[House Report 115-827]
[From the U.S. Government Publishing Office]
115th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 115-827
======================================================================
OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION, AND REFORM ACT OF 2018
_______
July 16, 2018.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Walden, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
together with
ADDITIONAL VIEWS
[To accompany H.R. 5333]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
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, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 22
Background and Need for Legislation.............................. 23
Committee Action................................................. 23
Committee Votes.................................................. 23
Oversight Findings and Recommendations........................... 25
New Budget Authority, Entitlement Authority, and Tax Expenditures 25
Congressional Budget Office Estimate............................. 25
Federal Mandates Statement....................................... 46
Statement of General Performance Goals and Objectives............ 46
Duplication of Federal Programs.................................. 46
Committee Cost Estimate.......................................... 46
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 47
Disclosure of Directed Rule Makings.............................. 47
Advisory Committee Statement..................................... 47
Applicability to Legislative Branch.............................. 47
Section-by-Section Analysis of the Legislation................... 47
Changes in Existing Law Made by the Bill, as Reported............ 53
Additional Views................................................. 94
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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
``(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.
``(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);
``(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 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.''.
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 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.
``(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
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.''.
Purpose and Summary
The legislation would amend the Federal Food, Drug, and
Cosmetic Act to reform the over-the-counter (OTC) monograph
regulatory framework. To streamline the current regulatory
process, the legislation would create a system for future
changes to OTC monographs to be done through an administrative
order procedure with the opportunity for development meetings
or other consultations, submission of comments on proposed
orders, and dispute resolution procedures. To transition the
OTC monograph framework to an administrative order process, the
legislation includes, by reference, the OTC Drug Review Final
Monographs and Tentative Final Monographs in the statute. The
legislation would also create a mechanism for faster safety
label changes and establish a pathway for innovations under the
monographs. To support these reforms, the legislation would
authorize a new user fee program subject to agreement between
the Food and Drug Administration (FDA) and manufacturers on
performance goals, reporting milestones, and financial
specifications.
Background and Need for Legislation
An OTC drug can be marketed if FDA approves a new drug
application or if the drug conforms to a monograph, which is a
set of standard specifications established by FDA for each
therapeutic category of product. If a product conforms to these
specifications, FDA considers it to be generally recognized as
safe and effective and it can be marketed without a product-
specific application being approved by the agency. FDA began
evaluating twenty-six therapeutic categories of OTC drug
products in 1972 and has yet to finalize monographs for each of
them. Due in large part to the multi-phase public rulemaking
process required even for changes to the monograph, such as
label warnings or new dosage forms, the current process is
inefficient and does not enable product advancements to reach
consumers quickly.
Committee Action
On September 13, 2017, the Subcommittee on Health held a
hearing on a discussion draft entitled ``Over-the-Counter
Monograph Safety, Innovation, and Reform Act of 2018.'' The
Subcommittee received testimony from:
Janet Woodcock, M.D., Director, Center for
Drug Evaluation and Research, Food and Drug
Administration;
Scott Melville, President and CEO, Consumer
Health Products Association;
Kirsten Moore, Project Director, Health Care
Products, The Pew Charitable Trusts;
Michael Werner, Partner, Holland and Knight,
on behalf of the Public Access to SunScreens (PASS)
Coalition;
Bridgette Jones, M.D., Chair, American
Academy of Pediatrics; and
Gil Roth, President, Pharma and Biopharma
Outsourcing Association.
On January 17, 2018, the Subcommittee on Health met in open
markup session and forwarded the discussion draft, without
amendment, to the full Committee by a voice vote. On May 9,
2018, the full Committee on Energy and Commerce met in open
markup session and ordered H.R. 5333, as amended, favorably
reported to the House by a voice vote. H.R. 5333 was similar to
the discussion draft forwarded to the full Committee.
Committee Votes
Clause 3(b) of rule XIII requires the Committee to list the
record votes on the motion to report legislation and amendments
thereto. The following reflects the record votes taken during
the Committee consideration:
Oversight Findings and Recommendations
Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of
rule XIII, the Committee held a hearing and made findings that
are reflected in this report.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to clause 3(c)(2) of rule XIII, the Committee
finds that H.R. 5333 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII, the following is
the cost estimate provided by the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974.
Opioid Legislation
Summary: On May 9 and May 17, 2018, the House Committee on
Energy and Commerce ordered 59 bills to be reported related to
the nation's response to the opioid epidemic. Generally, the
bills would:
Provide grants to facilities and providers
that treat people with substance use disorders,
Direct various agencies within the
Department of Health and Human Services (HHS) to
explore nonopioid approaches to treating pain and to
educate providers about those alternatives,
Modify requirements under Medicaid and
Medicare for prescribing controlled substances,
Expand Medicaid coverage for substance abuse
treatment, and
Direct the Food and Drug Administration
(FDA) to modify its oversight of opioid drugs and other
medications that are used to manage pain.
Because of the large number of related bills ordered
reported by the Committee, CBO is publishing a single
comprehensive document that includes estimates for each piece
of legislation.
CBO estimates that enacting 20 of the bills would affect
direct spending, and 2 of the bills would affect revenues;
therefore, pay-as-you-go procedures apply for those bills.
CBO estimates that enacting H.R. 4998, the Health Insurance
for Former Foster Youth Act, would increase net direct spending
by more than $2.5 billion and on-budget deficits by more than
$5 billion in at least one of the four consecutive 10-year
periods beginning in 2029. None of the remaining 58 bills
included in this estimate would increase net direct spending by
more than $2.5 billion or on-budget deficits by more than $5
billion in any of the four consecutive 10-year periods
beginning in 2029.
One of the bills reviewed for this document, H.R. 5795,
would impose both intergovernmental and private-sector mandates
as defined in the Unfunded Mandates Reform Act (UMRA). CBO
estimates that the costs of those mandates on public and
private entities would fall below the thresholds in UMRA ($80
million and $160 million, respectively, in 2018, adjusted
annually for inflation). Five bills, H.R. 5228, H.R. 5333, H.R.
5554, H.R. 5687, and H.R. 5811, would impose private-sector
mandates as defined in UMRA. CBO estimates that the costs of
the mandates in three of the bills (H.R. 5333, H.R. 5554, and
H.R. 5811) would not exceed the UMRA threshold for private
entities. Because CBO is uncertain how federal agencies would
implement new authority granted in the other two bills, H.R.
5228 and H.R. 5687, CBO cannot determine whether the costs of
those mandates would exceed the UMRA threshold.
Estimated cost to the Federal Government: The estimates in
this document do not include the effects of interactions among
the bills. If all 59 bills were combined and enacted as one
piece of legislation, the budgetary effects would be different
from the sum of the estimates in this document, although CBO
expects that any such differences would be small. The costs of
this legislation fall within budget functions 550 (health), 570
(Medicare), 750 (administration of justice), and 800 (general
government).
Basis of estimate: For this estimate, CBO assumes that all
of the legislation will be enacted late in 2018 and that
authorized and estimated amounts will be appropriated each
year. Outlays for discretionary programs are estimated based on
historical spending patterns for similar programs.
Uncertainty
CBO aims to produce estimates that generally reflect the
middle of a range of the most likely budgetary outcomes that
would result if the legislation was enacted. Because data on
the utilization of mental health and substance abuse treatment
under Medicaid and Medicare is scarce, CBO cannot precisely
predict how patients or providers would respond to some policy
changes or what budgetary effects would result. In addition,
several of the bills would give the Department of Health and
Human Services (HHS) considerable latitude in designing and
implementing policies. Budgetary effects could differ from
those provided in CBO's analyses depending on those decisions.
Direct Spending and Revenues
Table 1 lists the 22 bills of the 59 ordered to be reported
that would affect direct spending or revenues.
TABLE 1.--ESTIMATED CHANGES IN MANDATORY SPENDING AND REVENUES
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
------------------------------------------------------------------------------------------------------------------
2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2019-2023 2019-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
INCREASES OR DECREASES (-) IN DIRECT SPENDING
Legislation Primarily Affecting
Medicaid:
H.R. 1925, At-Risk Youth Medicaid 0 * 5 5 5 10 10 10 10 10 10 25 75
Protection Act of 2017..........
H.R. 4998, Health Insurance for 0 0 0 0 0 * 10 21 33 46 61 * 171
Former Foster Youth Act.........
H.R. 5477, Rural Development of 0 13 35 58 68 83 27 9 3 3 3 256 301
Opioid Capacity Services Act....
H.R. 5583, a bill to amend title 0 * * * * * * * * * * * *
XI of the Social Security Act to
require States to annually
report on certain adult health
quality measures, and for other
purposes........................
H.R. 5797, IMD CARE Act.......... 0 38 158 251 265 279 0 0 0 0 0 991 991
H.R. 5799, Medicaid DRUG 0 * * 1 1 1 1 1 1 1 1 2 5
Improvement Acta................
H.R. 5801, Medicaid Providers Are 0 * * * * * * * * * * * *
Required To Note Experiences in
Record Systems to Help In-Need
Patients (PARTNERSHIP) Act a....
H.R. 5808, Medicaid 0 * -1 -1 -1 -1 -2 -2 -2 -2 -2 -4 -13
Pharmaceutical Home Act of 2018a
H.R. 5810, Medicaid Health HOME 0 94 58 62 56 52 48 43 38 32 25 323 509
Act.............................
Legislation Primarily Affecting
Medicare:
H.R. 3528, Every Prescription 0 0 0 -24 -35 -33 -30 -33 -32 -31 -32 -92 -250
Conveyed Securely Act...........
H.R. 4841, Standardizing 0 0 0 * * * * * * * * * *
Electronic Prior Authorization
for Safe Prescribing Act of 2018
H.R. 5603, Access to Telehealth 0 2 * * * 1 1 1 2 2 2 3 11
Services for Opioid Use
Disorders Act...................
H.R. 5605, Advancing High Quality 0 0 0 15 26 24 23 23 10 1 * 65 122
Treatment for Opioid Use
Disorders in Medicare Act.......
H.R. 5675, a bill to amend title 0 0 0 -6 -7 -7 -7 -8 -9 -9 -11 -20 -64
XVIII of the Social Security Act
to require prescription drug
plan sponsors under the Medicare
program to establish drug
management programs for at-risk
beneficiaries...................
H.R. 5684, Protecting Seniors 0 0 0 * * * * * * * * * *
From Opioid Abuse Act...........
H.R. 5796, Responsible Education 0 10 25 50 10 5 0 0 0 0 0 100 100
Achieves Care and Healthy
Outcomes for Users' Treatment
Act of 2018.....................
H.R. 5798, Opioid Screening and 0 0 * 1 1 1 1 1 1 1 1 2 5
Chronic Pain Management
Alternatives for Seniors Act....
H.R. 5804, Post-Surgical 0 0 25 30 25 20 10 5 0 0 0 100 115
Injections as an Opioid
Alternative Acta................
H.R. 5809, Postoperative Opioid 0 0 0 0 10 15 20 25 30 35 45 25 180
Prevention Act of 2018..........
Legislation Primarily Affecting the
Food and Drug Administration:
H.R. 5333, Over-the-Counter 0 0 * * * * * * * * * * *
Monograph Safety, Innovation,
and Reform Act of 2018a.........
INCREASES OR DECREASES (-) IN REVENUESb
H.R. 5752, Stop Illicit Drug 0 * * * * * * * * * * * *
Importation Act of 2018.............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding * = between -$500,000 and $500,000. Budget authority is equivalent to outlays.
aThis bill also would affect spending subject to appropriation.
bOne additional bill, H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, would have a negligible effect on revenues.
Legislation Primarily Affecting Medicaid. The following
nine bills would affect direct spending for the Medicaid
program.
H.R. 1925, the At-Risk Youth Medicaid Protection Act of
2017, would require states to suspend, rather than terminate,
Medicaid eligibility for juvenile enrollees (generally under 21
years of age) who become inmates of public correctional
institutions. States also would have to redetermine those
enrollees' Medicaid eligibility before their release and
restore their coverage upon release if they qualify for the
program. States would be required to process Medicaid
applications submitted by or on behalf of juveniles in public
correctional institutions who were not enrolled in Medicaid
before becoming inmates and ensure that Medicaid coverage is
provided when they are released if they are found to be
eligible. On the basis of an analysis of juvenile incarceration
trends and of the per enrollee spending for Medicaid foster
care children, who have a similar health profile to
incarcerated juveniles, CBO estimates that implementing the
bill would cost $75 million over the 2019-2028 period.
H.R. 4998, the Health Insurance for Former Foster Youth
Act, would require states to provide Medicaid coverage to
adults up to age 25 who had aged out of foster care in any
state. Under current law, such coverage is mandatory only if
the former foster care youth has aged out in the state in which
the individual applies for coverage. The policy also would
apply to former foster children who had been in foster care
upon turning 14 years of age but subsequently left foster care
to enter into a legal guardianship with a kinship caregiver.
The provisions would take effect respect for foster youth who
turn 18 on or after January 1, 2023. On the basis of spending
for Medicaid foster care children and data from the Census
Bureau regarding annual migration rates between states, CBO
estimates that implementing the bill would cost $171 million
over the 2019-2028 period.
H.R. 5477, the Rural Development of Opioid Capacity
Services Act, would direct the Secretary of HHS to conduct a
five-year demonstration to increase the number and ability of
providers participating in Medicaid to provide treatment for
substance use disorders. On the basis of an analysis of federal
and state spending for treatment of substance use disorders and
the prevalence of such disorders, CBO estimates that enacting
the bill would increase direct spending by $301 million over
the 2019-2028 period.
H.R. 5583, a bill to amend title XI of the Social Security
Act to require States to annually report on certain adult
health quality measures, and for other purposes, would require
states to include behavioral health indicators in their annual
reports on the quality of care under Medicaid. Although the
bill would add a requirement for states, CBO estimates that its
enactment would not have a significant budgetary effect because
most states have systems in place for reporting such measures
to the federal government.
H.R. 5797, the IMD CARE Act, would expand Medicaid coverage
for people with opioid use disorder who are in institutions for
mental disease (IMDs) for up to 30 days per year. Under a
current-law policy known as the IMD exclusion, the federal
government generally does not make matching payments to state
Medicaid programs for most services provided by IMDs to adults
between the ages of 21 and 64. Recent administrative changes
have made federal financing for IMDs available in limited
circumstances, but the statutory prohibition remains in place.
CBO analyzed several data sets, primarily those collected by
the Substance Abuse and Mental Health Services Administration
(SAMHSA), to estimate current federal spending under Medicaid
for IMD services and to estimate spending under H.R. 5797.
Using that analysis, CBO estimates that enacting H.R. 5797
would increase direct spending by $991 million over the 2019-
2028 period.
H.R. 5799, the Medicaid DRUG Improvement Act, would require
state Medicaid programs to implement additional reviews of
opioid prescriptions, monitor concurrent prescribing of opioids
and certain other drugs, and monitor use of antipsychotic drugs
by children. CBO estimates that the bill would increase direct
spending by $5 million over the 2019-2028 period to cover the
administrative costs of complying with those requirements. On
the basis of stakeholder feedback, CBO expects that the bill
would not have a significant effect on Medicaid spending for
prescription drugs because many of the bill's requirements
would duplicate current efforts to curb opioid and
antipsychotic drug use. (If enacted, H.R. 5799 also would
affect spending subject to appropriation; CBO has not completed
an estimate of that amount.)
H.R. 5801, the Medicaid Providers Are Required To Note
Experiences in Record Systems to Help In-Need Patients
(PARTNERSHIP) Act, would require providers who are permitted to
prescribe controlled substances and who participate in Medicaid
to query prescription drug monitoring programs (PDMPs) before
prescribing controlled substances to Medicaid patients. PDMPs
are statewide electronic databases that collect data on
controlled substances dispensed in the state. The bill also
would require PDMPs to comply with certain data and system
criteria, and it would provide additional federal matching
funds to certain states to help cover administrative costs. On
the basis of a literature review and stakeholder feedback, CBO
estimates that the net budgetary effect of enacting H.R. 5801
would be insignificant. Costs for states to come into
compliance with the systems and administrative requirements
would be roughly offset by savings from small reductions in the
number of controlled substances paid for by Medicaid under the
proposal. (If enacted, H.R. 5801 also would affect spending
subject to appropriation; CBO has not completed an estimate of
that amount.)
H.R. 5808, the Medicaid Pharmaceutical Home Act of 2018,
would require state Medicaid programs to operate pharmacy
programs that would identify people at high risk of abusing
controlled substances and require those patients to use a
limited number of providers and pharmacies. Although nearly all
state Medicaid programs currently meet such a requirement, a
small number of high-risk Medicaid beneficiaries are not now
monitored. Based on an analysis of information about similar
state and federal programs, CBO estimates that net Medicaid
spending under the bill would decrease by $13 million over the
2019-2028 period. That amount represents a small increase in
administrative costs and a small reduction in the number of
controlled substances paid for by Medicaid under the proposal.
(If enacted, H.R. 5808 also would affect spending subject to
appropriation; CBO has not completed an estimate of that
amount.)
H.R. 5810, the Medicaid Health HOME Act, would allow states
to receive six months of enhanced federal Medicaid funding for
programs that coordinate care for people with substance use
disorders. Based on enrollment and spending data from states
that currently participate in Medicaid's Health Homes program,
CBO estimates that the expansion would cost approximately $469
million over the 2019-2028 period. The bill also would require
states to cover all FDA-approved drugs used in medication-
assisted treatment for five years, although states could seek a
waiver from that requirement. (Medication-assisted treatment
combines behavioral therapy and pharmaceutical treatment for
substance use disorders.) Under current law, states already
cover most FDA-approved drugs used in such programs in some
capacity, although a few exclude methadone dispensed by opioid
treatment programs. CBO estimates that a small share of those
states would begin to cover methadone if this bill was enacted
at a federal cost of about $39 million over the 2019-2028
period. In sum, CBO estimates that enacting H.R. 5810 would
increase direct spending by $509 million over the 2019-2028
period.
Legislation Primarily Affecting Medicare. The following ten
bills would affect direct spending for the Medicare program.
H.R. 3528, the Every Prescription Conveyed Securely Act,
would require prescriptions for controlled substances covered
under Medicare Part D to be transmitted electronically,
starting on January 1, 2021. Based on CBO's analysis of
prescription drug spending, spending for controlled substances
is a small share of total drug spending. CBO also assumes a
small share of those prescriptions would not be filled because
they are not converted to an electronic format. Therefore, CBO
expects that enacting H.R. 3528 would reduce the number of
prescriptions filled and estimates that Medicare spending would
be reduced by $250 million over the 2019-2028 period.
H.R. 4841, the Standardizing Electronic Prior Authorization
for Safe Prescribing Act of 2018, would require health care
professionals to submit prior authorization requests
electronically, starting on January 1, 2021, for drugs covered
under Medicare Part D. Taking into account that many
prescribers already use electronic methods to submit such
requests, CBO estimates that enacting H.R. 4841 would not
significantly affect direct spending for Part D.
H.R. 5603, the Access to Telehealth Services for Opioid Use
Disorders Act, would permit the Secretary of HHS to lift
current geographic and other restrictions on coverage of
telehealth services under Medicare for treatment of substance
use disorders or co-occurring mental health disorders. Under
the bill, the Secretary of HHS would be directed to encourage
other payers to coordinate payments for opioid use disorder
treatments and to evaluate the extent to which the
demonstration reduces hospitalizations, increases the use of
medication-assisted treatments, and improves the health
outcomes of individuals with opioid use disorders during and
after the demonstration. Based on current use of Medicare
telehealth services for treatment of substance use disorders,
CBO estimates that expanding that coverage would increase
direct spending by $11 million over the 2019-2028 period.
H.R. 5605, the Advancing High Quality Treatment for Opioid
Use Disorders in Medicare Act, would establish a five-year
demonstration program to increase access to treatment for
opioid use disorder. The demonstration would provide incentive
payments and funding for care management services based on
criteria such as patient engagement, use of evidence-based
treatments, and treatment length and intensity. Under the bill,
the Secretary of HHS would be directed to encourage other
payers to coordinate payments for opioid use disorder
treatments and to evaluate the extent to which the
demonstration reduces hospitalizations, increases the use of
medication-assisted treatments, and improves the health
outcomes of individuals with opioid use disorders during and
after the demonstration. Based on historical utilization of
opioid use disorder treatments and projected spending on
incentive payments and care management fees, CBO estimates that
increased use of treatment services and the demonstration's
incentive payments would increase direct spending by $122
million over the 2019-2028 period.
H.R. 5675, a bill to amend title XVIII of the Social
Security Act to require prescription drug plan sponsors under
the Medicare program to establish drug management programs for
at-risk beneficiaries, would require Part D prescription drug
plans to provide drug management programs for Medicare
beneficiaries who are at risk for prescription drug abuse.
(Under current law, Part D plans are permitted but not required
to establish such programs as of 2019.) Based on an analysis of
the number of plans currently providing those programs, CBO
estimates that enacting H.R. 5675 would lower federal spending
by $64 million over the 2019-2028 period by reducing the number
of prescriptions filled and Medicare's payments for controlled
substances.
H.R. 5684, the Protecting Seniors From Opioid Abuse Act,
would expand medication therapy management programs under
Medicare Part D to include beneficiaries who are at risk for
prescription drug abuse. Because relatively few beneficiaries
would be affected by this bill, CBO estimates that its
enactment would not significantly affect direct spending for
Part D.
H.R. 5796, the Responsible Education Achieves Care and
Healthy Outcomes for Users' Treatment Act of 2018, would allow
the Secretary of HHS to award grants to certain organizations
that provide technical assistance and education to high-volume
prescribers of opioids. The bill would appropriate $100 million
for fiscal year 2019. Based on historical spending patterns for
similar activities, CBO estimates that implementing H.R. 5796
would cost $100 million over the 2019-2028 period.
H.R. 5798, the Opioid Screening and Chronic Pain Management
Alternatives for Seniors Act, would add an assessment of
current opioid prescriptions and screening for opioid use
disorder to the Welcome to Medicare Initial Preventive Physical
Examination. Based on historical use of the examinations and
pain management alternatives, CBO expects that enacting the
bill would increase use of pain management services and
estimates that direct spending would increase by $5 million
over the 2019-2028 period.
H.R. 5804, the Post-Surgical Injections as an Opioid
Alternative Act, would freeze the Medicare payment rate for
certain analgesic injections provided in ambulatory surgical
centers (ASCs). (For injections identified by specific billing
codes, Medicare would pay the 2016 rate, which is higher than
the current rate, during the 2020-2024 period.) Based on
current utilization in the ASC setting, CBO estimates that
enacting the legislation would increase direct spending by
about $115 million over the 2019-2028 period. (If enacted, H.R.
5804 also would affect spending subject to appropriation; see
Table 3.)
H.R. 5809, the Postoperative Opioid Prevention Act of 2018,
would create an additional payment under Medicare for nonopioid
analgesics. Under current law, certain new drugs and devices
may receive an additional payment--separate from the bundled
payment for a surgical procedure--in outpatient hospital
departments and ambulatory surgical centers. The bill would
allow nonopioid analgesics to qualify for a five-year period of
additional payments. Based on its assessment of current
spending for analgesics and on the probability of new nonopioid
analgesics coming to market, CBO estimates that H.R. 5809 would
increase direct spending by about $180 million over the 2019-
2028 period.
Legislation Primarily Affecting the Food and Drug
Administration. One bill related to the FDA would affect direct
spending.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would change the way that
the FDA regulates the marketing of over-the-counter (OTC)
medicines, and it would authorize that agency to grant 18
months of exclusive market protection for certain qualifying
OTC drugs, thus delaying the entry of other versions of the
same qualifying OTC product. Medicaid currently provides some
coverage for OTC medicines, but only if a medicine is the least
costly alternative in its drug class. On the basis of
stakeholder feedback, CBO expects that delaying the
availability of additional OTC versions of a drug would not
significantly affect the average net price paid by Medicaid. As
a result, CBO estimates that enacting H.R. 5333 would have a
negligible effect on the federal budget. (If enacted, H.R. 5333
also would affect spending subject to appropriation; see Table
3.)
Legislation with Revenue Effects. Two bills would affect
revenues. However, CBO estimates that one bill, H.R. 5228, the
Stop Counterfeit Drugs by Regulating and Enhancing Enforcement
Now Act, would have only a negligible effect.
H.R. 5752, the Stop Illicit Drug Importation Act of 2018,
would amend the Federal, Food, Drug, and Cosmetic Act (FDCA) to
strengthen the FDA's seizure powers and enhance its authority
to detain, refuse, seize, or destroy illegal products offered
for import. The legislation would subject more people to
debarment under the FDCA and thus increase the potential for
violations, and subsequently, the assessment of civil
penalties, which are recorded in the budget as revenues. CBO
estimates that those collections would result in an
insignificant increase in revenues. Because H.R. 5752 would
prohibit the importation of drugs that are in the process of
being scheduled, it also could reduce amounts collected in
customs duties. CBO anticipates that the result would be a
negligible decrease in revenues. With those results taken
together, CBO estimates, enacting H.R. 5752 would generate an
insignificant net increase in revenues over the 2019-2028
period.
Spending Subject to Appropriation
For this document, CBO has grouped bills with spending that
would be subject to appropriation into four general categories:
Bills that would have no budgetary effect,
Bills with provisions that would authorize
specified amounts to be appropriated (see Table 2),
Bills with provisions for which CBO has
estimated an authorization of appropriations (see Table
3), and
Bills with provisions that would affect
spending subject to appropriation for which CBO has not
yet completed an estimate.
No Budgetary Effect. CBO estimates that 6 of the 59 bills
would have no effect on direct spending, revenues, or spending
subject to appropriation.
H.R. 3192, the CHIP Mental Health Parity Act, would require
all Children's Health Insurance Program (CHIP) plans to cover
mental health and substance abuse treatment. In addition,
states would not be allowed to impose financial or utilization
limits on mental health treatment that are lower than limits
placed on physical health treatment. Based on information from
the Centers for Medicare and Medicaid Services, CBO estimates
that enacting the bill would have no budgetary effect because
all CHIP enrollees are already in plans that meet those
requirements.
H.R. 3331, a bill to amend title XI of the Social Security
Act to promote testing of incentive payments for behavioral
health providers for adoption and use of certified electronic
health record technology, would give the Center for Medicare
and Medicaid Innovation (CMMI) explicit authorization to test a
program offering incentive payments to behavioral health
providers that adopt and use certified electronic health record
technology. Because it is already clear to CMMI that it has
that authority, CBO estimates that enacting the legislation
would not affect federal spending.
H.R. 5202, the Ensuring Patient Access to Substance Use
Disorder Treatments Act of 2018, would clarify permission for
pharmacists to deliver controlled substances to providers under
certain circumstances. Because this provision would codify
current practice, CBO estimates that H.R. 5202 would not affect
direct spending or revenues during the 2019-2028 period.
H.R. 5685, the Medicare Opioid Safety Education Act of
2018, would require the Secretary of HHS to include information
on opioid use, pain management, and nonopioid pain management
treatments in future editions of Medicare & You, the program's
handbook for beneficiaries, starting on January 1, 2019.
Because H.R. 5685 would add information to an existing
administrative document, CBO estimates that enacting the bill
would have no budgetary effect.
H.R. 5686, the Medicare Clear Health Options in Care for
Enrollees Act of 2018, would require prescription drug plans
that provide coverage under Medicare Part D to furnish
information to beneficiaries about the risks of opioid use and
the availability of alternative treatments for pain. CBO
estimates that enacting the bill would not affect direct
spending because the required activities would not impose
significant administrative costs.
H.R. 5716, the Commit to Opioid Medical Prescriber
Accountability and Safety for Seniors Act, would require the
Secretary of HHS on an annual basis to identify high
prescribers of opioids and furnish them with information about
proper prescribing methods. Because HHS already has the
capacity to meet those requirements, CBO estimates that
enacting that provision would not impose additional
administrative costs on the agency.
Specified Authorizations. Table 2 lists the ten bills that
would authorize specified amounts to be appropriated over the
2019-2023 period. Spending from those authorized amounts would
be subject to appropriation.
TABLE 2.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH SPECIFIED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
----------------------------------------------------
2018 2019 2020 2021 2022 2023 2019-2023
----------------------------------------------------------------------------------------------------------------
INCREASES IN SPENDING SUBJECT TO APPROPRIATION
H.R. 4684, Ensuring Access to Quality Sober Living Act:
Authorization Level.................................... 0 3 0 0 0 0 3
Estimated Outlays...................................... 0 1 2 * * * 3
H.R. 5102, Substance Use Disorder Workforce Loan Repayment
Act of 2018:
Authorization Level.................................... 0 25 25 25 25 25 125
Estimated Outlays...................................... 0 9 19 23 25 25 100
H.R. 5176, Preventing Overdoses While in Emergency Rooms
Act of 2018:
Authorization Level.................................... 0 50 0 0 0 0 50
Estimated Outlays...................................... 0 16 26 6 2 1 50
H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency
Department Act:
Authorization Level.................................... 0 10 10 10 0 0 30
Estimated Outlays...................................... 0 3 8 10 7 2 30
H.R. 5261, Treatment, Education, and Community Help to
Combat Addiction Act of 2018:
Authorization Level.................................... 0 4 4 4 4 4 20
Estimated Outlays...................................... 0 1 3 4 4 4 16
H.R. 5327, Comprehensive Opioid Recovery Centers Act of
2018:
Authorization Level.................................... 0 10 10 10 10 10 50
Estimated Outlays...................................... 0 3 8 10 10 10 41
H.R. 5329, Poison Center Network Enhancement Act of 2018:
Authorization Level.................................... 0 30 30 30 30 30 151
Estimated Outlays...................................... 0 12 25 29 29 29 125
H.R. 5353, Eliminating Opioid-Related Infectious Diseases
Act of 2018:
Authorization Level.................................... 0 40 40 40 40 40 200
Estimated Outlays...................................... 0 15 34 38 39 40 166
H.R. 5580, Surveillance and Testing of Opioids to Prevent
Fentanyl Deaths Act of 2018:
Authorization Level.................................... 30 30 30 30 30 0 120
Estimated Outlays...................................... 0 11 25 29 29 19 113
H.R. 5587, Peer Support Communities of Recovery Act:
Authorization Level.................................... 0 15 15 15 15 15 75
Estimated Outlays...................................... 0 5 13 14 15 15 62
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between zero and $500,000.
H.R. 4684, the Ensuring Access to Quality Sober Living Act,
would direct the Secretary of HHS to develop and disseminate
best practices for organizations that operate housing designed
for people recovering from substance use disorders. The bill
would authorize a total of $3 million over the 2019-2021 period
for that purpose. Based on historical spending patterns for
similar activities, CBO estimates that implementing H.R. 4684
would cost $3 million over the 2019-2023 period.
H.R. 5102, the Substance Use Disorder Workforce Loan
Repayment Act of 2018, would establish a loan repayment program
for mental health professionals who practice in areas with few
mental health providers or with high rates of death from
overdose and would authorize $25 million per year over the
2019-2028 period for that purpose. Based on historical spending
patterns for similar activities, CBO estimates that
implementing H.R. 5102 would cost $100 million over the 2019-
2023 period; the remaining amounts would be spent in years
after 2023.
H.R. 5176, the Preventing Overdoses While in Emergency
Rooms Act of 2018, would require the Secretary of HHS to
develop protocols and a grant program for health care providers
to address the needs of people who survive a drug overdose, and
it would authorize $50 million in 2019 for that purpose. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5176 would cost $50 million
over the 2019-2023 period.
H.R. 5197, the Alternatives to Opioids (ALTO) in the
Emergency Department Act, would direct the Secretary of HHS to
carry out a demonstration program for hospitals and emergency
departments to develop alternative protocols for pain
management that limit the use of opioids and would authorize
$10 million annually in grants for fiscal years 2019 through
2021. Based on historical spending patterns for similar
programs, CBO estimates that implementing H.R. 5197 would cost
$30 million over the 2019-2023 period.
H.R. 5261, the Treatment, Education, and Community Help to
Combat Addiction Act of 2018, would direct the Secretary of HHS
to designate regional centers of excellence to improve the
training of health professionals who treat substance use
disorders. The bill would authorize $4 million annually for
grants to those programs over the 2019-2023 period. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5261 would cost $16 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R. 5327, the Comprehensive Opioid Recovery Centers Act of
2018, would direct the Secretary of HHS to award grants to at
least 10 providers that offer treatment services for people
with opioid use disorder, and it would authorize $10 million
per year over the 2019-2023 period for that purpose. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5327 would cost $41 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R. 5329, the Poison Center Network Enhancement Act of
2018, would reauthorize the poison control center toll-free
number, national media campaign, and grant program under the
Public Health Service Act. Among other actions, H.R. 5329 would
increase the share of poison control center funding that could
be provided by federal grants. The bill would authorize a total
of about $30 million per year over the 2019-2023 period. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5329 would cost $125 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R. 5353, the Eliminating Opioid Related Infectious
Diseases Act of 2018, would amend the Public Health Service Act
by broadening the focus of surveillance and education programs
from preventing and treating hepatitis C virus to preventing
and treating infections associated with injection drug use. It
would authorize $40 million per year over the 2019-2023 period
for that purpose. Based on historical spending patterns for
similar activities, CBO estimates that implementing H.R. 5353
would cost $166 million over the 2019-2023 period; the
remaining amounts would be spent in years after 2023.
H.R. 5580, the Surveillance and Testing of Opioids to
Prevent Fentanyl Deaths Act of 2018, would establish a grant
program for public health laboratories that conduct testing for
fentanyl and other synthetic opioids. It also would direct the
Centers for Disease Control and Prevention to expand its drug
surveillance program, with a particular focus on collecting
data on fentanyl. The bill would authorize a total of $30
million per year over the 2018-2022 period for those
activities. Based on historical spending patterns for similar
activities, CBO estimates that implementing H.R. 5580 would
cost $113 million over the 2019-2023 period; the remaining
amounts would be spent in years after 2023.
H.R. 5587, Peer Support Communities of Recovery Act, would
direct the Secretary of HHS to award grants to nonprofit
organizations that support community-based, peer-delivered
support, including technical support for the establishment of
recovery community organizations, independent, nonprofit groups
led by people in recovery and their families. The bill would
authorize $15 million per year for the 2019-2023 period. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5587 would cost $62 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
Estimated Authorizations. Table 3 shows CBO's estimates of
the appropriations that would be necessary to implement 19 of
the bills. Spending would be subject to appropriation of those
amounts.
H.R. 449, the Synthetic Drug Awareness Act of 2018, would
require the Surgeon General to report to the Congress on the
health effects of synthetic psychoactive drugs on children
between the ages of 12 and 18. Based on spending patterns for
similar activities, CBO estimates that implementing H.R. 449
would cost approximately $1 million over the 2019-2023 period.
H.R. 4005, the Medicaid Reentry Act, would direct the
Secretary of HHS to convene a group of stakeholders to develop
and report to the Congress on best practices for addressing
issues related to health care faced by those returning from
incarceration to their communities. The bill also would require
the Secretary to issue a letter to state Medicaid directors
about relevant demonstration projects. Based on an analysis of
anticipated workload, CBO estimates that implementing H.R. 4005
would cost less than $500,000 over the 2018-2023 period.
H.R. 4275, the Empowering Pharmacists in the Fight Against
Opioid Abuse Act, would require the Secretary of HHS to develop
and disseminate materials for training pharmacists, health care
practitioners, and the public about the circumstances under
which a pharmacist may decline to fill a prescription. Based on
historical spending patterns for similar activities, CBO
estimates that costs to the federal government for the
development and distribution of those materials would not be
significant.
TABLE 3.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH ESTIMATED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
----------------------------------------------------------
2018 2019 2020 2021 2022 2023 2019-2023
----------------------------------------------------------------------------------------------------------------
INCREASES IN SPENDING SUBJECT TO APPROPRIATION
H.R. 449, Synthetic Drug Awareness Act of 2018:
Estimated Authorization Level.................... 0 * * * 0 0 1
Estimated Outlays................................ 0 * * * 0 0 1
H.R. 4005, Medicaid Reentry Act:
Estimated Authorization Level.................... * * 0 0 0 0 *
Estimated Outlays................................ * * 0 0 0 0 *
H.R. 4275, Empowering Pharmacists in the Fight
Against Opioid Abuse Act:
Estimated Authorization Level.................... 0 * * * * * *
Estimated Outlays................................ 0 * * * * * *
H.R. 5009, Jessie's Law:
Estimated Authorization Level.................... 0 * * * * * *
Estimated Outlays................................ 0 * * * * * *
H.R. 5041, Safe Disposal of Unused Medication Act:
Estimated Authorization Level.................... 0 * * * * * *
Estimated Outlays................................ 0 * * * * * *
H.R. 5272, Reinforcing Evidence-Based Standards Under
Law in Treating Substance Abuse Act of 2018:
Estimated Authorization Level.................... 0 1 1 1 1 1 4
Estimated Outlays................................ 0 1 1 1 1 1 4
H.R. 5333, Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018:a
Food and Drug Administration:
Collections from fees:
Estimated Authorization Level............ 0 -22 -22 -26 -35 -42 -147
Estimated Outlays........................ 0 -22 -22 -26 -35 -42 -147
Spending of fees:
Estimated Authorization Level............ 0 22 22 26 35 42 147
Estimated Outlays........................ 0 6 17 30 44 41 137
Net effect on FDA:
Estimated Authorization Level............ 0 0 0 0 0 0 0
Estimated Outlays........................ 0 -17 -6 4 9 * -10
Government Accountability Office:
Estimated Authorization Level................ 0 0 0 0 0 * *
Estimated Outlays............................ 0 0 0 0 0 * *
Total, H.R. 5333:
Estimated Authorization Level................ 0 0 0 0 0 0 *
Estimated Outlays............................ 0 -17 -6 4 9 * -10
H.R. 5473, Better Pain Management Through Better Data
Act of 2018:
Estimated Authorization Level.................... 0 * * * * 0 1
Estimated Outlays................................ 0 * * * * * 1
H.R. 5483, Special Registration for Telemedicine
Clarification Act of 2018:
Estimated Authorization Level.................... 0 * * * * * *
Estimated Outlays................................ 0 * * * * * *
H.R. 5554, Animal Drug and Animal Generic Drug User
Fee Amendments of 2018:
Collections from fees:
Animal drug fees............................. 0 -30 -31 -32 -33 -34 -159
Generic animal drug fees..................... 0 -18 -19 -19 -20 -21 -97
Total, Estimated Authorization Level..... 0 -49 -50 -51 -53 -55 -257
Total, Estimated Outlays................. 0 -49 -50 -51 -53 -55 -257
Spending of fees:
Animal drug fees............................. 0 30 31 32 33 34 159
Generic animal drug fees..................... 0 18 19 19 20 21 97
Total, Estimated Authorization Level..... 0 49 50 51 53 55 257
Total, Estimated Outlays................. 0 39 47 51 52 54 243
Net changes in fees:
Estimated Authorization Level................ 0 0 0 0 0 0 0
Estimated Outlays............................ 0 -10 -3 * * * -14
Other effects:
Estimated Authorization Level................ 0 3 1 1 1 1 6
Estimated Outlays............................ 0 2 1 1 1 1 6
Total, H.R. 5554:
Estimated Authorization Level................ 0 3 1 1 1 1 6
Estimated Outlays............................ 0 -8 -2 1 * * -8
H.R. 5582, Abuse Deterrent Access Act of 2018:
Estimated Authorization Level.................... 0 0 * 0 0 0 *
Estimated Outlays................................ 0 0 * 0 0 0 *
H.R. 5590, Opioid Addiction Action Plan Act:
Estimated Authorization Level.................... * * * * * * 2
Estimated Outlays................................ * * * * * * 2
H.R. 5687, Securing Opioids and Unused Narcotics with
Deliberate Disposal and Packaging Act of 2018:
Estimated Authorization Level.................... 0 * * * * * *
Estimated Outlays................................ 0 * * * * * *
H.R. 5715, Strengthening Partnerships to Prevent
Opioid Abuse Act:
Estimated Authorization Level.................... 0 2 2 2 2 2 9
Estimated Outlays................................ 0 2 2 2 2 2 9
H.R. 5789, a bill to require the Secretary of Health
and Human Services to issue guidance to improve care
for infants with neonatal abstinence syndrome and
their mothers, and to require the Comptroller
General of the United States to conduct a study on
gaps in Medicaid coverage for pregnant and
postpartum women with substance use disorder:
Estimated Authorization Level.................... 0 2 0 0 0 0 2
Estimated Outlays................................ 0 2 0 0 0 0 2
H.R. 5795, Overdose Prevention and Patient Safety
Act:
Estimated Authorization Level.................... 0 1 0 0 0 0 1
Estimated Outlays................................ 0 1 0 0 0 0 1
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act:
Estimated Authorization Level.................... 0 1 0 0 0 0 1
Estimated Outlays................................ 0 * * 0 0 0 1
H.R. 5804, Post-Surgical Injections as an Opioid
Alternative Act:a
Estimated Authorization Level.................... 0 0 0 0 1 1 1
Estimated Outlays................................ 0 0 0 0 1 1 1
H.R. 5811, a bill to amend the Federal Food, Drug,
and Cosmetic Act with respect to postapproval study
requirements for certain controlled substances, and
for other purposes:
Estimated Authorization Level.................... 0 * * * * * *
Estimated Outlays................................ 0 * * * * * *
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000.
aThis bill also would affect mandatory spending (see Table 1).
H.R. 5009, Jessie's Law, would require HHS, in
collaboration with outside experts, to develop best practices
for displaying information about opioid use disorder in a
patient's medical record. HHS also would be required to develop
and disseminate written materials annually to health care
providers about what disclosures could be made while still
complying with federal laws that govern health care privacy.
Based on spending patterns for similar activities, CBO
estimates that implementing H.R. 5009 would have an
insignificant effect on spending over the 2019-2023 period.
H.R. 5041, the Safe Disposal of Unused Medication Act,
would require hospice programs to have written policies and
procedures for the disposal of controlled substances after a
patient's death. Certain licensed employees of hospice programs
would be permitted to assist in the disposal of controlled
substances that were lawfully dispensed. Using information from
the Department of Justice (DOJ), CBO estimates that
implementing the bill would cost less than $500,000 over the
2019-2023 period.
H.R. 5272, the Reinforcing Evidence-Based Standards Under
Law in Treating Substance Abuse Act of 2018, would require the
newly established National Mental Health and Substance Use
Policy Laboratory to issue guidance to applicants for SAMHSA
grants that support evidence-based practices. Using information
from HHS about the historical cost of similar activities, CBO
estimates that enacting this bill would cost approximately $4
million over the 2019-2023 period.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would change the FDA's
oversight of the commercial marketing of OTC medicines and
authorize the collection and spending of fees through 2023 to
cover the costs of expediting the FDA's administrative
procedures for certain regulatory activities relating to OTC
products. Under H.R. 5333, CBO estimates, the FDA would assess
about $147 million in fees over the 2019-2023 period that could
be collected and made available for obligation only to the
extent and in the amounts provided in advance in appropriation
acts. Because the FDA could spend those fees, CBO estimates
that the estimated budget authority for collections and
spending would offset each other exactly in each year, although
CBO expects that spending initially would lag behind
collections. Assuming appropriation action consistent with the
bill, CBO estimates that implementing H.R. 5333 would reduce
net discretionary outlays by $10 million over the 2019-2023
period, primarily because of that lag. The bill also would
require the Government Accountability Office to study exclusive
market protections for certain qualifying OTC drugs authorized
by the bill--a provision that CBO estimates would cost less
than $500,000. (If enacted, H.R. 5333 also would affect
mandatory spending; see Table 1.)
H.R. 5473, the Better Pain Management Through Better Data
Act of 2018, would require that the FDA conduct a public
meeting and issue guidance to industry addressing data
collection and labeling for medical products that reduce pain
while enabling the reduction, replacement, or avoidance of oral
opioids. Using information from the agency, CBO estimates that
implementing H.R. 5473 would cost about $1 million over the
2019-2023 period.
H.R. 5483, the Special Registration for Telemedicine
Clarification Act of 2018, would direct DOJ, within one year of
the bill's enactment, to issue regulations concerning the 21
practice of telemedicine (for remote diagnosis and treatment of
patients). Using information from DOJ, CBO estimates that
implementing the bill would cost less than $500,000 over the
2019-2023 period.
H.R. 5554, the Animal Drug and Animal Generic Drug User Fee
Amendments of 2018, would authorize the FDA to collect and
spend fees to cover the cost of expedited approval for the
development and marketing of certain drugs for use in animals.
The legislation would extend through fiscal year 2023, and make
several changes to, the FDA's existing approval processes and
fee programs for brand-name and generic veterinary drugs, which
expire at the end of fiscal year 2018. CBO estimates that
implementing H.R. 5554 would reduce net discretionary outlays
by $8 million over the 2019-2023 period, primarily because the
spending of fees lags somewhat behind their collection.
Fees authorized under the bill would supplement funds
appropriated to cover the FDA's cost of reviewing certain
applications and investigational submissions for brand-name and
generic drugs for use in animals. Those fees could be collected
and made available for obligation only to the extent and in the
amounts provided in advance in appropriation acts. Under H.R.
5554, CBO estimates, the FDA would assess about $257 million in
fees over the 2019-2023 period. Because the FDA could spend
those funds, CBO estimates that budget authority for
collections and spending would offset each other exactly in
each year. CBO estimates that the delay between collecting and
spending fees under the reauthorized programs would reduce net
discretionary outlays by $14 million over the 2019-2023 period,
assuming appropriation actions consistent with the bill.
Enacting H.R. 5554 would increase the FDA's workload
because the legislation would expand eligibility for
conditional approval for certain drugs. The agency's
administrative costs also would increase because of regulatory
activities required by a provision concerning petitions for
additives intended for use in animal food. H.R. 5554 also would
require the FDA to publish guidance or produce regulations on a
range of topics, transmit a report to the Congress, and hold
public meetings. CBO expects that the costs associated with
those activities would not be covered by fees, and it estimates
that implementing such provisions would cost $6 million over
the 2019-2023 period.
H.R. 5582, the Abuse Deterrent Access Act of 2018, would
require the Secretary of HHS to report to the Congress on
existing barriers to access to ``abuse-deterrent opioid
formulations'' by Medicare Part C and D beneficiaries. Such
formulations make the drugs more difficult to dissolve for
injection, for example, and thus can impede their abuse.
Assuming the availability of appropriated funds and based on
historical spending patterns for similar activities, CBO
estimates that implementing the legislation would cost less
than $500,000 over the 2019-2023 period.
H.R. 5590, the Opioid Addiction Action Plan Act, would
require the Secretary of HHS to develop an action plan by
January 1, 2019, for increasing access to medication-assisted
treatment among Medicare and Medicaid enrollees. The bill also
would require HHS to convene a stakeholder meeting and issue a
request for information within three months of enactment, and
to submit a report to the Congress by June 1, 2019. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5590 would cost approximately
$2 million over the 2019-2023 period.
H.R. 5687, the Securing Opioids and Unused Narcotics with
Deliberate Disposal and Packaging Act of 2018, would permit the
FDA to require certain packaging and disposal technologies,
controls, or measures to mitigate the risk of abuse and misuse
of drugs. Based on information from the FDA, CBO estimates that
implementing H.R. 5687 would not significantly affect spending
over the 2019-2023 period. This bill would also require that
the GAO study the effectiveness and use of packaging
technologies for controlled substances--a provision that CBO
estimates would cost less than $500,000.
H.R. 5715, the Strengthening Partnerships to Prevent Opioid
Abuse Act, would require the Secretary of HHS to establish a
secure Internet portal to allow HHS, Medicare Advantage plans,
and Medicare Part D plans to exchange information about fraud,
waste, and abuse among providers and suppliers no later than
two years after enactment. H.R. 5715 also would require
organizations with Medicare Advantage contracts to submit
information on investigations related to providers suspected of
prescribing large volumes of opioids through a process
established by the Secretary no later than January 2021. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5715 would cost approximately
$9 million over the 2019-2023 period.
H.R. 5789, a bill to require the Secretary of Health and
Human Services to issue guidance to improve care for infants
with neonatal abstinence syndrome and their mothers, and to
require the Comptroller General of the United States to conduct
a study on gaps in Medicaid coverage for pregnant and
postpartum women with substance use disorder, would direct the
Secretary of HHS to issue guidance to states on best practices
under Medicaid and CHIP for treating infants with neonatal
abstinence syndrome. H.R. 5789 also would direct the Government
Accountability Office to study Medicaid coverage for pregnant
and postpartum women with substance use disorders. Based on
information from HHS and historical spending patterns for
similar activities, CBO estimates that enacting H.R. 5789 would
cost approximately $2 million over the 2019-2023 period.
H.R. 5795, the Overdose Prevention and Patient Safety Act,
would amend the Public Health Service Act so that requirements
pertaining to the confidentiality and disclosure of medical
records relating to substance use disorders align with the
provisions of the Health Insurance Portability and
Accountability Act of 1996. The bill would require the Office
of the Secretary of HHS to issue regulations prohibiting
discrimination based on data disclosed from such medical
records, to issue regulations requiring covered entities to
provide written notice of privacy practices, and to develop
model training programs and materials for health care providers
and patients and their families. Based on spending patterns for
similar activities, CBO estimates that implementing H.R. 5795
would cost approximately $1 million over the 2019-2023 period.
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act, would direct
the Medicaid and CHIP Payment and Access Commission to study
institutions for mental diseases in a representative sample of
states. Based on information from the commission about the cost
of similar work, CBO estimates that implementing H.R. 5800
would cost about $1 million over the 2019-2023 period.
H.R. 5804, the Post-Surgical Injections as an Opioid
Alternative ACt, would freeze the Medicare payment rate for
certain analgesic injections provided in ambulatory surgical
centers. The bill also would mandate two studies of Medicare
coding and payments arising from enactment of this legislation.
Based on the cost of similar activities, CBO estimates that
those reports would cost $1 million over the 2019-2023 period.
(If enacted, H.R. 5804 also would affect mandatory spending;
see Table 1.)
H.R. 5811, a bill to amend the Federal Food, Drug, and
Cosmetic Act with respect to postapproval study requirements
for certain controlled substances, and for other purposes,
would allow the FDA to require that pharmaceutical
manufacturers study certain drugs after they are approved to
assess any potential reduction in those drugs' effectiveness
for the conditions of use prescribed, recommended, or suggested
in labeling. CBO anticipates that implementing H.R. 5811 would
not significantly affect the FDA's costs over the 2019-2023
period.
Other Authorizations. The following nine bills would
increase authorization levels, but CBO has not completed
estimates of amounts. All authorizations would be subject to
future appropriation action.
H.R. 4284, Indexing Narcotics, Fentanyl, and
Opioids Act of 2017
H.R. 5002, Advancing Cutting Edge Research
Act
H.R. 5228, Stop Counterfeit Drugs by
Regulating and Enhancing Enforcement Now Act (see Table
1 for an estimate of the revenue effects of H.R. 5228)
H.R. 5752, Stop Illicit Drug Importation Act
of 2018 (see Table 1 for an estimate of the revenue
effects of H.R. 5752)
H.R. 5799, Medicaid DRUG Improvement Act
(see Table 1 for an estimate of the direct spending
effects of H.R. 5799)
H.R. 5801, Medicaid Providers and
Pharmacists Are Required to Note Experiences in Record
Systems to Help In-Need Patients (PARTNERSHIP) Act (see
Table 1 for an estimate of the direct spending effects
of H.R. 5801)
H.R. 5806, 21st Century Tools for Pain and
Addiction Treatments Act
H.R. 5808, Medicaid Pharmaceutical Home Act
of 2018 (see Table 1 for an estimate of the direct
spending effects of H.R. 5808)
H.R. 5812, Creating Opportunities that
Necessitate New and Enhanced Connections That Improve
Opioid Navigation Strategies Act (CONNECTIONS) Act
Pay-As-You-Go considerations: The Statutory Pay-As-You-Go
Act of 2010 establishes budget-reporting and enforcement
procedures for legislation affecting direct spending or
revenues. Twenty-two of the bills discussed in this document
contain direct spending or revenues and are subject to pay-as-
you-go procedures. Details about the amount of direct spending
and revenues in those bills can be found in Table 1.
Increase in long-term direct spending and deficits: CBO
estimates that enacting H.R. 4998, the Health Insurance for
Former Foster Youth Act, would increase net direct spending by
more than $2.5 billion and on-budget deficits by more than $5
billion in at least one of the four consecutive 10-year periods
beginning in 2029.
CBO estimates that none of the remaining 58 bills included
in this estimate would increase net direct spending by more
than $2.5 billion or on-budget deficits by more than $5 billion
in any of the four consecutive 10-year periods beginning in
2029.
Mandates: One of the 59 bills included in this document,
H.R. 5795, would impose both intergovernmental and private-
sector mandates as defined in UMRA. CBO estimates that the
costs of that bill's mandates on public and private entities
would fall below UMRA's thresholds ($80 million and $160
million, respectively, for public- and private-sector entities
in 2018, adjusted annually for inflation).
In addition, five bills would impose private-sector
mandates as defined in UMRA. CBO estimates that the costs of
the mandates in three of those bills (H.R. 5333, H.R. 5554, and
H.R. 5811) would fall below the UMRA threshold. Because CBO
does not know how federal agencies would implement new
authority granted in the other two of those five bills, H.R.
5228 and 5687, CBO cannot determine whether the costs of their
mandates would exceed the threshold.
For large entitlement grant programs, including Medicaid
and CHIP, UMRA defines an increase in the stringency of
conditions on states or localities as an intergovernmental
mandate if the affected governments lack authority to offset
those costs while continuing to provide required services.
Because states possess significant flexibility to alter their
responsibilities within Medicaid and CHIP, the requirements
imposed by various bills in the markup on state administration
of those programs would not constitute mandates as defined in
UMRA.
Mandates Affecting Public and Private Entities
H.R. 5795, the Overdose Prevention and Patient Safety Act,
would impose intergovernmental and private-sector mandates by
requiring entities that provide treatment for substance use
disorders to notify patients of their privacy rights and also
to notify patients in the event that the confidentiality of
their records is breached. In certain circumstances, H.R. 5795
also would prohibit public and private entities from denying
entry to treatment on the basis of information in patient
health records. Those requirements would either supplant or
narrowly expand responsibilities under existing law, and
compliance with them would not impose significant additional
costs. CBO estimates that the costs of the mandates would fall
below the annual thresholds established in UMRA.
Mandates Affecting Private Entities
Five bills included in this document would impose private-
sector mandates:
H.R. 5228, the Stop Counterfeit Drugs by Regulating and
Enhancing Enforcement Now Act, would require drug distributors
to cease distributing any drug that the Secretary of HHS
determines might present an imminent or substantial hazard to
public health. CBO cannot determine what drugs could be subject
to such an order nor can it determine how private entities
would respond. Consequently, CBO cannot determine whether the
aggregate cost of the mandate would exceed the annual threshold
for private-sector mandates.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would require developers
and manufacturers of OTC drugs to pay certain fees to the FDA.
CBO estimates that about $30 million would be collected each
year, on average, for a total of $147 million over the 2019-
2023 period. Those amounts would not exceed the annual
threshold for private-sector mandates in any year during that
period.
H.R. 5554, the Animal Drug and Animal Generic Drug User Fee
Amendments of 2018, would require developers and manufacturers
of brand-name and generic veterinary drugs to pay application,
product, establishment, and sponsor fees to the FDA. CBO
estimates that about $51 million would be collected annually,
on average, for a total of $257 million over the 2019-2023
period. Those amounts would not exceed the annual threshold for
private-sector mandates in any year during that period.
H.R. 5687, the Securing Opioids and Unused Narcotics with
Deliberate Disposal and Packaging Act of 2018, would permit the
Secretary of HHS to require drug developers and manufacturers
to implement new packaging and disposal technology for certain
drugs. Based on information from the agency, CBO expects that
the Secretary would use the new regulatory authority provided
in the bill; however, it is uncertain how or when those
requirements would be implemented. Consequently, CBO cannot
determine whether the aggregate cost of the mandate would
exceed the annual threshold for private entities.
H.R. 5811, a bill to amend the Federal Food, Drug, and
Cosmetic Act with respect to postapproval study requirements
for certain controlled substances, and for other purposes,
would expand an existing mandate that requires drug developers
to conduct postapproval studies or clinical trials for certain
drugs. Under current law, in certain instances, the FDA can
require studies or clinical trials after a drug has been
approved. H.R. 5811 would permit the FDA to use that authority
if the reduction in a drug's effectiveness meant that its
benefits no longer outweighed its costs. CBO estimates that the
incremental cost of the mandate would fall below the annual
threshold established in UMRA because of the small number of
drugs affected and the narrow expansion of the authority that
exists under current law.
None of the remaining 53 bills included in this document
would impose an intergovernmental or private-sector mandate.
Previous CBO Estimate
On June 6, 2018, CBO issued an estimate for seven opioid-
related bills ordered reported by the House Committee on Ways
and Means on May 16, 2018. Two of those bills contain
provisions that are identical or similar to the legislation
ordered reported by the Committee on Energy and Commerce, and
for those provisions, CBO's estimates are the same.
In particular, five bills listed in this estimate contain
provisions that are identical or similar to those in several
sections of H.R. 5773, the Preventing Addiction for Susceptible
Seniors Act of 2018:
H.R. 5675, which would require prescription
drug plans to implement drug management programs, is
identical to section 2 of H.R. 5773.
H.R. 4841, regarding electronic prior
authorization for prescriptions under Medicare's Part
D, is similar to section 3 of H.R. 5773.
H.R. 5715, which would mandate the creation
of a new Internet portal to allow various stakeholders
to exchange information, is identical to section 4 of
H.R. 5773.
H.R. 5684, which would expand medication
therapy management, is the same as section 5 of H.R.
5773.
H.R. 5716, regarding prescriber
notification, is identical to section 6 of H.R. 5773.
In addition, in this estimate, a provision related to
Medicare beneficiary education in H.R. 5686, the Medicare Clear
Health Options in Care for Enrollees Act of 2018, is the same
as a provision in section 2 of H.R. 5775, the Providing
Reliable Options for Patients and Educational Resources Act of
2018, in CBO's estimate for the Committee on Ways and Means.
Estimate prepared by: Federal Costs: Rebecca Yip (Centers
for Disease Control and Prevention), Mark Grabowicz (Drug
Enforcement Agency), Julia Christensen, Ellen Werble (Food and
Drug Administration), Emily King, Andrea Noda, Lisa Ramirez-
Branum, Robert Stewart (Medicaid and Children's Health
Insurance Program), Philippa Haven, Lara Robillard, Colin Yee,
Rebecca Yip (Medicare), Philippa Haven (National Institutes of
Health), Alice Burns, Andrea Noda (Office of the Secretary of
the Department of Health and Human Services), Philippa Haven,
Lori Housman, Emily King (Substance Abuse and Mental Health
Services Administration, Health Resources and Services
Administration); Federal Revenues: Jacob Fabian, Peter Huether,
and Cecilia Pastrone; Fact Checking: Zachary Byrum and Kate
Kelly; Mandates: Andrew Laughlin.
Estimate reviewed by: Tom Bradley, Chief, Health Systems
and Medicare Cost Estimates Unit; Chad M. Chirico, Chief, Low-
Income Health Programs and Prescription Drugs Cost Estimates
Unit; Sarah Masi, Special Assistant for Health; Susan Willie,
Chief, Mandates Unit; Leo Lex, Deputy Assistant Director for
Budget Analysis; Theresa A. Gullo, Assistant Director for
Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to change
the FDA's oversight of the commercial marketing of OTC
medicines and authorize the collection and spending of fees
through 2023 to cover the costs of expediting the FDA's
administrative procedures for certain regulatory activities
relating to OTC products.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 5333 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 5333 contains no earmarks, limited
tax benefits, or limited tariff benefits.
Disclosure of Directed Rule Makings
Pursuant to section 3(i) of H. Res. 5, the Committee finds
that H.R. 5333 contains no directed rule makings.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
The section provides that the Act may be cited as the
``Over-the-Counter Monograph Safety, Innovation, and Reform Act
of 2018.''
TITLE I--OTC DRUG REVIEW
Section 101. Regulation of certain nonprescription drugs marketed
without an approved new drug application
Section 101 clarifies how nonprescription drugs marketed
without a new drug application (NDA) as of the date of
enactment shall be treated. Drugs that are in conformity with a
final monograph will be deemed to be generally recognized as
safe and effective (GRASE), and not a new drug and not subject
to NDA requirements. Drugs that are in conformity with a
tentative final monograph will be deemed to be GRASE and not a
new drug and not subject to NDA requirements, unless such drug
falls under an administrative order regarding dosage form
changes, is in a dosage form that has been used to a material
time and extent, complies with a future final administrative
order from FDA, or otherwise meets one of the preceding
requirements and follows a minor change of procedure. Drugs
that are classified as Category III and in conformity with a
tentative final monograph or Category I and in conformity with
the conditions proposed in an advanced notice of proposed rule-
making may be legally marketed without a NDA. Drugs classified
in Category II for safety and effectiveness under a tentative
final monograph or that is subject to a determination not to be
safe or effective in a proposed rule shall be deemed to be a
new drug, misbranded, and subjected to the NDA requirements 180
days after enactment unless the Secretary determines it is in
the interest of public health to extend such period.
Sunscreen drugs will be GRASE if they conform with a stayed
final monograph, except that testing conditions governing
labeling will be those contained in a separate, existing
requirement.
Section 101 also transitions the OTC monograph regulatory
process from a rule-making process to an administrative order
process. Administrative orders may be initiated by the
Secretary or by requestors. Such administrative orders will
specify conditions under which specific drugs, classes of
drugs, or combinations of drugs will be subject to a NDA and
GRASE. Administrative orders initiated by the Secretary must be
published on the web site of the FDA and include the reasons
for such order. Sponsors should be notified no later than two
business days before issuance of the proposed orders, and a
public comment period of not less than 45 calendar days shall
be provided. After such comment period, the Secretary will
provide a detailed statement of reasons supporting the issuance
of a final administrative order. The order will not take effect
until the time for requesting judicial review has expired. If
the Secretary is initiating a proposed administrative order
determining that a drug is not GRASE, the Secretary shall
provide the general categories of data supporting such
determination, the format for submissions by interested
persons, and a comment period of 180 days (with a good cause
exception for a shorter comment period). Final or tentative
final monographs for Category I drugs are deemed final
administrative orders.
The section also specifies a hearing procedure to address
concerns with the final administrative order. If a sponsor
objects to an administrative order, they must first pursue
dispute resolution within FDA's Center for Drug Evaluation and
Research (CDER) within 45 days. If there is still a dispute
after that process, the sponsor may pursue a FDA hearing, which
must be requested within 30 days after the CDER dispute
process. CDER may deny a hearing if the hearing request and
administrative record do not establish a genuine and
substantial question of material fact based on data using
relevant and reliable scientific principles and methodologies.
FDA may consolidate hearing requests. The presiding officer for
the hearing will be designated by the Secretary, may not be an
employee of CDER, and may not have been involved in the
development of the administrative order. Parties to the hearing
will have a right to present testimony, including experts, and
to cross-examine witnesses presented by other parties. Judicial
appeals will go to a U.S. District Court and must be filed
within 60 days.
In instances of an imminent hazard to public health, the
Secretary may issue an interim final administrative order,
together with a detailed statement of the reasons for the
order, which would take effect on a specified date. An interim
final order will include at least a 45-day comment period and
would substitute for a proposed order. The interim final order
process will apply to safety labeling changes if the Secretary
determines that such changes are reasonably expected to
mitigate a significant or unreasonable risk of a serious
adverse event associated with the use of a drug. FDA will issue
a final administrative order and a sponsor may pursue dispute
resolution and a hearing within 12 months. Judicial appeal may
follow a final order.
Requestors may initiate an administrative order process to
establish or change conditions for a drug to be found GRASE by
filing a request in a FDA-defined format. FDA will make a
determination if the request is sufficiently complete and
formatted to permit a substantive review. Such administrative
order should be reviewed under the ordinary administrative
order process described above. A requestor may file under
protest with certain limitations. Changes to an order, other
than a change necessary to ensure safety, that provide for a
drug to contain a new active ingredient or a change in the
conditions of use of a drug supported by new human data
essential to the approval of the change, including clinical
trials of safety or effectiveness, actual use studies, or
pharmacokinetics or bioavailability studies will be provided
with an exclusivity period of 18 months from drug listing.
The Comptroller General of the United States is required to
conduct a study not later than four years after enactment to
consider the effectiveness and overall impact of exclusivity
under this section. The study shall include the number of drugs
granted and exclusivity and the indication for which the drug
was determined to be GRASE; whether the exclusivity was for a
drug with a new active ingredient of changes in the conditions
of use; whether and to what extent the exclusivity impacted the
requestor's decision to develop the drug; an analysis of the
implementation of the exclusivity provision, including the
resources used by FDA, the impact on innovation and research
and development, the impact on competition, the impact on
consumer access, the impact on nonprescription drug prices, and
whether the requestor-initiated order process has been
sufficient to encourage the development of nonprescription
drugs that would likely not be otherwise developed or developed
in as timely a manner; and whether the requestor-initiated
order process has been sufficient to encourage innovation in
the nonprescription drug market.
Requests filed to establish a drug not currently in a
monograph is GRASE must include information sufficient for a
threshold determination that the drug has been marketed and
safely used by consumers in the U.S. under comparable
conditions of use; information to demonstrate the drug was
marketed and safely used in a foreign country under conditions
of use for a reasonable period of time and under a regulatory
body of a country listed in section 802(b)(1)(A) or a country
designated by FDA under 802(b)(1)(B); or if FDA determines such
information is not needed to provide a threshold demonstration
that the drug can be safely marketed as an OTC drug.
Administrative orders initiated by the Secretary,
requestor, or posing an imminent hazard to public health may
include packaging requirements. Such requirements may include
unit dose packaging, requirements for products intended for use
by children, requirements to reduce harm from unsupervised
ingestion, or other appropriate requirements.
Minor changes in dosage forms that otherwise are consistent
with the requirements of a monograph may take place without
prior notice at a requestor's discretion so long as that
requestor maintains information on file to demonstrate the
change will not affect safety or effectiveness and will not
materially affect absorption or other exposure to the active
ingredient, and updates drug listing information within 30 days
after introduction of the drug. Requestors shall submit records
to the Secretary regarding minor changes within 15 days of such
request. If the Secretary determines the information in such
records is not sufficient, the Secretary will inform the
requestor in writing and provide with reasonable opportunity to
provide additional information. If the requestor fails to
provide necessary additional information, the drug as modified
will be an unapproved new drug and misbranded.
FDA shall issue administrative orders and guidance about
whether minor changes made by a requestor 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 by specific dosage forms. FDA will take into
account relevant public standards and may take into account
special needs of children in developing these orders and
guidance.
Reports of testing related to requestor-initiated
administrative orders will be kept confidential unless the
requestor consents to the disclosure. Other information, other
than raw data sets, submitted in support of the request shall
be made public on the date of the proposed order unless the
information is related to pharmaceutical quality. Information
provided to support a minor change will remain confidential.
Information submitted in a requestor-initiated process may be
withdrawn by the requestor before a proposed order under FDA
procedures.
Updates for changes to monograph drugs must be submitted to
FDA's drug listing system within 30 days of introduction or,
for drugs under a requestor-initiated administrative order,
prior to introduction into commerce.
This section does not preclude requestors from seeking new
drug approval, including under abbreviated new drug
applications. Determinations that a drug is GRASE constitute
findings of safety and effectiveness for the purposes of
section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), so that applicants only need to file information
needed to support the modification in a section 505(b)(2)
application.
FDA will establish a repository of administrative orders,
including interim final orders, in effect with their complete
text. FDA will list, at least annually, administrative orders
in development with FDA's current expectations for issuance
over a three-year period. FDA will also establish procedures
allowing requestors the opportunity for private meetings to
obtain advice on studies and information necessary to support
submissions, as well as procedures where there are multiple
sponsors or requestors on an administrative order. Submissions
will be in electronic format. Except as otherwise provided, FDA
will continue to use the existing notice and comment rulemaking
for rules that would apply to OTC drugs in general. Regulations
related to certain active ingredients in OTC drugs for certain
uses that are in effect prior to enactment shall be deemed to
be final. Regulations prior to enactment establishing
requirements for specific OTC drugs, such as labeling and
misbranding, are deemed to be final as they apply to the order
process of this section. FDA may make technical changes to
regulations that remain in effect to ensure conformity with
appropriate terminology and cross references. Finally, FDA will
issue guidance on meeting procedures and principles for
sponsors or requestors, the format and content of data
submissions, format of electronic formats, consolidated
proceedings, and recommendations on how to comply with order
requirements for on data to be kept on file for minor product
dosage form changes.
This section does not affect the current status of a
nonprescription drug marketed under a NDA or ANDA or that is
not subject to an administrative order. The Paperwork Reduction
Act will not apply to information collections under this
section, and administrative orders will not be subject to
Administrative Procedure Act rulemaking requirements.
Definitions for ``nonprescription drug,'' ``sponsor,'' and
``requestor'' are provided.
Section 102. Misbranding
Section 102 provides that monograph drugs not in compliance
or marketed from a non-fee paying facility are misbranded.
Section 103. Drugs excluded from the Over-the-Counter Drug Review
Section 103 provides that these sections do not apply to
nonprescription drugs FDA intentionally excluded from the OTC
Drug Review.
Section 104. Treatment of Sunscreen Innovation Act
Section 104 provides the sponsor of a proposed sunscreen
order under the Sunscreen Innovation Act (SIA) may elect to
remain under the SIA or may notify FDA that the order will
follow the process under Monograph reform. If in the Monograph
reform process, it will be deemed an order request accepted for
filing. Such election shall be made within 180 calendar days of
enactment. A final sunscreen order under SIA will be deemed a
final order. Sponsors may request confidential meetings, and
the Secretary shall convene such meeting within a reasonable
time period. The Secretary may refuse to grant additional
meetings if the Secretary determines that additional
confidential meetings are not reasonably necessary to advance a
proposed sunscreen order, or if the request fails to include
sufficient information upon which to base a substantive
conversation. The Secretary shall publish post-meeting
summaries. SIA sunsets at the end of fiscal year (FY) 2022.
Section 105. Update to Congress on appropriate pediatric indication for
certain OTC cough and cold drugs
Not later than one year after the date of enactment, and
annually thereafter, the Secretary must submit a letter to the
House Committee on Energy and Commerce and the Senate Committee
on Health, Education, Labor, and Pensions describing HHS'
progress in evaluating cough and cold monograph drugs for
children under age six until FDA submits a letter indicating it
has completed its evaluation and revised, as applicable, the
cough and cold monograph.
TITLE II--FEES RELATING TO MONOGRAPH DRUGS
Section 201. Short title; findings
Section 201 provides that the title may be cited as the
``Over-the-Counter Monograph User Fee Act of 2018.'' Congress
finds fees will be dedicated toward the nonprescription
monograph drug activities under goals identified in letters
from FDA to the committees of jurisdiction.
Section 202. Authority to access and use fees
Section 202 provides definitions, including ``OTC monograph
drug activities,'' ``OTC monograph drug facility,'' ``Contract
manufacturing organization,'' ``Tier 1 OTC monograph order
request,'' and ``Tier 2 OTC monograph order request.''
Section 202 authorizes FDA to assess and use OTC monograph
fees. Each person that owns a monograph drug facility on
December 31 or at any time in the preceding year shall be
assessed a facility fee unless the facility has ceased all
activities related to monograph drugs and updated its
registration to reflect such changes. Fees for contract
manufacturing organization facilities shall be equal to the
amount that is two-thirds of the fee for an OTC monograph drug
facility. For FY 2019, facility fees are due 45 days after FDA
publishes a notice on the fee amount. For fiscal years after
2019, fees are due on the later of June 1 or the first business
day after enactment of an appropriations Act providing for
collection.
Sponsor-initiated OTC monograph order requests are subject
to an inflation-adjusted $500,000 fee for Tier 1 requests, and
$100,000 for Tier 2 requests. Safety-related label change OTC
monograph order requests are exempt from the fee. Partial
refunds are possible for withdrawals before filing, before
substantial work was performed, or in tier reclassifications.
Before inflation adjustments or operating reserve
adjustments, target fee collections from facility fees would be
$22 million for FY 2018, $22 million for FY 2019, $25 million
for FY 2020, $31 million for FY 2021, and $34 million for FY
2022.
An inflation adjustment tied to the Consumer Price Index
(CPI) and related factors is included for fiscal years 2020-
2023. Carryover of unspent funds or for to cover excess work
may be held in an operating reserve with a maximum carry-over
of: three weeks' worth of fees in FY 2019, seven weeks in FY
2020, and ten weeks in FY 2021-23. Amounts over the maximum
would result in fee reductions the following year.
Based on facility assessments through drug registrations as
of December 31, FDA will set and publish the facility fee for
that fiscal year by January 31, with fees due before April 1.
Manufacturers must submit facility information each year
through drug establishment registration under existing section
510 of the FFDCA. Nonprescription monograph drug order requests
submitted by a sponsor or requestor not paying fees will be
considered incomplete, and ineligible for closed meetings. Fees
may be collected and available only to the extent provided in
appropriations Acts and available solely for nonprescription
monograph drug activities. Before FDA may spend fee revenue,
FDA must allocate $12 million year, adjusted for inflation.
Fees paid prior to the due date may be accepted, however, fees
not received by FDA after a grace period will be treated as a
U.S. Government claim. Full-time equivalent positions (FTEs) at
the Department of Health and Human Services not engaged in
monograph activities may not be construed to require an offset
from FTEs in monograph activities.
Starting in 2019, by February 1 of each year, FDA must
submit to Congress reports on its progress in meeting the goals
identified in the goals letter and future plans for meeting
such goals and the status of FDA's implementation of its fee
authority, fee uses, and collections. Such reports will be
posted on FDA's website.
FDA is directed to consult with Congress, scientific
experts, healthcare professionals, patient and advocacy groups,
and industry in preparing recommendations for Congress for
reauthorization beyond FY 2022. FDA must post a recommendations
report and take comments. FDA's final recommendations will be
sent to Congress no later than January 15, 2022.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, and existing law in which no
change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
misbranded drugs and devices
Sec. 502. A drug or device shall be deemed to be misbranded--
(a)(1) If its labeling is false or misleading in any
particular. Health care economic information provided to a
payor, formulary committee, or other similar entity with
knowledge and expertise in the area of health care economic
analysis, carrying out its responsibilities for the selection
of drugs for coverage or reimbursement, shall not be considered
to be false or misleading under this paragraph if the health
care economic information relates to an indication approved
under section 505 or under section 351(a) of the Public Health
Service Act for such drug, is based on competent and reliable
scientific evidence, and includes, where applicable, a
conspicuous and prominent statement describing any material
differences between the health care economic information and
the labeling approved for the drug under section 505 or under
section 351 of the Public Health Service Act. The requirements
set forth in section 505(a) or in subsections (a) and (k) of
section 351 of the Public Health Service Act shall not apply to
health care economic information provided to such a payor,
committee, or entity in accordance with this paragraph.
Information that is relevant to the substantiation of the
health care economic information presented pursuant to this
paragraph shall be made available to the Secretary upon
request.
(2)(A) For purposes of this paragraph, the term ``health care
economic information'' means any analysis (including the
clinical data, inputs, clinical or other assumptions, methods,
results, and other components underlying or comprising the
analysis) that identifies, measures, or describes the economic
consequences, which may be based on the separate or aggregated
clinical consequences of the represented health outcomes, of
the use of a drug. Such analysis may be comparative to the use
of another drug, to another health care intervention, or to no
intervention.
(B) Such term does not include any analysis that relates only
to an indication that is not approved under section 505 or
under section 351 of the Public Health Service Act for such
drug.
(b) If in a package form unless it bears a label containing
(1) the name and place of business of the manufacturer, packer,
or distributor; and (2) an accurate statement of the quantity
of the contents in terms of weight, measure, or numerical
count: Provided, That under clause (2) of this paragraph
reasonable variations shall be permitted, and exemptions as to
small packages shall be established, by regulations prescribed
by the Secretary.
(c) If any word, statement, or other information required by
or under authority of this Act to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to
render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
(e)(1)(A) If it is a drug, unless its label bears, to the
exclusion of any other nonproprietary name (except the
applicable systematic chemical name or the chemical formula)--
(i) the established name (as defined in subparagraph
(3)) of the drug, if there is such a name;
(ii) the established name and quantity or, if
determined to be appropriate by the Secretary, the
proportion of each active ingredient, including the
quantity, kind, and proportion of any alcohol, and also
including whether active or not the established name
and quantity or if determined to be appropriate by the
Secretary, the proportion of any bromides, ether,
chloroform, acetanilide, acetophenetidin, amidopyrine,
antipyrine, atropine, hyoscine, hyoscyamine, arsenic,
digitalis, digitalis glucosides, mercury, ouabain,
strophanthin, strychnine, thyroid, or any derivative or
preparation of any such substances, contained therein,
except that the requirement for stating the quantity of
the active ingredients, other than the quantity of
those specifically named in this subclause, shall not
apply to nonprescription drugs not intended for human
use; and
(iii) the established name of each inactive
ingredient listed in alphabetical order on the outside
container of the retail package and, if determined to
be appropriate by the Secretary, on the immediate
container, as prescribed in regulation promulgated by
the Secretary, except that nothing in this subclause
shall be deemed to require that any trade secret be
divulged, and except that the requirements of this
subclause with respect to alphabetical order shall
apply only to nonprescription drugs that are not also
cosmetics and that this subclause shall not apply to
nonprescription drugs not intended for human use.
(B) For any prescription drug the established name of such
drug or ingredient, as the case may be, on such label (and on
any labeling on which a name for such drug or ingredient is
used) shall be printed prominently and in type at least half as
large as that used thereon for any proprietary name or
designation for such drug or ingredient, except that to the
extent that compliance with the requirements of subclause (ii)
or (iii) of clause (A) or this clause is impracticable,
exemptions shall be established by regulations promulgated by
the Secretary.
(2) If it is a device and it has an established name, unless
its label bears, to the exclusion of any other nonproprietary
name, its established name (as defined in subparagraph (4))
prominently printed in type at least half as large as that used
thereon for any proprietary name or designation for such
device, except that to the extent compliance with the
requirements of this subparagraph is impracticable, exemptions
shall be established by regulations promulgated by the
Secretary.
(3) As used in subparagraph (1), the term ``established
name'', with respect to a drug or ingredient thereof, means (A)
the applicable official name designated pursuant to section
508, or (B) if there is no such name and such drug, or such
ingredient, is an article recognized in an official compendium,
then the official title thereof in such compendium, or (C) if
neither clause (A) nor clause (B) of this subparagraph applies,
then the common or usual name, if any, of such drug or of such
ingredient, except that where clause (B) of this subparagraph
applies to an article recognized in the United States
Pharmacopeia and in the Homeopathic Pharmacopeia under
different official titles, the official title used in the
United States Pharmacopeia shall apply unless it is labeled and
offered for sale as a homeopathic drug, in which case the
official title used in the Homeopathic Pharmacopeia shall
apply.
(4) As used in subparagraph (2), the term ``established
name'' with respect to a device means (A) the applicable
official name of the device designated pursuant to section 508,
(B) if there is no such name and such device is an article
recognized in an official compendium, then the official title
thereof in such compendium, or (C) if neither clause (A) nor
clause (B) of this subparagraph applies, then any common or
usual name of such device.
(f) Unless its labeling bears (1) adequate directions for
use; and (2) such adequate warnings against use in those
pathological conditions or by children where its use may be
dangerous to health, or against unsafe dosage or methods or
duration of administration or application, in such manner and
form, as are necessary for the protection of users, except that
where any requirement of clause (1) of this paragraph, as
applied to any drug or device, is not necessary for the
protection of the public health, the Secretary shall promulgate
regulations exempting such drug or device from such
requirement. Required labeling for prescription devices
intended for use in health care facilities or by a health care
professional and required labeling for in vitro diagnostic
devices intended for use by health care professionals or in
blood establishments may be made available solely by electronic
means, provided that the labeling complies with all applicable
requirements of law, and that the manufacturer affords such
users the opportunity to request the labeling in paper form,
and after such request, promptly provides the requested
information without additional cost.
(g) If it purports to be a drug the name of which is
recognized in an official compendium, unless it is packaged and
labeled as prescribed therein. The method of packing may be
modified with the consent of the Secretary. Whenever a drug is
recognized in both the United States Pharmacopeia and the
Homeopathic Pharmacopeia of the United States, it shall be
subject to the requirements of the United States Pharmacopeia
with respect to packaging, and labeling unless it is labeled
and offered for sale as a homeopathic drug, in which case it
shall be subject to the provisions of the Homeopathic
Pharmacopeia of the United States, and not to those of the
United States Pharmacopeia, except that in the event of
inconsistency between the requirements of this paragraph and
those of paragraph (e) as to the name by which the drug or its
ingredients shall be designated, the requirements of paragraph
(e) shall prevail.
(h) If it has been found by the Secretary to be a drug liable
to deterioration, unless it is packaged in such form and
manner, and its label bears a statement of such precautions, as
the Secretary shall by regulations require as necessary for the
protection of the public health. No such regulation shall be
established for any drug recognized in an official compendium
until the Secretary shall have informed the appropriate body
charged with the revision of such compendium of the need for
such packaging or labeling requirements and such body shall
have failed within a reasonable time to prescribe such
requirements.
(i)(1) If it is a drug and its container is so made, formed,
or filled as to be misleading; or (2) if it is an imitation of
another drug; or (3) if it is offered for sale under the name
of another drug.
(j) If it is dangerous to health when used in the dosage or
manner; or with the frequency or duration prescribed,
recommended, or suggested in the labeling thereof.
(m) If it is a color additive the intended use of which is
for the purpose of coloring only, unless its packaging and
labeling are in conformity with such packaging and labeling
requirements applicable to such color additive, as may be
contained in regulations issued under section 721.
(n) In the case of any prescription drug distributed or
offered for sale in any State, unless the manufacturer, packer,
or distributor thereof includes in all advertisements and other
descriptive printed matter issued or caused to be issued by the
manufacturer, packer, or distributor with respect to that drug
a true statement of (1) the established name as defined in
section 502(e), printed prominently and in type at least half
as large as that used for any trade or brand name thereof, (2)
the formula showing quantitatively each ingredient of such drug
to the extent required for labels under section 502(e), and (3)
such other information in brief summary relating to side
effects, contraindications, and effectiveness as shall be
required in regulations which shall be issued by the Secretary
in accordance with section 701(a), and in the case of published
direct-to-consumer advertisements the following statement
printed in conspicuous text: ``You are encouraged to report
negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.'', except that
(A) except in extraordinary circumstances, no regulation issued
under this paragraph shall require prior approval by the
Secretary of the content of any advertisement, and (B) no
advertisement of a prescription drug, published after the
effective date of regulations issued under this paragraph
applicable to advertisements of prescription drugs, shall, with
respect to the matters specified in this paragraph or covered
by such regulations, be subject to the provisions of sections
12 through 17 of the Federal Trade Commission Act, as amended
(15 U.S.C. 52-57). This paragraph (n) shall not be applicable
to any printed matter which the Secretary determines to be
labeling as defined in section 201(m) of this Act. Nothing in
the Convention on Psychotropic Substances, signed at Vienna,
Austria, on February 21, 1971, shall be construed to prevent
drug price communications to consumers. In the case of an
advertisement for a drug subject to section 503(b)(1) presented
directly to consumers in television or radio format and stating
the name of the drug and its conditions of use, the major
statement relating to side effects and contraindications shall
be presented in a clear, conspicuous, and neutral manner.
(o) If it was manufactured, prepared, propagated, compounded,
or processed in an establishment not duly registered under
section 510, if it is a drug and was imported or offered for
import by a commercial importer of drugs not duly registered
under section 801(s), if it was not included in a list required
by section 510(j), if a notice or other information respecting
it was not provided as required by such section or section
510(k), or if it does not bear such symbols from the uniform
system for identification of devices prescribed under section
510(e) as the Secretary by regulation requires.
(p) If it is a drug and its packaging or labeling is in
violation of an applicable regulation issued pursuant to
section 3 or 4 of the Poison Prevention Packaging Act of 1970.
(q) In the case of any restricted device distributed or
offered for sale in any State, if (1) its advertising is false
or misleading in any particular, or (2) it is sold,
distributed, or used in violation of regulations prescribed
under section 520(e).
(r) In the case of any restricted device distributed or
offered for sale in any State, unless the manufacturer, packer,
or distributor thereof includes in all advertisements and other
descriptive printed matter issued or caused to be issued by the
manufacturer, packer, or distributor with respect to that
device (1) a true statement of the device's established name as
defined in section 502(e), printed prominently and in type at
least half as large as that used for any trade or brand name
thereof, and (2) a brief statement of the intended uses of the
device and relevant warnings, precautions, side effects, and
contraindications and, in the case of specific devices made
subject to a finding by the Secretary after notice and
opportunity for comment that such action is necessary to
protect the public health, a full description of the components
of such device or the formula showing quantitatively each
ingredient of such device to the extent required in regulations
which shall be issued by the Secretary after an opportunity for
a hearing. Except in extraordinary circumstances, no regulation
issued under this paragraph shall require prior approval by the
Secretary of the content of any advertisement and no
advertisement of a restricted device, published after the
effective date of this paragraph shall, with respect to the
matters specified in this paragraph or covered by regulations
issued hereunder, be subject to the provisions of sections 12
through 15 of the Federal Trade Commission Act (15 U.S.C. 52-
55). This paragraph shall not be applicable to any printed
matter which the Secretary determines to be labeling as defined
in section 201(m).
(s) If it is a device subject to a performance standard
established under section 514, unless it bears such labeling as
may be prescribed in such performance standard.
(t) If it is a device and there was a failure or refusal (1)
to comply with any requirement prescribed under section 518
respecting the device, (2) to furnish any material or
information required by or under section 519 respecting the
device, or (3) to comply with a requirement under section 522.
(u)(1) Subject to paragraph (2), if it is a reprocessed
single-use device, unless it, or an attachment thereto,
prominently and conspicuously bears the name of the
manufacturer of the reprocessed device, a generally recognized
abbreviation of such name, or a unique and generally recognized
symbol identifying such manufacturer.
(2) If the original device or an attachment thereto does not
prominently and conspicuously bear the name of the manufacturer
of the original device, a generally recognized abbreviation of
such name, or a unique and generally recognized symbol
identifying such manufacturer, a reprocessed device may satisfy
the requirements of paragraph (1) through the use of a
detachable label on the packaging that identifies the
manufacturer and is intended to be affixed to the medical
record of a patient.
(v) If it is a reprocessed single-use device, unless all
labeling of the device prominently and conspicuously bears the
statement ``Reprocessed device for single use. Reprocessed by
__.'' The name of the manufacturer of the reprocessed device
shall be placed in the space identifying the person responsible
for reprocessing.
(w) If it is a new animal drug--
(1) that is conditionally approved under section 571
and its labeling does not conform with the approved
application or section 571(f), or that is not
conditionally approved under section 571 and its label
bears the statement set forth in section 571(f)(1)(A);
or
(2) that is indexed under section 572 and its
labeling does not conform with the index listing under
section 572(e) or 572(h), or that has not been indexed
under section 572 and its label bears the statement set
forth in section 572(h).
(x) If it is a nonprescription drug (as defined in section
760) that is marketed in the United States, unless the label of
such drug includes a domestic address or domestic phone number
through which the responsible person (as described in section
760) may receive a report of a serious adverse event (as
defined in section 760) with such drug.
(y) If it is a drug subject to an approved risk evaluation
and mitigation strategy pursuant to section 505(p) and the
responsible person (as such term is used in section 505-1)
fails to comply with a requirement of such strategy provided
for under subsection (d), (e), or (f) of section 505-1.
(z) If it is a drug, and the responsible person (as such term
is used in section 505(o)) is in violation of a requirement
established under paragraph (3) (relating to postmarket studies
and clinical trials) or paragraph (4) (relating to labeling) of
section 505(o) with respect to such drug.
(aa) If it is a drug, or an active pharmaceutical ingredient,
and it was manufactured, prepared, propagated, compounded, or
processed in a facility for which fees have not been paid as
required by section 744B(a)(4) or for which identifying
information required by section 744B(f) has not been submitted,
or it contains an active pharmaceutical ingredient that was
manufactured, prepared, propagated, compounded, or processed in
such a facility.
(bb) If the advertising or promotion of a compounded drug is
false or misleading in any particular.
(cc) If it is a drug and it fails to bear the product
identifier as required by section 582.
(dd) If it is an antimicrobial drug, as defined in section
511A(f), and its labeling fails to conform with the
requirements under section 511A(d).
(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. 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
(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.
(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);
(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 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.
* * * * * * *
Subchapter I--Nonprescription Sunscreen and Other Active Ingredients
* * * * * * *
SEC. 586C. GRASE DETERMINATION.
(a) Review of New Request.--
(1) Proposed sunscreen order.--In the case of a
request under section 586A, not later than 300 calendar
days after the date on which such request is filed
under subsection (b)(2)(A) or (b)(3)(B)(ii)(III) of
section 586B, the Secretary--
(A) may convene a meeting of the Advisory
Committee to review such request; and
(B) shall complete the review of such request
and issue a proposed sunscreen order with
respect to such request.
(2) Proposed sunscreen order by commissioner.--If the
Secretary does not issue a proposed sunscreen order
under paragraph (1)(B) within such 300-day period, the
sponsor of such request may notify the Office of the
Commissioner of such request and request review by the
Office of the Commissioner. If such sponsor so notifies
the Office of the Commissioner, the Commissioner shall,
not later than 60 calendar days after the date of
notification under this paragraph, issue a proposed
sunscreen order with respect to such request.
(3) Public comment period.--A proposed sunscreen
order issued under paragraph (1)(B) or (2) with respect
to a request shall provide for a period of 45 calendar
days for public comment.
(4) Meeting.--A sponsor may request, in writing, a
meeting with respect to a proposed sunscreen order
issued under this subsection and described in
subparagraph (B) or (C) of section 586(7), not later
than 30 calendar days after the Secretary issues such
order. The Secretary shall convene a meeting with such
sponsor not later than 45 calendar days after such
request for a meeting.
(5) Final sunscreen order.--With respect to a
proposed sunscreen order under paragraph (1)(B) or
(2)--
(A) the Secretary shall issue a final
sunscreen order--
(i) in the case of a proposed
sunscreen order described in
subparagraph (A) or (B) of section
586(7), not later than 90 calendar days
after the end of the public comment
period under paragraph (3); or
(ii) in the case of a proposed
sunscreen order described in
subparagraph (C) of section 586(7), not
later than 210 calendar days after the
date on which the sponsor submits the
additional information requested
pursuant to such proposed sunscreen
order; or
(B) if the Secretary does not issue such
final sunscreen order within such 90- or 210-
calendar-day period, as applicable, the sponsor
of such request may notify the Office of the
Commissioner of such request and request review
by the Office of the Commissioner.
(6) Final sunscreen order by commissioner.--The
Commissioner shall issue a final sunscreen order with
respect to a proposed sunscreen order subject to
paragraph (5)(B) not later than 60 calendar days after
the date of notification under such paragraph.
(b) Review of Pending Requests.--
(1) In general.--The review of a pending request
shall be carried out by the Secretary in accordance
with this subsection.
(2) Inapplicability of sections 586a and 586b.--
Sections 586A and 586B shall not apply with respect to
any pending request.
(3) Feedback letters as proposed sunscreen order.--
Notwithstanding the requirements of section 586(7), a
letter issued pursuant to section 330.14(g) of title
21, Code of Federal Regulations before the date of
enactment of the Sunscreen Innovation Act, with respect
to a pending request, shall be deemed to be a proposed
sunscreen order and displayed on the Internet website
of the Food and Drug Administration. Notification of
the availability of such letter shall be published in
the Federal Register not later than 45 calendar days
after the date of enactment of such Act.
(4) Proposed sunscreen order.--In the case of a
pending request for which the Secretary has not issued
a letter pursuant to section 330.14(g) of title 21,
Code of Federal Regulations before the date of
enactment of the Sunscreen Innovation Act, the
Secretary shall complete review of such request and,
not later than 90 calendar days after the date of
enactment of such Act, issue a proposed sunscreen order
with respect to such request.
(5) Proposed sunscreen order by commissioner.--If the
Secretary does not issue a proposed sunscreen order
under paragraph (4), or the Secretary does not publish
a notification of the availability of a letter under
paragraph (3), as applicable, the sponsor of such
request may notify the Office of the Commissioner of
such request and request review by the Office of the
Commissioner. The Commissioner shall, not later than 60
calendar days after the date of notification under this
paragraph, issue a proposed order with respect to such
request.
(6) Public comment period.--A proposed sunscreen
order issued under paragraph (4) or (5), or a
notification of the availability of a letter under
paragraph (3), with respect to a pending request shall
provide for a period of 45 calendar days for public
comment.
(7) Meeting.--[A sponsor may request]
(A) In general._A sponsor may request, in
writing, a meeting with respect to a proposed
sunscreen order issued under this subsection,
including a letter deemed to be a proposed
sunscreen order under paragraph (3), not later
than 30 calendar days after the Secretary
issues such order or the date upon which such
feedback letter is deemed to be a proposed
sunscreen order, as applicable. The Secretary
shall convene a meeting with such sponsor not
later than 45 calendar days after the date of
such request for a meeting.
(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.
(8) Advisory committee.--In the case of a proposed
sunscreen order under paragraph (3), (4), or (5), an
Advisory Committee meeting may be convened for the
purpose of reviewing and providing recommendations
regarding the pending request.
(9) Final sunscreen order.--In the case of a proposed
sunscreen order under paragraph (3), (4), or (5)--
(A) the Secretary shall issue a final
sunscreen order with respect to the request--
(i) in the case of a proposed
sunscreen order described in
subparagraph (A) or (B) of section
586(7), not later than 90 calendar days
after the end of the public comment
period under paragraph (6); or
(ii) in the case of a proposed
sunscreen order described in
subparagraph (C) of section 586(7)--
(I) if the Advisory Committee
is not convened under paragraph
(8), not later than 210
calendar days after the date on
which the sponsor submits the
additional information
requested pursuant to such
proposed sunscreen order, which
shall include a rationale for
not convening such Advisory
Committee; or
(II) if the Advisory
Committee is convened under
paragraph (8), not later than
270 calendar days after the
date on which the sponsor
submits such additional
information; or
(B) if the Secretary does not issue such
final sunscreen order within such 90-, 210-, or
270-calendar-day period, as applicable, the
sponsor of such request may notify the Office
of the Commissioner about such request and
request review by the Office of the
Commissioner.
(10) Final sunscreen order by commissioner.--The
Commissioner shall issue a final sunscreen order with
respect to a proposed sunscreen order subject to
paragraph (9)(B) not later than 60 calendar days after
the date of notification under such paragraph.
(c) Advisory Committee.--The Secretary shall not be required
to--
(1) convene the Advisory Committee--
(A) more than once with respect to any
request under section 586A or any pending
request; or
(B) more than twice in any calendar year with
respect to the review under this section; or
(2) submit more than a total of 3 requests under
section 586A or pending requests to the Advisory
Committee per meeting.
(d) No Delegation.--Any responsibility vested in the
Commissioner by subsection (a)(2), (a)(6), (b)(5), or (b)(10)
shall not be delegated.
(e) Effect of Final Sunscreen Order.--
(1) In general.--
(A) Sunscreen active ingredients determined
to be grase.--Upon issuance of a final
sunscreen order determining that a
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients is GRASE and is not misbranded, a
sunscreen containing such ingredient or
combination of ingredients shall be permitted
to be introduced or delivered into interstate
commerce for use under the conditions described
in such final sunscreen order, in accordance
with all requirements applicable to drugs not
subject to section 503(b)(1), for so long as
such final sunscreen order remains in effect.
(B) Sunscreen active ingredients determined
not to be grase.--Upon issuance of a final
sunscreen order determining that a
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients is not GRASE and is misbranded, a
sunscreen containing such ingredient or
combination of ingredients shall not be
introduced or delivered into interstate
commerce, for use under the conditions
described in such final sunscreen order, unless
an application is approved pursuant to section
505 with respect to a sunscreen containing such
ingredient or combination of ingredients, or
unless conditions are later established under
which such ingredient or combination of
ingredients is later determined to be GRASE and
not misbranded under the over-the-counter drug
monograph system.
(2) Amendments to final sunscreen orders.--
(A) Amendments at initiative of secretary.--
In the event that information relevant to a
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients becomes available to the Secretary
after issuance of a final sunscreen order, the
Secretary may amend such final sunscreen order
by issuing a new proposed sunscreen order under
subsection (a)(1) and following the procedures
set forth in this section.
(B) Petition to amend final order.--Any
interested person may petition the Secretary to
amend a final sunscreen order under section
10.30, title 21 Code of Federal Regulations (or
any successor regulations). If the Secretary
grants any petition under such section, the
Secretary shall initiate the process for
amending a final sunscreen order by issuing a
new proposed sunscreen order under subsection
(a)(1) and following the procedures set forth
in this section.
(C) Applicability of final orders.--Once the
Secretary issues a new proposed sunscreen order
to amend a final sunscreen order under
subparagraph (A) or (B), such final sunscreen
order shall remain in effect and paragraph (3)
shall not apply to such final sunscreen order
until the Secretary has issued a new final
sunscreen order or has determined not to amend
the final sunscreen order.
[(3) Inclusion of ingredients that are subjects of
final orders in the sunscreen monograph.--
[(A) Amending regulations.--
[(i) Requirement.--At any time that
the Secretary proposes to amend part
352 of title 21, Code of Federal
Regulations (or any successor
regulations) concerning nonprescription
sunscreen, including pursuant to
section 586E, except as provided in
clause (iv), the Secretary shall
include in such part 352 (or any
successor regulations) any
nonprescription sunscreen active
ingredient or combination of
nonprescription sunscreen active
ingredients that is the subject of an
effective final sunscreen order of the
type described in section 586(2)(A) and
issued since the time that the
Secretary last amended such
regulations. Such regulation shall set
forth conditions of use under which
each such ingredient or combination of
ingredients is GRASE and not
misbranded. If these conditions differ
from, or are in addition to, those
previously set forth in the applicable
final sunscreen order, the Secretary
shall provide notice and opportunity
for comment on such conditions in the
rulemaking, and the applicable final
sunscreen order shall continue in
effect until the effective date of a
final regulation, as set forth in
clause (iii).
[(ii) Inclusion of orders.--In
proposing to amend the regulations as
described in clause (i), the Secretary
shall include in the proposed
regulations a list of final sunscreen
orders that shall cease to be effective
on the effective date of a resulting
final regulation. Such list shall
include all final sunscreen orders of
the type described in section 586(2)(A)
that are in effect on the date that
such regulations are proposed, with the
exception that such list shall not
include any final sunscreen orders
that, on the date that the regulations
are proposed, the Secretary is in the
process of amending under paragraph
(2).
[(iii) Orders no longer effective.--
Any final sunscreen order included by
the Secretary in a list described in
clause (ii) and in a list included in
resulting final regulations shall cease
to be effective on the date that such
final regulations including such order
in such list become effective.
[(iv) Ingredients not grase.--If,
notwithstanding a final sunscreen order
stating that a nonprescription
sunscreen active ingredient or
combination of nonprescription
sunscreen active ingredients is GRASE
and is not misbranded if marketed in
accordance with such order, while
amending the regulations as described
in clause (i), the Secretary concludes
that such ingredient or combination of
ingredients is no longer GRASE for use
in nonprescription sunscreen, the
Secretary shall, at the discretion of
the Secretary, either initiate the
process for amending the final
sunscreen order set forth in paragraph
(2) of this subsection or include in a
proposed regulation an explanation and
information supporting the
determination of the Secretary that
such ingredient or combination of
ingredients is no longer GRASE for use
in nonprescription sunscreen.
[(B) Procedure for updating regulations.--
After the Secretary amends and finalizes the
regulations under part 352 of title 21, Code of
Federal Regulations under section 586E and such
regulations become effective, the Secretary may
use direct final rulemaking to include in such
regulations any nonprescription sunscreen
active ingredients that are the subject of
effective final sunscreen orders.]
(3) Relationship to orders under section 505g.--A
final sunscreen order shall be deemed to be a final
order under section 505G.
* * * * * * *
[SEC. 586E. SUNSCREEN MONOGRAPH.
[(a) In General.--Not later than 5 years after the date of
enactment of the Sunscreen Innovation Act, the Secretary shall
amend and finalize regulations under part 352 of title 21, Code
of Federal Regulations concerning nonprescription sunscreen
that are effective not later than 5 years after such date of
enactment. The Secretary shall publish such regulations not
less than 30 calendar days before the effective date of such
regulations.
[(b) Reports.--If the regulations promulgated under
subsection (a) do not include provisions related to the
effectiveness of various sun protection factor levels, and do
not address all dosage forms known to the Secretary to be used
in sunscreens marketed in the United States without a new drug
approval under section 505, the Secretary shall submit a report
to the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of the
House of Representatives on the rationale for such provisions
not being included in such regulations, and a plan and timeline
to compile any information necessary to address such provisions
through final regulations.]
* * * * * * *
SEC. 586H. SUNSET.
This subchapter shall cease to be effective at the end of
fiscal year 2022.
* * * * * * *
CHAPTER VII--GENERAL AUTHORITY
* * * * * * *
Subchapter C--Fees
* * * * * * *
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 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.
(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 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.
* * * * * * *
ADDITIONAL VIEWS
In addition to the creation of a user fee program for over-
the-counter (OTC) drugs, H.R. 5333 would transition the
regulatory process for OTC drugs from one that establishes the
safety and effectiveness of active ingredients through the
finalization of a monograph under rule-making to administrative
order. This streamlined process would also create a new pathway
that would allow OTC drug manufacturers to pursue innovative
changes to OTC drugs. This pathway would allow manufacturers to
initiate a request for the Food and Drug Administration (FDA)
to review a change in an active ingredient to a monograph, or
to establish a drug not currently in a monograph. If FDA finds
the drug or change in the monograph to be generally recognized
as safe and effective (GRASE), the manufacturer would be
rewarded with an exclusivity period of 18 months.
While I am supportive of the creation of the OTC user fee
program, as well as streamlining the safety and effectiveness
determination of OTC active ingredients from a rule-making
process to administrative order process, I have concerns about
the inclusion of an exclusivity reward for OTC drug
manufacturers. As we heard from Dr. Janet Woodcock, Director of
FDA's Center for Drug Evaluation and Research (CDER), FDA has
not been able to finalize many monographs to accommodate
product innovation or marketing changes and as a result there
has not been much innovation in the OTC market. More
specifically, the current rule-making process is not flexible
or nimble enough to accommodate advances in science or
innovation and has resulted in many manufacturers shelving
innovative ideas given the inability to bring them to market
under the current monograph process. H.R. 5333 works to address
this issue by creating a new pathway where manufacturers can
initiate changes to a monograph through the streamlined
administrative order process. This is an opportunity for
innovation that does not exist today. It is my hope and belief
that this new pathway will create an incentive for
manufacturers to innovate that does not exist today by
providing a timely and workable process for making changes to
an OTC monograph.
However, before implementing this new innovation pathway,
and before even understanding whether this new innovation
pathway is working to encourage innovation as Congress intends,
H.R. 5333 would also create an exclusivity reward to provide
OTC drug manufacturers with 18 months of exclusivity for
innovations found to be GRASE under this new pathway. Such a
step is not consistent with the creation of other user fee
programs. Congress has not generally contemplated the creation
of an exclusivity reward until it has been demonstrated that
the current regulatory landscape and marketplace are not
incentivizing needed innovation. For example, this was the case
when Congress extended six months of exclusivity to
manufacturers that conduct pediatric studies, and more recently
when Congress extended six months of exclusivity to generic
manufacturers that develop a competitor to current sole source
drug products. H.R. 5333 would abandon this precedent and would
award 18 months of exclusivity before any evidence is presented
that the industry-initiated innovation pathway has not been
sufficient in incentivizing innovation in the OTC drug market.
Supporters of this exclusivity award have made many
arguments as to why an exclusivity award may be necessary, such
as claims that negotiations with retailers may be lengthy or
that private label competition may begin right after an
innovative product is launched. However, there has been no
evidence that these arguments are justified, and further, there
has not been a compelling policy argument presented as to why
the new innovation pathway created under H.R. 5333 is not
sufficient on its own to incentivize innovation.
This Committee should take seriously the award of
exclusivity in any context, and examine closely any policy
proposal that holds the potential to keep affordable
medications off the market for an extended period of time.
While I have supported incentives in the past to encourage
certain development and innovation, it has been after a
compelling case has been made that the current marketplace and
regulatory pathways were not working sufficiently. In
considering such proposals, I have also always wanted to ensure
that the incentives would not burden or impede access to the
medications patients rely on. I do not believe that the current
inclusion of an 18-month exclusivity award in H.R. 5333 meets
this careful balance.
Frank Pallone, Jr.,
Ranking Member.