparagraph is a nonprescription drug which contains an
active ingredient not previously incorporated in a drug--
``(i) specified in subsection (a)(1), (a)(2), or (a)(3);
``(ii) subject to a final order under this section; or
``(iii) subject to a final sunscreen order (as defined in
section 586(2)(A)).
``(C) Information demonstrating prima facie safe
nonprescription marketing and use.--Information specified in
this subparagraph, with respect to a request described in
subparagraph (A)(i), is--
``(i) information sufficient for a prima facie
demonstration that the drug subject to such request has a
verifiable history of being marketed and safely used by
consumers in the United States as a nonprescription drug
under comparable conditions of use;
``(ii) if the drug has not been previously marketed in the
United States as a nonprescription drug, information
sufficient for a prima facie demonstration that the drug was
marketed and safely used under comparable conditions of
marketing and use in a country listed in section 802(b)(1)(A)
or designated by the Secretary in accordance with section
802(b)(1)(B)--
``(I) for such period of time as needed to provide
reasonable assurances concerning the safe nonprescription use
of the drug; and
``(II) during such time was subject to sufficient
monitoring by a regulatory body considered acceptable by the
Secretary for such monitoring purposes, including for adverse
events associated with nonprescription use of the drug; or
``(iii) if the Secretary determines that information
described in clauses (i) or (ii) is not needed to provide a
prima facie demonstration that the drug can be safely
marketed and used as a nonprescription drug, such other
information the Secretary determines is sufficient for such
purposes.
``(D) Marketing pursuant to new drug application.--In the
case of a request described in subparagraph (A)(ii), the drug
subject to such request may be re-submitted for filing only
if--
``(i) the drug is marketed as a nonprescription drug, under
conditions of use comparable to the conditions specified in
the request, for such period of time as the Secretary
determines appropriate (not to exceed five consecutive years)
pursuant to an application approved under section 505; and
``(ii) during such time period, one million retail packages
of the drug, or an equivalent quantity as determined by the
Secretary, were distributed for retail sale, as determined in
such manner as the Secretary finds appropriate.
``(E) Rule of application.--Except in the case of a request
involving a drug described in section 586(9), as in effect on
January 1, 2017, if the Secretary refuses to file a request
under this paragraph, the requestor may not file such request
over protest under paragraph (5)(A)(iii).
``(7) Packaging.--An administrative order issued under
paragraph (2), (4)(A), or (5) may include requirements for
the packaging of a drug to encourage use in accordance with
labeling. Such requirements may include unit dose packaging,
requirements for products intended for use by children,
requirements to reduce risk of harm from unsupervised
ingestion, and other appropriate requirements. This paragraph
does not authorize the Food and Drug Administration to
require standards or testing procedures as described in part
1700 of title 16, Code of Federal Regulations.
``(8) Final and tentative final monographs for category i
drugs deemed final administrative orders.--
``(A) In general.--A final monograph or tentative final
monograph described in subparagraph (B) shall be deemed to be
a final administrative order under this subsection and may be
amended, revoked, or otherwise modified in accordance with
the procedures of this subsection.
``(B) Monographs described.--For purposes of subparagraph
(A), a final monograph or tentative final monograph is
described in this subparagraph if it--
``(i) establishes conditions of use for a drug described in
paragraph (1) or (2) of subsection (a); and
``(ii) represents the most recently promulgated version of
such conditions, including as modified, in whole or in part,
by any proposed or final rule.
``(C) Deemed orders include harmonizing technical
amendments.--The deemed establishment of a final
administrative order under subparagraph (A) shall be
construed to include any technical amendments to such order
as the Secretary determines necessary to ensure that such
order is appropriately harmonized, in terms of terminology or
cross-references, with the applicable provisions of this Act
(and regulations thereunder) and any other orders issued
under this section.
``(c) Procedure for Minor Changes.--
``(1) In general.--Minor changes in the dosage form of a
drug that is described in paragraph (1) or (2) of subsection
(a) or the subject of an order issued under subsection (b)
may be made by a requestor without the issuance of an order
under subsection (b) if--
``(A) the requestor maintains such information as is
necessary to demonstrate that the change--
``(i) will not affect the safety or effectiveness of the
drug; and
``(ii) will not materially affect the extent of absorption
or other exposure to the active ingredient in comparison to a
suitable reference product; and
``(B) the change is in conformity with the requirements of
an applicable administrative order issued by the Secretary
under paragraph (3).
``(2) Additional information.--
``(A) Access to records.--A sponsor shall submit records
requested by the Secretary relating to such a minor change
under section 704(a)(4), within 15 business days of receiving
such a request, or such longer period as the Secretary may
provide.
``(B) Insufficient information.--If the Secretary
determines that the information contained in such records is
not sufficient to demonstrate that the change does not affect
the safety or effectiveness of the drug or materially affect
the extent of absorption or other exposure to the active
ingredient, the Secretary--
``(i) may so inform the sponsor of the drug in writing; and
``(ii) provide the sponsor of the drug with a reasonable
opportunity to provide additional information.
``(C) Failure to submit sufficient information.--If the
sponsor fails to provide such additional information within
the prescribed time, or if the Secretary determines that such
additional information does not demonstrate that the change
does not affect the safety or effectiveness of the drug or
materially affect the extent of absorption or other exposure
to the active ingredient, the drug as modified is a new drug
[[Page H6231]]
within the meaning of section 201(p) and shall be deemed to
be misbranded under section 502(ee).
``(3) Determining whether a change will affect safety or
effectiveness.--
``(A) In general.--The Secretary shall issue one or more
administrative orders specifying requirements for determining
whether a minor change made by a sponsor pursuant to this
subsection will affect the safety or effectiveness of a drug
or materially affect the extent of absorption or other
exposure to an active ingredient in the drug in comparison to
a suitable reference product, together with guidance for
applying those orders to specific dosage forms.
``(B) Standard practices.--The orders and guidance issued
by the Secretary under subparagraph (A) shall take into
account relevant public standards and standard practices for
evaluating the quality of drugs, and may take into account
the special needs of populations, including children.
``(d) Confidentiality of Information Submitted to the
Secretary.--
``(1) In general.--Subject to paragraph (2), any
information, including reports of testing conducted on the
drug or drugs involved, that is submitted by a requestor in
connection with proceedings on an order under this section
(including any minor change under subsection (c)) and is a
trade secret or confidential information subject to section
552(b)(4) of title 5, United States Code, or section 1905 of
title 18, United States Code, shall not be disclosed to the
public unless the requestor consents to that disclosure.
``(2) Public availability.--
``(A) In general.--Except as provided in subparagraph (B),
the Secretary shall--
``(i) make any information submitted by a requestor in
support of a request under subsection (b)(5)(A) available to
the public not later than the date on which the proposed
order is issued; and
``(ii) make any information submitted by any other person
with respect to an order requested (or initiated by the
Secretary) under subsection (b), available to the public upon
such submission.
``(B) Limitations on public availability.--Information
described in subparagraph (A) shall not be made public if--
``(i) the information pertains to pharmaceutical quality
information, unless such information is necessary to
establish standards under which a drug is generally
recognized as safe and effective within the meaning of
section 201(p)(1);
``(ii) the information is submitted in a requestor-
initiated request, but the requestor withdraws such request,
in accordance with withdrawal procedures established by the
Secretary, before the Secretary issues the proposed order;
``(iii) the Secretary requests and obtains the information
under subsection (c) and such information is not submitted in
relation to an order under subsection (b); or
``(iv) the information is of the type contained in raw
datasets.
``(e) Updates to Drug Listing Information.--A sponsor who
makes a change to a drug subject to this section shall submit
updated drug listing information for the drug in accordance
with section 510(j) within 30 calendar days of the date when
the drug is first commercially marketed, except that a
sponsor who was the order requestor with respect to an order
subject to subsection (b)(5)(C) (or a licensee, assignee, or
successor in interest of such requestor) shall submit updated
drug listing information on or before the date when the drug
is first commercially marketed.
``(f) Approvals Under Section 505.--The provisions of this
section shall not be construed to preclude a person from
seeking or maintaining the approval of a drug under sections
505(b)(1), 505(b)(2), and 505(j). A determination under this
section that a drug is not subject to section 503(b)(1), is
generally recognized as safe and effective within the meaning
of section 201(p)(1), and is not a new drug under section
201(p) shall constitute a finding that the drug is safe and
effective that may be relied upon for purposes of an
application under section 505(b)(2), so that the applicant
shall be required to submit for purposes of such application
only information needed to support any modification of the
drug that is not covered by such determination under this
section.
``(g) Public Availability of Administrative Orders.--The
Secretary shall establish, maintain, update (as determined
necessary by the Secretary but no less frequently than
annually), and make publicly available, with respect to
orders issued under this section--
``(1) a repository of each final order and interim final
order in effect, including the complete text of the order;
and
``(2) a listing of all orders proposed and under
development under subsection (b)(2), including--
``(A) a brief description of each such order; and
``(B) the Secretary's expectations, if resources permit,
for issuance of proposed orders over a three-year period.
``(h) Development Advice to Sponsors or Requestors.--The
Secretary shall establish procedures under which sponsors or
requestors may meet with appropriate officials of the Food
and Drug Administration to obtain advice on the studies and
other information necessary to support submissions under this
section and other matters relevant to the regulation of
nonprescription drugs and the development of new
nonprescription drugs under this section.
``(i) Participation of Multiple Sponsors or Requestors.--
The Secretary shall establish procedures to facilitate
efficient participation by multiple sponsors or requestors in
proceedings under this section, including provision for joint
meetings with multiple sponsors or requestors or with
organizations nominated by sponsors or requestors to
represent their interests in a proceeding.
``(j) Electronic Format.--All submissions under this
section shall be in electronic format.
``(k) Effect on Existing Regulations Governing
Nonprescription Drugs.--
``(1) Regulations of general applicability to
nonprescription drugs.--Except as provided in this
subsection, nothing in this section supersedes regulations
establishing general requirements for nonprescription drugs,
including regulations of general applicability contained in
parts 201, 250, and 330 of title 21, Code of Federal
Regulations, or any successor regulations. The Secretary
shall establish or modify such regulations by means of
rulemaking in accordance with section 553 of title 5, United
States Code.
``(2) Regulations establishing requirements for specific
nonprescription drugs.--
``(A) The provisions of section 310.545 of title 21, Code
of Federal Regulations, as in effect on the day before the
date of the enactment of this section, shall be deemed to be
a final order under subsection (b).
``(B) Regulations in effect on the day before the date of
the enactment of this section, establishing requirements for
specific nonprescription drugs marketed pursuant to this
section (including such requirements in parts 201 and 250 of
title 21, Code of Federal Regulations), shall be deemed to be
final orders under subsection (b), only as they apply to
drugs--
``(i) subject to paragraph (1), (2), (3), or (4) of
subsection (a); or
``(ii) otherwise subject to an order under this section.
``(3) Withdrawal of regulations.--The Secretary shall
withdraw regulations establishing final monographs and the
procedures governing the over-the-counter drug review under
part 330 and other relevant parts of title 21, Code of
Federal Regulations (as in effect on the day before the date
of the enactment of this section), or make technical changes
to such regulations to ensure conformity with appropriate
terminology and cross references. Notwithstanding subchapter
II of chapter 5 of title 5, United States Code, any such
withdrawal or technical changes shall be made without public
notice and comment and shall be effective upon publication
through notice in the Federal Register (or upon such date as
specified in such notice).
``(l) Guidance.--The Secretary shall issue guidance that
specifies--
``(1) the procedures and principles for formal meetings
between the Secretary and sponsors or requestors for drugs
subject to this section;
``(2) the format and content of data submissions to the
Secretary under this section;
``(3) the format of electronic submissions to the Secretary
under this section;
``(4) consolidated proceedings and the procedures for such
proceedings where appropriate; and
``(5) for minor changes in drugs, recommendations on how to
comply with the requirements in orders issued under
subsection (c)(3).
``(m) Rule of Construction.--
``(1) In general.--This section shall not affect the
treatment or status of a nonprescription drug--
``(A) that is marketed without an application approved
under section 505 as of the date of the enactment of this
section;
``(B) that is not subject to an order issued under this
section; and
``(C) to which paragraphs (1), (2), (3), (4), or (5) of
subsection (a) do not apply.
``(2) Treatment of products previously found to be subject
to time and extent requirements.--
``(A) Notwithstanding subsection (a), a drug described in
subparagraph (B) may only be lawfully marketed, without an
application approved under section 505, pursuant to an order
issued under this section.
``(B) A drug described in this subparagraph is a drug
which, prior to the date of the enactment of this section,
the Secretary had determined in a proposed or final rule to
be ineligible for review under the OTC drug review (as such
phrase `OTC drug review' was used in section 330.14 of title
21, Code of Federal Regulations, as in effect on the day
before the date of the enactment of this section).
``(3) Preservation of authority.--
``(A) Nothing in paragraph (1) shall be construed to
preclude or limit the applicability of any other provision of
this Act.
``(B) Nothing in subsection (a) shall be construed to
prohibit the Secretary from issuing an order under this
section finding a drug to be not generally recognized as safe
and effective within the meaning of section 201(p)(1), as the
Secretary determines appropriate.
``(n) Investigational New Drugs.--A drug is not subject to
this section if an exemption for investigational use under
section 505(i) is in effect for such drug.
``(o) Inapplicability of Paperwork Reduction Act.--Chapter
35 of title 44, United States Code, shall not apply to
collections of information made under this section.
``(p) Inapplicability of Notice and Comment Rulemaking and
Other Requirements.--The requirements of subsection (b) shall
apply with respect to orders issued under this section
instead of the requirements of subchapter II of chapter 5 of
title 5, United States Code.
``(q) Definitions.--In this section:
``(1) The term `nonprescription drug' refers to a drug not
subject to the requirements of section 503(b)(1).
``(2) The term `sponsor' refers to any person marketing,
manufacturing, or processing a drug that--
``(A) is listed pursuant to section 510(j); and
``(B) is or will be subject to an administrative order of
the Food and Drug Administration.
``(3) The term `requestor' refers to any person or group of
persons marketing, manufacturing, processing, or developing a
drug.''.
[[Page H6232]]
SEC. 102. MISBRANDING.
Section 502 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352) is amended by adding at the end the following:
``(ee) If it is a nonprescription drug that is subject to
section 505G, is not the subject of an application approved
under section 505, and does not comply with the requirements
under section 505G.
``(ff) If it is a drug and it was manufactured, prepared,
propagated, compounded, or processed in a facility for which
fees have not been paid as required by section 744O.''.
SEC. 103. DRUGS EXCLUDED FROM THE OVER-THE-COUNTER DRUG
REVIEW.
(a) In General.--Nothing in this Act (or the amendments
made by this Act) shall apply to any nonprescription drug
which was excluded by the Food and Drug Administration from
the Over-the-Counter Drug Review in accordance with the
statement set out at page 9466 of volume 37 of the Federal
Register, published on May 11, 1972.
(b) Rule of Construction.--Nothing in this section shall be
construed to preclude or limit the applicability of any other
provision of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
SEC. 104. TREATMENT OF SUNSCREEN INNOVATION ACT.
(a) Review of Nonprescription Sunscreen Active
Ingredients.--
(1) Applicability of section 505g for pending
submissions.--
(A) In general.--A sponsor of a nonprescription sunscreen
active ingredient or combination of nonprescription sunscreen
active ingredients that, as of the date of enactment of this
Act, is subject to a proposed sunscreen order under section
586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360fff-3) may elect, by means of giving written notification
to the Secretary of Health and Human Services within 180
calendar days of the enactment of this Act, to transition
into the review of such ingredient or combination of
ingredients pursuant to the process set out in section 505G
of the Federal Food, Drug, and Cosmetic Act, as added by
section 101 of this Act.
(B) Election exercised.--Upon receipt by the Secretary of
Health and Human Services of a timely notification under
subparagraph (A)--
(i) the proposed sunscreen order involved is deemed to be a
request for an order under subsection (b) of section 505G of
the Federal Food, Drug, and Cosmetic Act, as added by section
101 of this Act; and
(ii) such order is deemed to have been accepted for filing
under subsection (b)(6)(A)(i) of such section 505G.
(C) Election not exercised.--A sponsor of a nonprescription
sunscreen active ingredient or combination of nonprescription
sunscreen active ingredients described in subparagraph (A)
that does not elect for such ingredient or combination of
ingredients to be reviewed under section 505G of the Federal
Food, Drug, and Cosmetic Act, as added by section 101 of this
Act, shall continue to have such ingredient or combination of
ingredients reviewed in accordance with section 586C of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3) and
may not subsequently elect to transition into the review of
such ingredient or combination of ingredients pursuant to the
process set out in section 505G of such Act, as added by
section 101 of this Act.
(2) Definitions.--In this subsection, the terms
``sponsor'', ``nonprescription'', ``sunscreen active
ingredient'', and ``proposed sunscreen order'' have the
meanings given to those terms in section 586 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360fff).
(b) Amendments to Sunscreen Provisions.--
(1) Final sunscreen orders.--Paragraph (3) of section
586C(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360fff-3(e)) is amended to read as follows:
``(3) Relationship to orders under section 505g.--A final
sunscreen order shall be deemed to be a final order under
section 505G.''.
(2) Meetings.--Paragraph (7) of section 586C(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(b))
is amended--
(A) by striking ``A sponsor may request'' and inserting the
following:
``(A) In general.--A sponsor may request''; and
(B) by adding at the end the following:
``(B) Confidential meetings.--A sponsor may request one or
more confidential meetings with respect to a proposed
sunscreen order, including a letter deemed to be a proposed
sunscreen order under paragraph (3), to discuss matters
involving confidential commercial information or trade
secrets. The Secretary shall convene a confidential meeting
with such sponsor in a reasonable time period. If a sponsor
requests more than one confidential meeting for the same
proposed sunscreen order, the Secretary may refuse to grant
an additional confidential meeting request if the Secretary
determines that such additional confidential meeting is not
reasonably necessary for the sponsor to advance its proposed
sunscreen order, or if the request for a confidential meeting
fails to include sufficient information upon which to base a
substantive discussion. The Secretary shall publish a post-
meeting summary of each confidential meeting under this
subparagraph that does not disclose confidential commercial
information or trade secrets.''.
(3) Sunset provision.--Subchapter I of chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et
seq.) is amended by adding at the end the following:
``SEC. 586H. SUNSET.
``This subchapter shall cease to be effective at the end of
fiscal year 2022.''.
(4) Treatment of final sunscreen order.--The Federal Food,
Drug, and Cosmetic Act is amended by striking section 586E of
such Act (21 U.S.C. 360fff-5).
(c) Treatment of Non-Sunscreen Time and Extent
Applications.--
(1) In general.--Any application described in section 586F
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360fff-6) that was submitted to the Secretary of Health and
Human Services pursuant to section 330.14 of title 21, Code
of Federal Regulations, as such provisions were in effect
immediately prior to the date of enactment date of this Act,
shall be extinguished as of such date of enactment, subject
to paragraph (2).
(2) Order request.--Nothing in paragraph (1) precludes the
submission of an order request under section 505G(b) of the
Federal Food, Drug, and Cosmetic Act, as added by section 101
of this Act, with respect to a drug that was the subject of
an application extinguished under paragraph (1).
SEC. 105. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC
INDICATION FOR CERTAIN OTC COUGH AND COLD
DRUGS.
(a) In General.--Subject to subsection (c), the Secretary
of Health and Human Services shall, beginning not later than
one year after the date of enactment of this Act, annually
submit to the Committee on Energy and Commerce of the House
of Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a letter describing the
progress of the Food and Drug Administration--
(1) in evaluating the cough and cold monograph described in
subsection (b) with respect to children under age 6; and
(2) as appropriate, revising such cough and cold monograph
to address such children through the order process under
section 505G(b) of the Federal Food, Drug, and Cosmetic Act,
as added by section 101 of this Act.
(b) Cough and Cold Monograph Described.--The cough and cold
monograph described in this subsection consists of the
conditions under which nonprescription drugs containing
antitussive, expectorant, nasal decongestant, or
antihistamine active ingredients (or combinations thereof)
are generally recognized as safe and effective, as specified
in part 341 of title 21, Code of Federal Regulations (as in
effect immediately prior to the date of enactment of this
Act), and included in an order deemed to be established under
section 505G(b) of the Federal Food, Drug, and Cosmetic Act,
as added by section 101 of this Act.
(c) Duration of Authority.--The requirement under
subsection (a) shall terminate as of the date of a letter
submitted by the Secretary of Health and Human Services
pursuant to such subsection in which the Secretary indicates
that the Food and Drug Administration has completed its
evaluation and revised, in a final order, as applicable, the
cough and cold monograph as described in subsection (a)(2).
TITLE II--USER FEES
SEC. 201. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Over-
the-Counter Monograph User Fee Act of 2018''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made in this title will be dedicated to OTC
monograph drug activities, as set forth in the goals
identified for purposes of part 10 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act, in the
letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate and the Chairman of the Committee
on Energy and Commerce of the House of Representatives, as
set forth in the Congressional Record.
SEC. 202. FEES RELATING TO OVER-THE-COUNTER DRUGS.
Subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379f et seq.) is amended by inserting
after part 9 the following:
``PART 10--FEES RELATING TO OVER-THE-COUNTER DRUGS
``SEC. 744N. DEFINITIONS.
``In this part:
``(1) The term `affiliate' means a business entity that has
a relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power to
control, the other business entity; or
``(B) a third party controls, or has power to control, both
of the business entities.
``(2) The term `contract manufacturing organization
facility' means an OTC monograph drug facility where neither
the owner of such manufacturing facility nor any affiliate of
such owner or facility sells the OTC monograph drug produced
at such facility directly to wholesalers, retailers, or
consumers in the United States.
``(3) The term `costs of resources allocated for OTC
monograph drug activities' means the expenses in connection
with OTC monograph drug activities for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to
such officers, employees, and committees and costs related to
contracts with such contractors;
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under section 744O and accounting for
resources allocated for OTC monograph drug activities.
``(4) The term `FDA establishment identifier' is the unique
number automatically generated by
[[Page H6233]]
Food and Drug Administration's Field Accomplishments and
Compliance Tracking System (FACTS) (or any successor system).
``(5) The term `OTC monograph drug' means a nonprescription
drug without an approved new drug application which is
governed by the provisions of section 505G.
``(6) The term `OTC monograph drug activities' means
activities of the Secretary associated with OTC monograph
drugs and inspection of facilities associated with such
products, including the following activities:
``(A) The activities necessary for review and evaluation of
OTC monographs and OTC monograph order requests, including--
``(i) orders proposing or finalizing applicable conditions
of use for OTC monograph drugs;
``(ii) orders affecting status regarding general
recognition of safety and effectiveness of an OTC monograph
ingredient or combination of ingredients under specified
conditions of use;
``(iii) all OTC monograph drug development and review
activities, including intraagency collaboration;
``(iv) regulation and policy development activities related
to OTC monograph drugs;
``(v) development of product standards for products subject
to review and evaluation;
``(vi) meetings referred to in section 505G(i);
``(vii) review of labeling prior to issuance of orders
related to OTC monograph drugs or conditions of use; and
``(viii) regulatory science activities related to OTC
monograph drugs.
``(B) Inspections related to OTC monograph drugs.
``(C) Monitoring of clinical and other research conducted
in connection with OTC monograph drugs.
``(D) Safety activities with respect to OTC monograph
drugs, including--
``(i) collecting, developing, and reviewing safety
information on OTC monograph drugs, including adverse event
reports;
``(ii) developing and using improved adverse event data-
collection systems, including information technology systems;
and
``(iii) developing and using improved analytical tools to
assess potential safety risks, including access to external
databases.
``(E) Other activities necessary for implementation of
section 505G.
``(7) The term `OTC monograph order request' means a
request for an order submitted under section 505G(b)(5).
``(8) The term `Tier 1 OTC monograph order request' means
any OTC monograph order request not determined to be a Tier 2
OTC monograph order request.
``(9)(A) The term `Tier 2 OTC monograph order request'
means, subject to subparagraph (B), an OTC monograph order
request for--
``(i) the reordering of existing information in the drug
facts label of an OTC monograph drug;
``(ii) the addition of information to the other information
section of the drug facts label of an OTC monograph drug, as
limited by section 201.66(c)(7) of title 21, Code of Federal
Regulations (or any successor regulations);
``(iii) modification to the directions for use section of
the drug facts label of an OTC monograph drug, if such
changes conform to changes made pursuant to section
505G(c)(3)(A);
``(iv) the standardization of the concentration or dose of
a specific finalized ingredient within a particular finalized
monograph;
``(v) a change to ingredient nomenclature to align with
nomenclature of a standards-setting organization; or
``(vi) addition of an interchangeable term in accordance
with section 330.1 of title 21, Code of Federal Regulations
(or any successor regulations).
``(B) The Secretary may, based on program implementation
experience or other factors found appropriate by the
Secretary, characterize any OTC monograph order request as a
Tier 2 OTC monograph order request (including
recharacterizing a request from Tier 1 to Tier 2) and publish
such determination in a proposed order issued pursuant to
section 505G.
``(10)(A) The term `OTC monograph drug facility' means a
foreign or domestic business or other entity that--
``(i) is--
``(I) under one management, either direct or indirect; and
``(II) at one geographic location or address engaged in
manufacturing or processing the finished dosage form of an
OTC monograph drug;
``(ii) includes a finished dosage form manufacturer
facility in a contractual relationship with the sponsor of
one or more OTC monograph drugs to manufacture or process
such drugs; and
``(iii) does not include a business or other entity whose
only manufacturing or processing activities are one or more
of the following: production of clinical research supplies,
or testing.
``(B) For purposes of subparagraph (A)(i)(II), separate
buildings or locations within close proximity are considered
to be at one geographic location or address if the activities
conducted in such buildings or locations are--
``(i) closely related to the same business enterprise;
``(ii) under the supervision of the same local management;
and
``(iii) under a single FDA establishment identifier and
capable of being inspected by the Food and Drug
Administration during a single inspection.
``(C) If a business or other entity would meet criteria
specified in subparagraph (A), but for being under multiple
management, the business or other entity is deemed to
constitute multiple facilities, one per management entity,
for purposes of this paragraph.
``(11) The term `OTC monograph drug meeting' means any
meeting regarding the content of a proposed OTC monograph
order request.
``(12) The term `person' includes an affiliate of a person.
``(13) The terms `requestor' and `sponsor' have the
meanings given such terms in section 505G.
``SEC. 744O. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.
``(a) Types of Fees.--Beginning with fiscal year 2019, the
Secretary shall assess and collect fees in accordance with
this section as follows:
``(1) Facility fee.--
``(A) In general.--Each person that owns a facility
identified as an OTC monograph drug facility on December 31
of the fiscal year or at any time during the preceding 12-
month period shall be assessed an annual fee for each such
facility as determined under subsection (c).
``(B) Exceptions.--
``(i) A fee shall not be assessed under subparagraph (A) if
the identified OTC monograph drug facility has ceased all
activities related to OTC monograph drugs prior to the date
specified in subparagraph (D)(ii) and has updated its
registration to reflect such change under the requirements
for drug establishment registration set forth in section 510.
``(ii) The amount of the fee for a contract manufacturing
organization facility shall be equal to \2/3\ the amount of
the fee for an OTC monograph drug facility that is not a
contract manufacturing organization facility.
``(C) Amount.--The amount of fees established under
subparagraph (A) shall be established under subsection (c).
``(D) Due date.--
``(i) For first program year.--For fiscal year 2019, the
facility fees required under subparagraph (A) shall be due 45
calendar days after publication of the Federal Register
notice provided for under subsection (c)(4)(A).
``(ii) Subsequent fiscal years.--For each fiscal year after
fiscal year 2019, the facility fees required under
subparagraph (A) shall be due on the later of--
``(I) the first business day of June of such year; or
``(II) the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of fees under this section for such year.
``(2) OTC monograph order request fee.--
``(A) In general.--Each person that submits an OTC
monograph order request shall be subject to a fee for an OTC
monograph order request. The amount of such fee shall be--
``(i) for a Tier 1 OTC monograph order request, $500,000,
adjusted for inflation for the fiscal year (as determined
under subsection (c)(1)(B)); and
``(ii) for a Tier 2 OTC monograph order request, $100,000
adjusted for inflation for the fiscal year (as determined
under subsection (c)(1)(B)).
``(B) Due date.--The OTC monograph order request fees
required under subparagraph (A) shall be due on the date of
submission of the OTC monograph order request.
``(C) Exception for certain safety changes.--A person who
is named as the requestor in an OTC monograph order shall not
be subject to a fee under subparagraph (A) if the Secretary
finds that the OTC monograph order request seeks to change
the drug facts labeling of an OTC monograph drug in a way
that would add to or strengthen--
``(i) a contraindication, warning, or precaution;
``(ii) a statement about risk associated with misuse or
abuse; or
``(iii) an instruction about dosage and administration that
is intended to increase the safe use of the OTC monograph
drug.
``(D) Refund of fee if order request is recategorized as a
tier 2 otc monograph order request.--If the Secretary
determines that an OTC monograph request initially
characterized as Tier 1 shall be re-characterized as a Tier 2
OTC monograph order request, and the requestor has paid a
Tier 1 fee in accordance with subparagraph (A)(i), the
Secretary shall refund the requestor the difference between
the Tier 1 and Tier 2 fees determined under subparagraphs
(A)(i) and (A)(ii), respectively.
``(E) Refund of fee if order request refused for filing or
withdrawn before filing.--The Secretary shall refund 75
percent of the fee paid under subparagraph (B) for any order
request which is refused for filing or was withdrawn before
being accepted or refused for filing.
``(F) Fees for order requests previously refused for filing
or withdrawn before filing.--An OTC monograph order request
that was submitted but was refused for filing, or was
withdrawn before being accepted or refused for filing, shall
be subject to the full fee under subparagraph (A) upon being
resubmitted or filed over protest.
``(G) Refund of fee if order request withdrawn.--If an
order request is withdrawn after the order request was filed,
the Secretary may refund the fee or a portion of the fee if
no substantial work was performed on the order request after
the application was filed. The Secretary shall have the sole
discretion to refund a fee or a portion of the fee under this
subparagraph. A determination by the Secretary concerning a
refund under this subparagraph shall not be reviewable.
``(3) Refunds.--
``(A) In general.--Other than refunds provided in
subparagraphs (D) through (G) of paragraph (2), the Secretary
shall not refund any fee paid under paragraph (1) except as
provided in subparagraph (B).
``(B) Disputes concerning fees.--To qualify for the return
of a fee claimed to have been paid in error under paragraph
(1) or (2), a person shall submit to the Secretary a written
request justifying such return within 180 calendar days after
such fee was paid.
``(4) Notice.--Within the timeframe specified in subsection
(c), the Secretary shall publish in the Federal Register the
amount of the fees under paragraph (1) for such fiscal year.
[[Page H6234]]
``(b) Fee Revenue Amounts.--
``(1) Fiscal year 2019.--For fiscal year 2019, fees under
subsection (a)(1) shall be established to generate a total
facility fee revenue amount equal to the sum of--
``(A) the annual base revenue for fiscal year 2019 (as
determined under paragraph (3);
``(B) the dollar amount equal to the operating reserve
adjustment for the fiscal year, if applicable (as determined
under subsection (c)(2)); and
``(C) additional direct cost adjustments (as determined
under subsection (c)(3)).
``(2) Subsequent fiscal years.--For each of the fiscal
years 2020 through 2023, fees under subsection (a)(1) shall
be established to generate a total facility fee revenue
amount equal to the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (3));
``(B) the dollar amount equal to the inflation adjustment
for the fiscal year (as determined under subsection (c)(1));
``(C) the dollar amount equal to the operating reserve
adjustment for the fiscal year, if applicable (as determined
under subsection (c)(2));
``(D) additional direct cost adjustments (as determined
under subsection (c)(3)); and
``(E) additional dollar amounts for each fiscal year as
follows:
``(i) $7,000,000 for fiscal year 2020.
``(ii) $6,000,000 for fiscal year 2021.
``(iii) $7,000,000 for fiscal year 2022.
``(iv) $3,000,000 for fiscal year 2023.
``(3) Annual base revenue.--For purposes of paragraphs
(1)(A) and (2)(A), the dollar amount of the annual base
revenue for a fiscal year shall be--
``(A) for fiscal year 2019, $8,000,000; and
``(B) for fiscal years 2020 through 2023, the dollar amount
of the total revenue amount established under this subsection
for the previous fiscal year, not including any adjustments
made under subsection (c)(2) or (c)(3).
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection (b)(2)(B),
the dollar amount of the inflation adjustment to the annual
base revenue for fiscal year 2020 and each subsequent fiscal
year shall be equal to the product of--
``(i) such annual base revenue for the fiscal year under
subsection (b)(2); and
``(ii) the inflation adjustment percentage under
subparagraph (C).
``(B) OTC monograph order request fees.--For purposes of
subsection (a)(2), the dollar amount of the inflation
adjustment to the fee for OTC monograph order requests for
fiscal year 2020 and each subsequent fiscal year shall be
equal to the product of--
``(i) the applicable fee under subsection (a)(2) for the
preceding fiscal year; and
``(ii) the inflation adjustment percentage under
subparagraph (C).
``(C) Inflation adjustment percentage.--The inflation
adjustment percentage under this subparagraph for a fiscal
year is equal to--
``(i) for each of fiscal years 2020 and 2021, the average
annual percent change that occurred in the Consumer Price
Index for urban consumers (Washington-Baltimore, DC-MD-VA-WV;
Not Seasonally Adjusted; All items; Annual Index) for the
first 3 years of the preceding 4 years of available data; and
``(ii) for each of fiscal years 2022 and 2023, the sum of--
``(I) the average annual percent change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 years of
the preceding 4 fiscal years, multiplied by the proportion of
personnel compensation and benefits costs to total costs of
OTC monograph drug activities for the first 3 years of the
preceding 4 fiscal years; and
``(II) the average annual percent change that occurred in
the Consumer Price Index for urban consumers (Washington-
Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the preceding 4 years
of available data multiplied by the proportion of all costs
other than personnel compensation and benefits costs to total
costs of OTC monograph drug activities for the first 3 years
of the preceding 4 fiscal years.
``(2) Operating reserve adjustment.--
``(A) In general.--For fiscal year 2019 and subsequent
fiscal years, for purposes of subsections (b)(1)(B) and
(b)(2)(C), the Secretary may, in addition to adjustments
under paragraph (1), further increase the fee revenue and
fees if such an adjustment is necessary to provide operating
reserves of carryover user fees for OTC monograph drug
activities for not more than the number of weeks specified in
subparagraph (B).
``(B) Number of weeks.--The number of weeks specified in
this subparagraph is--
``(i) 3 weeks for fiscal year 2019;
``(ii) 7 weeks for fiscal year 2020;
``(iii) 10 weeks for fiscal year 2021;
``(iv) 10 weeks for fiscal year 2022; and
``(v) 10 weeks for fiscal year 2023.
``(C) Decrease.--If the Secretary has carryover balances
for such process in excess of 10 weeks of the operating
reserves referred to in subparagraph (A), the Secretary shall
decrease the fee revenue and fees referred to in such
subparagraph to provide for not more than 10 weeks of such
operating reserves.
``(D) Rationale for adjustment.--If an adjustment under
this paragraph is made, the rationale for the amount of the
increase or decrease (as applicable) in fee revenue and fees
shall be contained in the annual Federal Register notice
under paragraph (4) establishing fee revenue and fees for the
fiscal year involved.
``(3) Additional direct cost adjustment.--The Secretary
shall, in addition to adjustments under paragraphs (1) and
(2), further increase the fee revenue and fees for purposes
of subsection (b)(2)(D) by an amount equal to--
``(A) $14,000,000 for fiscal year 2019;
``(B) $7,000,000 for fiscal year 2020;
``(C) $4,000,000 for fiscal year 2021;
``(D) $3,000,000 for fiscal year 2022; and
``(E) $3,000,000 for fiscal year 2023.
``(4) Annual fee setting.--
``(A) Fiscal year 2019.--The Secretary shall, not later
than January 31, 2019--
``(i) establish OTC monograph drug facility fees for fiscal
year 2019 under subsection (a), based on the revenue amount
for such year under subsection (b) and the adjustments
provided under this subsection; and
``(ii) publish fee revenue, facility fees, and OTC
monograph order requests in the Federal Register.
``(B) Subsequent fiscal years.--The Secretary shall, not
later than January 31 of each fiscal year that begins after
September 30, 2019, establish for each such fiscal year,
based on the revenue amounts under subsection (b) and the
adjustments provided under this subsection--
``(i) OTC monograph drug facility fees under subsection
(a)(1);
``(ii) OTC monograph order request fees under subsection
(a)(2); and
``(iii) publish such fee revenue amounts, facility fees,
and OTC monograph order request fees in the Federal Register.
``(d) Identification of Facilities.--Each person that owns
an OTC monograph drug facility shall submit to the Secretary
the information required under this subsection each year.
Such information shall, for each fiscal year--
``(1) be submitted as part of the requirements for drug
establishment registration set forth in section 510; and
``(2) include for each such facility, at a minimum,
identification of the facility's business operation as that
of an OTC monograph drug facility.
``(e) Effect of Failure To Pay Fees.--
``(1) OTC monograph drug facility fee.--
``(A) In general.--Failure to pay the fee under subsection
(a)(1) within 20 calendar days of the due date as specified
in subparagraph (D) of such subsection shall result in the
following:
``(i) The Secretary shall place the facility on a publicly
available arrears list.
``(ii) All OTC monograph drugs manufactured in such a
facility or containing an ingredient manufactured in such a
facility shall be deemed misbranded under section 502(a).
``(B) Application of penalties.--The penalties under this
paragraph shall apply until the fee established by subsection
(a)(1) is paid.
``(2) Order requests.--An OTC monograph order request
submitted by a person subject to fees under subsection (a)
shall be considered incomplete and shall not be accepted for
filing by the Secretary until all fees owed by such person
under this section have been paid.
``(3) Meetings.--A person subject to fees under this
section shall be considered ineligible for OTC monograph drug
meetings until all such fees owed by such person have been
paid.
``(f) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in
appropriations Acts. Such fees are authorized to remain
available until expended. Such sums as may be necessary may
be transferred from the Food and Drug Administration salaries
and expenses appropriation account without fiscal year
limitation to such appropriation account for salaries and
expenses with such fiscal year limitation. The sums
transferred shall be available solely for OTC monograph drug
activities.
``(2) Collections and appropriation acts.--
``(A) In general.--Subject to subparagraph (C), the fees
authorized by this section shall be collected and available
in each fiscal year in an amount not to exceed the amount
specified in appropriation Acts, or otherwise made available
for obligation, for such fiscal year.
``(B) Use of fees and limitation.--The fees authorized by
this section shall be available to defray increases in the
costs of the resources allocated for OTC monograph drug
activities (including increases in such costs for an
additional number of full-time equivalent positions in the
Department of Health and Human Services to be engaged in such
activities), only if the Secretary allocates for such purpose
an amount for such fiscal year (excluding amounts from fees
collected under this section) no less than $12,000,000,
multiplied by the adjustment factor applicable to the fiscal
year involved under subsection (c)(1).
``(C) Compliance.--The Secretary shall be considered to
have met the requirements of subparagraph (B) in any fiscal
year if the costs funded by appropriations and allocated for
OTC monograph drug activities are not more than 15 percent
below the level specified in such subparagraph.
``(D) Provision for early payments in subsequent years.--
Payment of fees authorized under this section for a fiscal
year (after fiscal year 2019), prior to the due date for such
fees, may be accepted by the Secretary in accordance with
authority provided in advance in a prior year appropriations
Act.
``(3) Authorization of appropriations.--For each of the
fiscal years 2019 through 2023, there is authorized to be
appropriated for fees under this section an amount equal to
the total amount of fees assessed for such fiscal year under
this section.
``(g) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 calendar days after it is due, such
fee shall be treated as a claim of the United States
Government subject to subchapter II of chapter 37 of title
31, United States Code.
``(h) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of
[[Page H6235]]
Health and Human Services, for officers, employers, and
advisory committees not engaged in OTC monograph drug
activities, be reduced to offset the number of officers,
employees, and advisory committees so engaged.
``SEC. 744P. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Report.--Beginning with fiscal year 2019,
and not later than 120 calendar days after the end of each
fiscal year thereafter for which fees are collected under
this part, the Secretary shall prepare and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report concerning the
progress of the Food and Drug Administration in achieving the
goals identified in the letters described in section 201(b)
of the Over-the-Counter Monograph Safety, Innovation, and
Reform Act of 2018 during such fiscal year and the future
plans of the Food and Drug Administration for meeting such
goals.
``(b) Fiscal Report.--Not later than 120 calendar days
after the end of fiscal year 2019 and each subsequent fiscal
year for which fees are collected under this part, the
Secretary shall prepare and submit to the Committee on Energy
and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report on the implementation of the authority for
such fees during such fiscal year and the use, by the Food
and Drug Administration, of the fees collected for such
fiscal year.
``(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to
the public on the Internet website of the Food and Drug
Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals described
in subsection (a), and plans for meeting the goals, for OTC
monograph drug activities for the first 5 fiscal years after
fiscal year 2023, and for the reauthorization of this part
for such fiscal years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the House of
Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer advocacy
groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under paragraph
(1) to the congressional committees specified in such
paragraph;
``(B) publish such recommendations in the Federal Register;
``(C) provide for a period of 30 calendar days for the
public to provide written comments on such recommendations;
``(D) hold a meeting at which the public may present its
views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2023, the Secretary shall transmit to the
Congress the revised recommendations under paragraph (2), a
summary of the views and comments received under such
paragraph, and any changes made to the recommendations in
response to such views and comments.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Ohio (Mr. Latta) and the gentleman from Texas (Mr. Gene Green) each
will control 20 minutes.
The Chair recognizes the gentleman from Ohio.
General Leave
Mr. LATTA. 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 material in the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Ohio?
There was no objection.
Mr. LATTA. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 5333, the Over-the-
Counter Monograph Safety, Innovation, and Reform Act.
Over-the-counter medications are widely used to treat common ailments
such as colds, headaches, and seasonal allergies. In fact, more than
240 million Americans use OTC products every year and trust these
affordable remedies to get well and stay well.
Despite the success and high utilization of these medicines, the Food
and Drug Administration's regulatory framework for oversight of OTC
products, also called the monograph system, is outdated and incomplete.
The system was created more than 45 years ago, yet movement on
unfinished items has ground to a halt due to the cumbersome notice and
comment rulemaking process. I will give an example that was pointed out
in committee that the FDA brought out.
The FDA advanced notice proposed rulemaking for this one started on
December 4, 1979. Through a process of 20 different procedures they
went through, they got to November 19, 1997, almost 18 years later, and
what do they do? They reopen the administrative records to consider new
data. It is taking too long. That is what this bill would remedy.
The lack of modernization makes it impossible for manufacturers to
address safety concerns and offers little incentive to develop new
products.
H.R. 5333, which I introduced with the Health Subcommittee chairman,
the gentleman from Texas (Mr. Burgess); the Health Subcommittee vice
chairman, the gentleman from Kentucky (Mr. Guthrie); the Health
Subcommittee ranking member, the gentleman from Texas (Mr. Gene Green),
the gentlewoman from Colorado (Ms. DeGette); and the gentlewoman from
Michigan (Mrs. Dingell) would provide meaningful and long overdue
reform to FDA's monograph system.
The necessary reforms would create a more flexible framework that
accounts for advances in science, permits timely updates to safety
information and label changes, and creates a workable process for
completing unfinished monographs.
By updating the current burdensome process, Congress would also
create a pathway to market for new and innovative products that greatly
benefit our constituents and reduce strain on our healthcare system.
Safe, reliable, and affordable OTC drugs allow consumers to treat
common ailments at home, usually without visiting a healthcare
provider, saving the healthcare system $102 billion annually.
Our bill would improve regulatory certainty for manufacturers and,
over time, we would see additional investment in research and
development, leading to new, innovative OTC medicines that will
continue to save Americans and our healthcare system money.
I thank my colleagues, FDA, and stakeholders for working so closely
with me over the last 2 years to ensure that this modernization effort
appropriately addresses and resolves this complex issue.
I strongly urge my colleagues to support passage of H.R. 5333 to
modernize the broken monograph system, strengthen consumer protection,
spur innovation, and increase consumer choice.
Mr. Speaker, I reserve the balance of my time.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I
may consume.
Mr. Speaker, I rise today in support of H.R. 5333, the Over-the-
Counter Monograph, Safety, Innovation and Reform Act.
I am a proud original cosponsor of this legislation that will
strengthen the Food and Drug Administration's ability to oversee the
over-the-counter drug market and establish a user fee program for this
market for the first time.
H.R. 5333 is legislation that enjoys bipartisan support and would
reform the current monograph system that is relied upon by industry to
legally market over-the-counter drugs in response to concerns raised by
both the FDA and the industry that the current system is outdated and
burdensome.
Under current law, the safety and effectiveness of over-the-counter
drugs is established through conformance with a monograph. Monographs
serve as a type of rule book outlining the conditions of use for a
particular drug ingredient, including the dosage form, patient
population, labeling and warnings, and other requirements. This rule
book is established currently through a three-phase rulemaking process
and is very resource and time intensive.
This process has made it difficult for the FDA to finalize, revise,
or update monographs to reflect innovations, changes in science, or to
respond to safety issues.
We also have heard from the industry that the current process
inadvertently discourages innovation, as it is not nimble enough to
respond to evolving science and technology.
The legislation we are considering today would address these concerns
by transitioning the monograph system from rulemaking to administrative
order, create a procedure for the FDA to respond to the needs for
safety label changes, and establish an innovation pathway.
[[Page H6236]]
These reforms can only be successful if it is also accompanied by
stable and reliable funding that more appropriately represents the
growth and science of the over-the-counter industry.
Today, the over-the-counter monograph program oversees more than
100,000 products with a staff of about 30 people and a budget of just
over $8 million. The user fees provided in this bill would help the FDA
transition the monograph program from rulemaking to administrative
order, provide for additional staff capacity, and enable the FDA to
respond to innovation and safety changes in the current market.
I want to thank my colleague from Ohio, Congressman Bob Latta, for
introducing this legislation and for working with me and other members
of our committee. I would like to thank the original cosponsors of the
bill, Representative Diana DeGette, Representative Debbie Dingell,
Chairman Mike Burgess, and Representative Brett Guthrie for their
dedication and hard work on this important issue.
I ask all my colleagues to join me in supporting the Over-the-Counter
Monograph Safety, Innovation, and Reform Act.
Mr. Speaker, I reserve the balance of my time.
Mr. LATTA. Mr. Speaker, I yield such time as he may consume to the
gentleman from Texas (Mr. Burgess), the chairman of the Health
Subcommittee on Energy and Commerce.
Mr. BURGESS. Mr. Speaker, I rise today to speak in support of this
important, bipartisan bill to modernize the regulation of over-the-
counter medicines.
An over-the-counter product is one that the Food and Drug
Administration has found to be safe and effective for direct consumer
use. To date, consumers have access to over 300,000 of these
nonprescription items. We are all familiar with these products, from
cough and cold medicines to antiperspirants, antacids, and sunscreens.
Our pharmacy aisles and medicine cabinets are filled with over-the-
counter products that American consumers rely on each and every day.
These products do not need premarket approval but are required to be
consistent with monographs established by the Food and Drug
Administration. Making a simple change to existing monographs requires
a time-consuming and resource-intensive rulemaking process that can, in
fact, take years to effectuate even if the change is to enhance the
safety of a product. This creates undue delay in potential benefits
seen by consumers and is an inefficient use of public resources.
{time} 1815
Fortunately, the Food and Drug Administration, patient and consumer
groups, and the regulated industry all agreed that reform is necessary
and have spent the past several years engaged in discussions about
modernization of the over-the-counter regulation. Congress worked with
these groups to turn these discussions into legislation that we are
considering this afternoon.
This bill would make the over-the-counter regulatory framework more
science based and responsive to public health concerns. It would
encourage the development of more innovative products and would provide
resources to the Food and Drug Administration to bolster the agency's
ability to review over-the-counter applications and regulate this
sector in a consistent manner.
Quite simply, it is a meaningful bill for each American.
I want to thank our Energy and Commerce Committee Members,
Representatives Latta from Ohio, Diana DeGette from Colorado, Brett
Guthrie from Kentucky, Debbie Dingell from Michigan, as well as Ranking
Member Green, my colleague from Texas, for their leadership in this
legislation.
I also want to recognize the hard work and the dedication of
committee staff on this legislation, particularly Warren Burke and
Michelle Vanek of the Office of Legislative Counsel; Danielle Steele,
with our majority staff; and Kim Trzeciak, with the committee's
Democratic staff. I urge my colleagues to support the passage of this
bill.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield 3 minutes to the
gentlewoman from Michigan (Mrs. Dingell).
=========================== NOTE ===========================
July 16, 2018, on page H6236, the following appeared: Mr. GREEN
of Texas. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Michigan (Mrs. Dingell).
The online version has been corrected to read: Mr. GENE GREEN of
Texas. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Michigan (Mrs. Dingell).
========================= END NOTE =========================
Mrs. DINGELL. Mr. Speaker, I thank the gentleman from Texas for
yielding to me.
Mr. Speaker, I rise in support of H.R. 5333, the Over-the-Counter
Monograph Safety, Innovation, and Reform Act of 2018, and I want to
thank Chairman Walden and Ranking Member Pallone for bringing this
important bill to the floor.
The monograph system for regulating over-the-counter drugs is broken,
plain and simple. Mr. Speaker, 60 percent of all medicines sold in the
United States are over the counter, yet the FDA only has 18 full-time
employees overseeing the market. It doesn't work for patients; it
doesn't work for companies; and it doesn't work for the FDA.
Companies cannot bring new, innovative products to market and the FDA
cannot act quickly when they are faced with a safety risk. This is not
reflective of how our healthcare system should be run, and it is
putting patients at risk.
Our legislation helps bring the agency into the 21st century by
creating a user fee program at FDA for OTC drugs and by making it
easier to bring a new, innovative product to the market. From past
experience, we know that user fee programs have been very successful at
FDA, and this bill extends that successful model to the OTC space.
Today, the FDA has to go through the cumbersome rulemaking process to
update a monograph, which is problematic for many different reasons.
Not only does it make it harder for innovative products to come to
market, but it also makes it nearly impossible for the FDA to amend
existing monographs if they see safety concerns in certain products.
We need to make sure FDA has the ability to act quickly if they see
unsafe products in the market, and our legislation makes it easier for
the agency to do so. This is why the bill has the support of industry
groups and consumer groups.
Mr. Speaker, I know that there has been much discussion about the
exclusivity provisions of this legislation. It has been debated in
committee, and we compromised with 18 months of exclusivity. I will be
the first to admit it is not perfect, but, on balance, the public
health benefits of this bill outweigh any concerns about exclusivity.
Americans deserve to have the most innovative products on the market
available to them, while ensuring the FDA has the resources they need
to protect public health. I am proud to say that this legislation
accomplishes both these goals.
I, too, want to thank my colleagues, Bob Latta, Diana DeGette, Brett
Guthrie, Gene Green, Dr. Burgess, Chairman Walden, and Ranking Member
Pallone for all their hard work on this legislation. Their staffs
worked tirelessly as well on this, and I want to thank all of them for
their efforts.
Passage of this bill represents another step towards getting our
legislation signed into law this year. I urge my colleagues to support
H.R. 5333.
Mr. LATTA. Mr. Speaker, I yield 2 minutes to the gentleman from
Georgia (Mr. Carter), my friend and colleague.
Mr. CARTER of Georgia. Mr. Speaker, I would like to thank my
colleagues for introducing this critical legislation.
As it stands, the OTC monograph system is slow and outdated, leading
to new changes being stuck in the pipeline for years with no light at
the end of the tunnel. As a pharmacist, I know how important it is to
my patients that they have access to new uses and applications.
Regardless of the application needed under a monograph, today's
legislation puts in place changes that will help those who I have spent
my life assisting: the patient.
This legislation establishes a mechanism for safety label changes,
giving these new efforts an outlet through which to get changes for the
public quickly available and on shelves.
This critical legislation will shorten market exclusivity by 6 months
for certain new over-the-counter products approved without a new drug
application and will also bolster the staffing capability at the FDA
overseeing the OTC drug industry.
Over-the-counter drug innovation has faced challenges for years, and,
with
[[Page H6237]]
this legislation, we finally have an opportunity to open up these
channels that will help everyone.
I voted for this legislation through the subcommittee and through
full committee and am proud to offer my full support to pass this
legislation.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield 3 minutes to the
gentlewoman from Colorado (Ms. DeGette), my colleague and a member of
our committee.
=========================== NOTE ===========================
July 16, 2018, on page H6237, the following appeared: Mr. GREEN
of Texas. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Colorado (Ms. Degette), my colleague and a member of our
committee.
The online version has been corrected to read: Mr. GENE GREEN of
Texas. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Colorado (Ms. Degette), my colleague and a member of our
committee.
========================= END NOTE =========================
Ms. DeGETTE. Mr. Speaker, today we have an opportunity to make long-
overdue reforms to the way that the FDA reviews over-the-counter
medicines. These medicines play a critical role in treating Americans'
ailments and in helping us stay healthy. In fact, almost 7 in 10
parents report giving their kids OTC medicine to help treat sudden
medical symptoms. Similarly, 81 percent of adults use these drugs as a
first response to treat a minor ailment.
Think about it. Despite the widespread use of over-the-counter
medicines, the FDA is currently forced to use a cumbersome and
laborious monograph pathway to approve them. This antiquated, 40-year-
old OTC review system has not kept pace with new medical advances and
the rapid expansion of this market, which now comprises over 300,000
drugs. As a result, the current monograph review system fails to
respond to the OTC safety issues in a timely and effective way, which
can pose serious healthcare risks for children and families.
Between 2004 and 2005, for example, the Centers for Disease Control
and Prevention reported 1,500 cases of children under the age of 2
visiting emergency rooms due to serious side effects or overdoses
associated with over-the-counter cough and cold products.
Since the CDC made this startling finding, the FDA has been trying to
revise the cough and cold monograph system to warn parents about the
risks that these common drugs can pose to children, but the FDA can't
do it because they have been hamstrung due to the burdensome process it
must undergo to revise these monographs.
The Over-the-Counter Monograph Safety, Innovation, and Reform Act
would streamline the FDA's review of over-the-counter drugs and provide
it with new tools to protect children and warn parents about
potentially dangerous OTC drugs.
I want to add my thanks to the bipartisan team that passed this bill,
Representatives Latta, Burgess, Green, Guthrie, and Dingell for all
working together with me on this important legislation, and, in
addition, Ranking Member Pallone, Chairman Walden, the FDA, and the
many stakeholders that have worked closely with us throughout the
process.
Mr. Speaker, the bill is a rare triple win for regulators, consumers,
and industry. I urge my colleagues' support.
Mr. GENE GREEN of Texas. Mr. Speaker, I have no other speakers, and I
yield back the balance of my time.
=========================== NOTE ===========================
July 16, 2018, on page H6237, the following appeared: Mr. GREEN
of Texas. Mr. Speaker, I have no other speakers, and I yield back
the balance of my time.
The online version has been corrected to read: Mr. GENE GREEN of
Texas. Mr. Speaker, I have no other speakers, and I yield back the
balance of my time.
========================= END NOTE =========================
Mr. LATTA. Mr. Speaker, once again, I just want to thank all the
members for all their hard work on this. Especially, I want to thank
the gentleman from Oregon, the chairman of the full committee, for his
work on this piece of legislation. Also, I want to thank the staff.
Mr. Speaker, I urge passage of the bill.
The SPEAKER pro tempore (Mr. Smith of Nebraska). The question is on
the motion offered by the gentleman from Ohio (Mr. Latta) that the
House suspend the rules and pass the bill, H.R. 5333, 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.
____________________