[Congressional Record Volume 164, Number 119 (Monday, July 16, 2018)]
[House]
[Pages H6227-H6237]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION, AND REFORM ACT OF 2018

  Mr. LATTA. Mr. Speaker, I move to suspend the rules and pass the bill 
(H.R. 5333) to amend the Federal Food, Drug, and Cosmetic Act to 
clarify the regulatory framework with respect to certain 
nonprescription drugs that are marketed without an approved new drug 
application, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 5333

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Over-the-Counter Monograph 
     Safety, Innovation, and Reform Act of 2018''.

                        TITLE I--OTC DRUG REVIEW

     SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT 
                   ARE MARKETED WITHOUT AN APPROVED NEW DRUG 
                   APPLICATION.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act is amended by inserting after section 505F of 
     such Act (21 U.S.C. 355g) the following:

     ``SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT 
                   ARE MARKETED WITHOUT AN APPROVED NEW DRUG 
                   APPLICATION.

       ``(a) Nonprescription Drugs Marketed Without an Approved 
     Application.--Nonprescription drugs marketed without an 
     approved new drug application under section 505, as of the 
     date of the enactment of the Over-the-Counter Monograph 
     Safety, Innovation, and Reform Act of 2018, shall be treated 
     in accordance with this subsection.
       ``(1) Drugs subject to a final monograph; category i drugs 
     subject to a tentative final monograph.--A drug is deemed to 
     be generally recognized as safe and effective within the 
     meaning of section 201(p)(1), not a new drug under section 
     201(p), and not subject to section 503(b)(1), if--
       ``(A) the drug is--
       ``(i) in conformity with the requirements for 
     nonprescription use of a final monograph issued under part 
     330 of title 21, Code of Federal Regulations (except as 
     provided in paragraph (2)), the general requirements for 
     nonprescription drugs, and requirements under subsections 
     (b), (c), and (k); and
       ``(ii) except as permitted by an order issued under 
     subsection (b) or, in the case of a minor change in the drug, 
     in conformity with an order issued under subsection (c), in a 
     dosage form that, immediately prior to the date of the 
     enactment of this section, has been used to a material extent 
     and for a material time within the meaning of section 
     201(p)(2); or
       ``(B) the drug is--
       ``(i) classified in category I for safety and effectiveness 
     under a tentative final monograph that is the most recently 
     applicable proposal or determination issued under part 330 of 
     title 21, Code of Federal Regulations;
       ``(ii) in conformity with the proposed requirements for 
     nonprescription use of such tentative final monograph, any 
     applicable subsequent determination by the Secretary, the 
     general requirements for nonprescription drugs, and 
     requirements under subsections (b), (c), and (k); and
       ``(iii) except as permitted by an order issued under 
     subsection (b) or, in the case of a minor change in the drug, 
     in conformity with an order issued under subsection (c), in a 
     dosage form that, immediately prior to the date of the 
     enactment of this section, has been used to a material extent 
     and for a material time within the meaning of section 
     201(p)(2).
       ``(2) Treatment of sunscreen drugs.--With respect to 
     sunscreen drugs subject to this section, the applicable 
     requirements shall be the requirements specified in part 352 
     of title 21, Code of Federal Regulations, as published on May 
     21, 1999, beginning on page 27687 of volume 64 of the Federal 
     Register, except that the applicable requirements governing 
     effectiveness and labeling shall be those specified in 
     section 201.327 of title 21, Code of Federal Regulations, 
     subject to the requirements of subsections (b), (c), and (k).
       ``(3) Category iii drugs subject to a tentative final 
     monograph; category i drugs subject to proposed monograph or 
     advance notice of proposed rulemaking.--A drug that is not 
     described in paragraphs (1), (2), or (4) is not required to 
     be the subject of an application approved under section 505, 
     and is not subject to section 503(b)(1), if--
       ``(A) the drug is--
       ``(i) classified in category III for safety or 
     effectiveness in the preamble of a proposed rule establishing 
     a tentative final monograph that is the most recently 
     applicable proposal or determination for such drug issued 
     under part 330 of title 21, Code of Federal Regulations;
       ``(ii) in conformity with--

       ``(I) the conditions of use, including indication and 
     dosage strength, if any, described for such category III drug 
     in such preamble or in an applicable subsequent proposed 
     rule;
       ``(II) the proposed requirements for drugs classified in 
     such tentative final monograph in category I in the most 
     recently proposed rule establishing requirements related to 
     such tentative final monograph and in any final rule 
     establishing requirements that are applicable to the drug; 
     and

[[Page H6228]]

       ``(III) the general requirements for nonprescription drugs 
     and requirements under subsections (b) or (k); and

       ``(iii) in a dosage form that, immediately prior to the 
     date of the enactment of this section, was not required to 
     have satisfied the requirements of section 330.14 of title 
     21, Code of Federal Regulations (as in effect at that time), 
     in order for such drug to be lawfully marketed without an 
     application approved under section 505; or
       ``(B) the drug is--
       ``(i) classified in category I for safety and effectiveness 
     under a proposed monograph or advance notice of proposed 
     rulemaking that is the most recently applicable proposal or 
     determination for such drug issued under part 330 of title 
     21, Code of Federal Regulations;
       ``(ii) in conformity with the requirements for 
     nonprescription use of such proposed monograph or advance 
     notice of proposed rulemaking, any applicable subsequent 
     determination by the Secretary, the general requirements for 
     nonprescription drugs, and requirements under subsections (b) 
     or (k); and
       ``(iii) in a dosage form that, immediately prior to the 
     date of the enactment of this section, has been used to a 
     material extent and for a material time within the meaning of 
     section 201(p)(2).
       ``(4) Category ii drugs deemed new drugs.--A drug that is 
     classified in category II for safety or effectiveness under a 
     tentative final monograph or that is subject to a 
     determination to be not safe or effective in a proposed rule 
     that is the most recently applicable proposal issued under 
     part 330 of title 21, Code of Federal Regulations, shall be 
     deemed to be a new drug within the meaning of section 201(p), 
     misbranded under section 502(ee), and subject to the 
     requirement for an approved new drug application under 
     section 505 beginning on the day that is 180 calendar days 
     after the date of the enactment of this section, unless, 
     before such day, the Secretary determines that it is in the 
     interest of public health to extend the period during which 
     the drug may be marketed without such an approved new drug 
     application.
       ``(5) Drugs not grase deemed new drugs.--A drug that the 
     Secretary has determined not to be generally recognized as 
     safe and effective within the meaning of section 201(p)(1) 
     under a final determination issued under part 330 of title 
     21, Code of Federal Regulations, shall be deemed to be a new 
     drug within the meaning of section 201(p), misbranded under 
     section 502(ee), and subject to the requirement for an 
     approved new drug application under section 505.
       ``(6) Other drugs deemed new drugs.--Except as provided in 
     subsection (m), a drug is deemed to be a new drug within the 
     meaning of section 201(p) and misbranded under section 
     502(ee) if the drug--
       ``(A) is not subject to section 503(b)(1); and
       ``(B) is not described in paragraphs (1), (2), (3), (4), or 
     (5), or subsection (b)(1)(B).
       ``(b) Administrative Orders.--
       ``(1) In general.--
       ``(A) Determination.--The Secretary may, on the initiative 
     of the Secretary or at the request of one or more requestors, 
     issue administrative orders determining whether there are 
     conditions under which specific drugs, classes of such drugs, 
     or combinations of such drugs are determined to be--
       ``(i) not subject to section 503(b)(1); and
       ``(ii) generally recognized as safe and effective within 
     the meaning of section 201(p)(1).
       ``(B) Effect.--A drug or combination of drugs shall be 
     deemed to not require approval under section 505 if such drug 
     or combination of drugs--
       ``(i) is determined by the Secretary to meet the conditions 
     specified in clauses (i) and (ii) of subparagraph (A);
       ``(ii) is marketed in conformity with an administrative 
     order under this subsection;
       ``(iii) meets the general requirements for nonprescription 
     drugs; and
       ``(iv) meets the requirements under subsections (c) and 
     (k).
       ``(C) Standard.--The Secretary shall find that a drug is 
     not generally recognized as safe and effective within the 
     meaning of section 201(p)(1) if--
       ``(i) the evidence shows that the drug is not generally 
     recognized as safe and effective within the meaning of 
     section 201(p)(1); or
       ``(ii) the evidence is inadequate to show that the drug is 
     generally recognized as safe and effective within the meaning 
     of section 201(p)(1).
       ``(2) Administrative orders initiated by the secretary.--
       ``(A) In general.--In issuing an administrative order under 
     paragraph (1) upon the Secretary's initiative, the Secretary 
     shall--
       ``(i) make reasonable efforts to notify informally, not 
     later than 2 business days before the issuance of the 
     proposed order, the sponsors of drugs who have a listing in 
     effect under section 510(j) for the drugs or combination of 
     drugs that will be subject to the administrative order;
       ``(ii) after any such reasonable efforts of notification--

       ``(I) issue a proposed administrative order by publishing 
     it on the website of the Food and Drug Administration and 
     include in such order the reasons for the issuance of such 
     order; and
       ``(II) publish a notice of availability of such proposed 
     order in the Federal Register;

       ``(iii) except as provided in subparagraph (B), provide for 
     a public comment period with respect to such proposed order 
     of not less than 45 calendar days; and
       ``(iv) if, after completion of the proceedings specified in 
     clauses (i) through (iii), the Secretary determines that it 
     is appropriate to issue a final administrative order--

       ``(I) issue the final administrative order, together with a 
     detailed statement of reasons, which order shall not take 
     effect until the time for requesting judicial review under 
     paragraph (3)(D)(ii) has expired;
       ``(II) publish a notice of such final administrative order 
     in the Federal Register;
       ``(III) afford requestors of drugs that will be subject to 
     such order the opportunity for formal dispute resolution up 
     to the level of the Director of the Center for Drug 
     Evaluation and Research, which initially must be requested 
     within 45 calendar days of the issuance of the order, and, 
     for subsequent levels of appeal, within 30 calendar days of 
     the prior decision; and
       ``(IV) except with respect to drugs described in paragraph 
     (3)(B), upon completion of the formal dispute resolution 
     procedure, inform the persons which sought such dispute 
     resolution of their right to request a hearing.

       ``(B) Exceptions.--When issuing an administrative order 
     under paragraph (1) on the Secretary's initiative proposing 
     to determine that a drug described in subsection (a)(3) is 
     not generally recognized as safe and effective within the 
     meaning of section 201(p)(1), the Secretary shall follow the 
     procedures in subparagraph (A), except that--
       ``(i) the proposed order shall include notice of--

       ``(I) the general categories of data the Secretary has 
     determined necessary to establish that the drug is generally 
     recognized as safe and effective within the meaning of 
     section 201(p)(1); and
       ``(II) the format for submissions by interested persons;

       ``(ii) the Secretary shall provide for a public comment 
     period of no less than 180 calendar days with respect to such 
     proposed order, except when the Secretary determines, for 
     good cause, that a shorter period is in the interests of 
     public health; and
       ``(iii) any person who submits data in such comment period 
     shall include a certification that the person has submitted 
     all evidence created, obtained, or received by that person 
     that is both within the categories of data identified in the 
     proposed order and relevant to a determination as to whether 
     the drug is generally recognized as safe and effective within 
     the meaning of section 201(p)(1).
       ``(3) Hearings; judicial review.--
       ``(A) In general.--Only a person who participated in each 
     stage of formal dispute resolution under subclause (III) of 
     paragraph (2)(A)(iv) of an administrative order with respect 
     to a drug may request a hearing concerning a final 
     administrative order issued under such paragraph with respect 
     to such drug. Such person must submit a request for a 
     hearing, which shall be based solely on information in the 
     administrative record, to the Secretary not later than 30 
     calendar days after receiving notice of the final decision of 
     the formal dispute resolution procedure.
       ``(B) No hearing required with respect to orders relating 
     to certain drugs.--
       ``(i) In general.--The Secretary shall not be required to 
     provide notice and an opportunity for a hearing pursuant to 
     paragraph (2)(A)(iv) if the final administrative order 
     involved relates to a drug--

       ``(I) that is described in subsection (a)(3)(A); and
       ``(II) with respect to which no human or non-human data 
     studies relevant to the safety or effectiveness of such drug 
     have been submitted to the administrative record since the 
     issuance of the most recent tentative final monograph 
     relating to such drug.

       ``(ii) Human data studies and non-human data defined.--In 
     this subparagraph:

       ``(I) The term `human data studies' means clinical trials 
     of safety or effectiveness (including actual use studies), 
     pharmacokinetics studies, or bioavailability studies.
       ``(II) The term `non-human data' means data from testing 
     other than with human subjects which provides information 
     concerning safety or effectiveness.

       ``(C) Hearing procedures.--
       ``(i) Denial of request for hearing.--If the Secretary 
     determines that information submitted in a request for a 
     hearing under subparagraph (A) with respect to a final 
     administrative order issued under paragraph (2)(A)(iv), does 
     not identify the existence of a genuine and substantial 
     question of material fact, the Secretary may deny such 
     request. In making such a determination, the Secretary may 
     consider only information and data that are based on relevant 
     and reliable scientific principles and methodologies.
       ``(ii) Single hearing for multiple related requests.--If 
     more than one request for a hearing is submitted with respect 
     to the same administrative order under subparagraph (A), the 
     Secretary may direct that a single hearing be conducted in 
     which all persons whose hearing requests were granted may 
     participate.
       ``(iii) Presiding officer.--The presiding officer of a 
     hearing requested under subparagraph (A) shall--

       ``(I) be designated by the Secretary;
       ``(II) not be an employee of the Center for Drug Evaluation 
     and Research; and
       ``(III) not have been previously involved in the 
     development of the administrative order involved or 
     proceedings relating to that administrative order.

       ``(iv) Rights of parties to hearing.--The parties to a 
     hearing requested under subparagraph (A) shall have the right 
     to present testimony, including testimony of expert 
     witnesses, and to cross-examine witnesses presented by other 
     parties. Where appropriate, the presiding officer may require 
     that cross-examination by parties representing substantially 
     the same interests be consolidated to promote efficiency and 
     avoid duplication.
       ``(v) Final decision.--

       ``(I) At the conclusion of a hearing requested under 
     subparagraph (A), the presiding officer of the hearing shall 
     issue a decision containing findings of fact and conclusions 
     of law. The decision of the presiding officer shall be final.
       ``(II) The final decision may not take effect until the 
     period under subparagraph (D)(ii) for submitting a request 
     for judicial review of such decision expires.

[[Page H6229]]

       ``(D) Judicial review of final administrative order.--
       ``(i) In general.--The procedures described in section 
     505(h) shall apply with respect to judicial review of final 
     administrative orders issued under this subsection in the 
     same manner and to the same extent as such section applies to 
     an order described in such section except that the judicial 
     review shall be taken by filing in an appropriate district 
     court of the United States in lieu of the appellate courts 
     specified in such section.
       ``(ii) Period to submit a request for judicial review.--A 
     person eligible to request a hearing under this paragraph and 
     seeking judicial review of a final administrative order 
     issued under this subsection shall file such request for 
     judicial review not later than 60 calendar days after the 
     latest of--

       ``(I) the date on which notice of such order is published;
       ``(II) the date on which a hearing with respect to such 
     order is denied under subparagraph (B) or (C)(i);
       ``(III) the date on which a final decision is made 
     following a hearing under subparagraph (C)(v); or
       ``(IV) if no hearing is requested, the date on which the 
     time for requesting a hearing expires.

       ``(4) Expedited procedure with respect to administrative 
     orders initiated by the secretary.--
       ``(A) Imminent hazard to the public health.--
       ``(i) In general.--In the case of a determination by the 
     Secretary that a drug, class of drugs, or combination of 
     drugs subject to this section poses an imminent hazard to the 
     public health, the Secretary, after first making reasonable 
     efforts to notify, not later than 48 hours before issuance of 
     such order under this subparagraph, sponsors who have a 
     listing in effect under section 510(j) for such drug or 
     combination of drugs--

       ``(I) may issue an interim final administrative order for 
     such drug, class of drugs, or combination of drugs under 
     paragraph (1), together with a detailed statement of the 
     reasons for such order;
       ``(II) shall publish in the Federal Register a notice of 
     availability of any such order; and
       ``(III) shall provide for a public comment period of at 
     least 45 calendar days with respect to such interim final 
     order.

       ``(ii) Nondelegation.--The Secretary may not delegate the 
     authority to issue an interim final administrative order 
     under this subparagraph.
       ``(B) Safety labeling changes.--
       ``(i) In general.--In the case of a determination by the 
     Secretary that a change in the labeling of a drug, class of 
     drugs, or combination of drugs subject to this section is 
     reasonably expected to mitigate a significant or unreasonable 
     risk of a serious adverse event associated with use of the 
     drug, the Secretary may--

       ``(I) make reasonable efforts to notify informally, not 
     later than 48 hours before the issuance of the interim final 
     order, the sponsors of drugs who have a listing in effect 
     under section 510(j) for such drug or combination of drugs;
       ``(II) after reasonable efforts of notification, issue an 
     interim final administrative order in accordance with 
     paragraph (1) to require such change, together with a 
     detailed statement of the reasons for such order;
       ``(III) publish in the Federal Register a notice of 
     availability of such order; and
       ``(IV) provide for a public comment period of at least 45 
     calendar days with respect to such interim final order.

       ``(ii) Content of order.--An interim final order issued 
     under this subparagraph with respect to the labeling of a 
     drug may provide for new warnings and other information 
     required for safe use of the drug.
       ``(C) Effective date.--An order under subparagraph (A) or 
     (B) shall take effect on a date specified by the Secretary.
       ``(D) Final order.--After the completion of the proceedings 
     in subparagraph (A) or (B), the Secretary shall--
       ``(i) issue a final order in accordance with paragraph (1);
       ``(ii) publish a notice of availability of such final 
     administrative order in the Federal Register; and
       ``(iii) afford sponsors of such drugs that will be subject 
     to such an order the opportunity for formal dispute 
     resolution up to the level of the Director of the Center for 
     Drug Evaluation and Research, which must initially be within 
     45 calendar days of the issuance of the order, and for 
     subsequent levels of appeal, within 30 calendar days of the 
     prior decision.
       ``(E) Hearings.--A sponsor of a drug subject to a final 
     order issued under subparagraph (D) and that participated in 
     each stage of formal dispute resolution under clause (iii) of 
     such subparagraph may request a hearing on such order. The 
     provisions of subparagraphs (A), (B), and (C) of paragraph 
     (3), other than paragraph (3)(C)(v)(II), shall apply with 
     respect to a hearing on such order in the same manner and to 
     the same extent as such provisions apply with respect to a 
     hearing on an administrative order issued under paragraph 
     (2)(A)(iv).
       ``(F) Timing.--
       ``(i) Final order and hearing.--The Secretary shall--

       ``(I) not later than 6 months after the date on which the 
     comment period closes under subparagraph (A) or (B), issue a 
     final order in accordance with paragraph (1); and
       ``(II) not later than 12 months after the date on which 
     such final order is issued, complete any hearing under 
     subparagraph (E).

       ``(ii) Dispute resolution request.--The Secretary shall 
     specify in an interim final order issued under subparagraph 
     (A) or (B) such shorter periods for requesting dispute 
     resolution under subparagraph (D)(iii) as are necessary to 
     meet the requirements of this subparagraph.
       ``(G) Judicial review.--A final order issued pursuant to 
     subparagraph (F) shall be subject to judicial review in 
     accordance with paragraph (3)(D).
       ``(5) Administrative order initiated at the request of a 
     requestor.--
       ``(A) In general.--In issuing an administrative order under 
     paragraph (1) at the request of a requestor with respect to 
     certain drugs, classes of drugs, or combinations of drugs--
       ``(i) the Secretary shall, after receiving a request under 
     this subparagraph, determine whether the request is 
     sufficiently complete and formatted to permit a substantive 
     review;
       ``(ii) if the Secretary determines that the request is 
     sufficiently complete and formatted to permit a substantive 
     review, the Secretary shall--

       ``(I) file the request; and
       ``(II) initiate proceedings with respect to issuing an 
     administrative order in accordance with paragraphs (2) and 
     (3); and

       ``(iii) except as provided in paragraph (6), if the 
     Secretary determines that a request does not meet the 
     requirements for filing or is not sufficiently complete and 
     formatted to permit a substantive review, the requestor may 
     demand that the request be filed over protest, and the 
     Secretary shall initiate proceedings to review the request in 
     accordance with paragraph (2)(A).
       ``(B) Request to initiate proceedings.--
       ``(i) In general.--A requestor seeking an administrative 
     order under paragraph (1) with respect to certain drugs, 
     classes of drugs, or combinations of drugs, shall submit to 
     the Secretary a request to initiate proceedings for such 
     order in the form and manner as specified by the Secretary. 
     Such requestor may submit a request under this subparagraph 
     for the issuance of an administrative order--

       ``(I) determining whether a drug is generally recognized as 
     safe and effective within the meaning of section 201(p)(1), 
     exempt from section 503(b)(1), and not required to be the 
     subject of an approved application under section 505; or
       ``(II) determining whether a change to a condition of use 
     of a drug is generally recognized as safe and effective 
     within the meaning of section 201(p)(1), exempt from section 
     503(b)(1), and not required to be the subject of an approved 
     application under section 505, if, absent such a changed 
     condition of use, such drug is--

       ``(aa) generally recognized as safe and effective within 
     the meaning of section 201(p)(1) in accordance with 
     subsection (a)(1), (a)(2), or an order under this subsection; 
     or
       ``(bb) subject to subsection (a)(3), but only if such 
     requestor initiates such request in conjunction with a 
     request for the Secretary to determine whether such drug is 
     generally recognized as safe and effective within the meaning 
     of section 201(p)(1), which is filed by the Secretary under 
     subparagraph (A)(ii).
       ``(ii) Exception.--The Secretary is not required to 
     complete review of a request for a change described in clause 
     (i)(II) if the Secretary determines that there is an 
     inadequate basis to find the drug is generally recognized as 
     safe and effective within the meaning of section 201(p)(1) 
     under paragraph (1) and issues a final order announcing that 
     determination.
       ``(iii) Withdrawal.--The requestor may withdraw a request 
     under this paragraph, according to the procedures set forth 
     pursuant to subsection (d)(2)(B). Notwithstanding any other 
     provision of this section, if such request is withdrawn, the 
     Secretary may cease proceedings under this subparagraph.
       ``(C) Exclusivity.--
       ``(i) In general.--A final administrative order issued in 
     response to a request under this section shall have the 
     effect of authorizing solely the order requestor (or the 
     licensees, assignees, or successors in interest of such 
     requestor with respect to the subject of such order), for a 
     period of 18 months following the effective date of such 
     final order, to market drugs--

       ``(I) incorporating changes described in clause (ii);
       ``(II) beginning on the date the requestor (or any such 
     licensees, assignees, or successors in interest) may lawfully 
     market such drugs pursuant to the order; and
       ``(III) subject to the limitations under clause (iv).

       ``(ii) Changes described.--A change described in this 
     clause is a change subject to an order specified in clause 
     (i), which--

       ``(I) provides for a drug to contain an active ingredient 
     (including any ester or salt of the active ingredient) not 
     previously incorporated in a drug described in clause (iii); 
     or
       ``(II) provides for a change in the conditions of use of a 
     drug, for which new human data studies conducted or sponsored 
     by the requestor (or for which the requestor has an exclusive 
     right of reference) were essential to the issuance of such 
     order.

       ``(iii) Drugs described.--The drugs described in this 
     clause are drugs--

       ``(I) specified in subsection (a)(1), (a)(2), or (a)(3);
       ``(II) subject to a final order issued under this section;
       ``(III) subject to a final sunscreen order (as defined in 
     section 586(2)(A)); or
       ``(IV) described in subsection (m)(1), other than drugs 
     subject to an active enforcement action under chapter III of 
     this Act.

       ``(iv) Limitations on exclusivity.--

       ``(I) In general.--Only one period of exclusivity shall be 
     granted, under each order described in clause (i), with 
     respect to changes (to the drug subject to such order) which 
     are either--

       ``(aa) changes described in clause (ii)(I), relating to 
     active ingredients; or
       ``(bb) changes described in clause (ii)(II), relating to 
     conditions of use.

       ``(II) No exclusivity allowed.--No exclusivity shall apply 
     to changes to a drug which are--

       ``(aa) the subject of a Tier 2 OTC monograph order request 
     (as defined in section 744N);

[[Page H6230]]

       ``(bb) safety-related changes, as defined by the Secretary, 
     or any other changes the Secretary considers necessary to 
     assure safe use; or
       ``(cc) changes related to methods of testing safety or 
     efficacy.
       ``(v) New human data studies defined.--In this 
     subparagraph, the term `new human data studies' means 
     clinical trials of safety or effectiveness (including actual 
     use studies), pharmacokinetics studies, or bioavailability 
     studies, the results of which--

       ``(I) have not been relied on by the Secretary to support--

       ``(aa) a proposed or final determination that a drug 
     described in subclauses (I), (II), or (III) of clause (iii) 
     is generally recognized as safe and effective within the 
     meaning of section 201(p)(1); or
       ``(bb) approval of a drug that was approved under section 
     505; and

       ``(II) do not duplicate the results of another study that 
     was relied on by the Secretary to support--

       ``(aa) a proposed or final determination that a drug 
     described in subclauses (I), (II), or (III) of clause (iii) 
     is generally recognized as safe and effective within the 
     meaning of section 201(p)(1); or
       ``(bb) approval of a drug that was approved under section 
     505.
       ``(vi) Effective date.--A final order subject to clause (i) 
     shall take effect on the date when the order requestor (or 
     the licensees, assignees, or successors in interest of such 
     requestor with respect to such order) submits updated drug 
     listing information under subsection (e) with respect to the 
     change which is permitted under such order.
       ``(vii) GAO study.--Not later than 4 years after the date 
     of enactment of the Over-the-Counter Monograph, Safety, 
     Innovation, and Reform Act of 2018, the Comptroller General 
     of the United States shall submit a study to the Committee on 
     Energy and Commerce of the House of Representatives and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate addressing the effectiveness and overall impact of 
     exclusivity under this section, including its impact on 
     consumer access. Such study shall include--

       ``(I) the number of nonprescription drug products that were 
     granted exclusivity and the indication for which the 
     nonprescription drug products were determined to be generally 
     recognized as safe and effective;
       ``(II) whether the exclusivity for such drug products was 
     granted for--

       ``(aa) a new active ingredient (including any ester or salt 
     of the active ingredient); or
       ``(bb) changes in the conditions of use of a drug, for 
     which new human data studies conducted or sponsored by the 
     requestor were essential;

       ``(III) whether, and to what extent, the exclusivity 
     impacted the requestor's or sponsor's decision to develop the 
     drug product;
       ``(IV) an analysis of the implementation of the exclusivity 
     provision in this subparagraph, including--

       ``(aa) the resources used by the Food and Drug 
     Administration;
       ``(bb) the impact of such provision on innovation, as well 
     as research and development in the nonprescription drug 
     market;
       ``(cc) the impact of such provision on competition in the 
     nonprescription drug market;
       ``(dd) the impact of such provision on consumer access to 
     nonprescription drug products;
       ``(ee) the impact of such provision on the prices of 
     nonprescription drug products; and
       ``(ff) whether the administrative orders initiated by 
     requestors under this section have been sufficient to 
     encourage the development of nonprescription drug products 
     that would likely not be otherwise developed, or developed in 
     as timely a manner; and

       ``(V) whether the administrative orders initiated by 
     requestors under this section have been sufficient incentive 
     to encourage innovation in the nonprescription drug market.

       ``(6) Information regarding safe nonprescription marketing 
     and use as condition for filing a generally recognized as 
     safe and effective request.--
       ``(A) In general.--In response to a request under this 
     section that a drug described in subparagraph (B) be 
     generally recognized as safe and effective, the Secretary--
       ``(i) may file such request, if the request includes 
     information specified under subparagraph (C) with respect to 
     safe nonprescription marketing and use of such drug; or
       ``(ii) if the request fails to include information 
     specified under subparagraph (C), shall refuse to file such 
     request and require that nonprescription marketing of the 
     drug be pursuant to a new drug application as described in 
     subparagraph (D).
       ``(B) Drug described.--A drug described in this 
     subparagraph is a nonprescription drug which contains an 
     active ingredient not previously incorporated in a drug--
       ``(i) specified in subsection (a)(1), (a)(2), or (a)(3);
       ``(ii) subject to a final order under this section; or
       ``(iii) subject to a final sunscreen order (as defined in 
     section 586(2)(A)).
       ``(C) Information demonstrating prima facie safe 
     nonprescription marketing and use.--Information specified in 
     this subparagraph, with respect to a request described in 
     subparagraph (A)(i), is--
       ``(i) information sufficient for a prima facie 
     demonstration that the drug subject to such request has a 
     verifiable history of being marketed and safely used by 
     consumers in the United States as a nonprescription drug 
     under comparable conditions of use;
       ``(ii) if the drug has not been previously marketed in the 
     United States as a nonprescription drug, information 
     sufficient for a prima facie demonstration that the drug was 
     marketed and safely used under comparable conditions of 
     marketing and use in a country listed in section 802(b)(1)(A) 
     or designated by the Secretary in accordance with section 
     802(b)(1)(B)--

       ``(I) for such period of time as needed to provide 
     reasonable assurances concerning the safe nonprescription use 
     of the drug; and
       ``(II) during such time was subject to sufficient 
     monitoring by a regulatory body considered acceptable by the 
     Secretary for such monitoring purposes, including for adverse 
     events associated with nonprescription use of the drug; or

       ``(iii) if the Secretary determines that information 
     described in clauses (i) or (ii) is not needed to provide a 
     prima facie demonstration that the drug can be safely 
     marketed and used as a nonprescription drug, such other 
     information the Secretary determines is sufficient for such 
     purposes.
       ``(D) Marketing pursuant to new drug application.--In the 
     case of a request described in subparagraph (A)(ii), the drug 
     subject to such request may be re-submitted for filing only 
     if--
       ``(i) the drug is marketed as a nonprescription drug, under 
     conditions of use comparable to the conditions specified in 
     the request, for such period of time as the Secretary 
     determines appropriate (not to exceed five consecutive years) 
     pursuant to an application approved under section 505; and
       ``(ii) during such time period, one million retail packages 
     of the drug, or an equivalent quantity as determined by the 
     Secretary, were distributed for retail sale, as determined in 
     such manner as the Secretary finds appropriate.
       ``(E) Rule of application.--Except in the case of a request 
     involving a drug described in section 586(9), as in effect on 
     January 1, 2017, if the Secretary refuses to file a request 
     under this paragraph, the requestor may not file such request 
     over protest under paragraph (5)(A)(iii).
       ``(7) Packaging.--An administrative order issued under 
     paragraph (2), (4)(A), or (5) may include requirements for 
     the packaging of a drug to encourage use in accordance with 
     labeling. Such requirements may include unit dose packaging, 
     requirements for products intended for use by children, 
     requirements to reduce risk of harm from unsupervised 
     ingestion, and other appropriate requirements. This paragraph 
     does not authorize the Food and Drug Administration to 
     require standards or testing procedures as described in part 
     1700 of title 16, Code of Federal Regulations.
       ``(8) Final and tentative final monographs for category i 
     drugs deemed final administrative orders.--
       ``(A) In general.--A final monograph or tentative final 
     monograph described in subparagraph (B) shall be deemed to be 
     a final administrative order under this subsection and may be 
     amended, revoked, or otherwise modified in accordance with 
     the procedures of this subsection.
       ``(B) Monographs described.--For purposes of subparagraph 
     (A), a final monograph or tentative final monograph is 
     described in this subparagraph if it--
       ``(i) establishes conditions of use for a drug described in 
     paragraph (1) or (2) of subsection (a); and
       ``(ii) represents the most recently promulgated version of 
     such conditions, including as modified, in whole or in part, 
     by any proposed or final rule.
       ``(C) Deemed orders include harmonizing technical 
     amendments.--The deemed establishment of a final 
     administrative order under subparagraph (A) shall be 
     construed to include any technical amendments to such order 
     as the Secretary determines necessary to ensure that such 
     order is appropriately harmonized, in terms of terminology or 
     cross-references, with the applicable provisions of this Act 
     (and regulations thereunder) and any other orders issued 
     under this section.
       ``(c) Procedure for Minor Changes.--
       ``(1) In general.--Minor changes in the dosage form of a 
     drug that is described in paragraph (1) or (2) of subsection 
     (a) or the subject of an order issued under subsection (b) 
     may be made by a requestor without the issuance of an order 
     under subsection (b) if--
       ``(A) the requestor maintains such information as is 
     necessary to demonstrate that the change--
       ``(i) will not affect the safety or effectiveness of the 
     drug; and
       ``(ii) will not materially affect the extent of absorption 
     or other exposure to the active ingredient in comparison to a 
     suitable reference product; and
       ``(B) the change is in conformity with the requirements of 
     an applicable administrative order issued by the Secretary 
     under paragraph (3).
       ``(2) Additional information.--
       ``(A) Access to records.--A sponsor shall submit records 
     requested by the Secretary relating to such a minor change 
     under section 704(a)(4), within 15 business days of receiving 
     such a request, or such longer period as the Secretary may 
     provide.
       ``(B) Insufficient information.--If the Secretary 
     determines that the information contained in such records is 
     not sufficient to demonstrate that the change does not affect 
     the safety or effectiveness of the drug or materially affect 
     the extent of absorption or other exposure to the active 
     ingredient, the Secretary--
       ``(i) may so inform the sponsor of the drug in writing; and
       ``(ii) provide the sponsor of the drug with a reasonable 
     opportunity to provide additional information.
       ``(C) Failure to submit sufficient information.--If the 
     sponsor fails to provide such additional information within 
     the prescribed time, or if the Secretary determines that such 
     additional information does not demonstrate that the change 
     does not affect the safety or effectiveness of the drug or 
     materially affect the extent of absorption or other exposure 
     to the active ingredient, the drug as modified is a new drug

[[Page H6231]]

     within the meaning of section 201(p) and shall be deemed to 
     be misbranded under section 502(ee).
       ``(3) Determining whether a change will affect safety or 
     effectiveness.--
       ``(A) In general.--The Secretary shall issue one or more 
     administrative orders specifying requirements for determining 
     whether a minor change made by a sponsor pursuant to this 
     subsection will affect the safety or effectiveness of a drug 
     or materially affect the extent of absorption or other 
     exposure to an active ingredient in the drug in comparison to 
     a suitable reference product, together with guidance for 
     applying those orders to specific dosage forms.
       ``(B) Standard practices.--The orders and guidance issued 
     by the Secretary under subparagraph (A) shall take into 
     account relevant public standards and standard practices for 
     evaluating the quality of drugs, and may take into account 
     the special needs of populations, including children.
       ``(d) Confidentiality of Information Submitted to the 
     Secretary.--
       ``(1) In general.--Subject to paragraph (2), any 
     information, including reports of testing conducted on the 
     drug or drugs involved, that is submitted by a requestor in 
     connection with proceedings on an order under this section 
     (including any minor change under subsection (c)) and is a 
     trade secret or confidential information subject to section 
     552(b)(4) of title 5, United States Code, or section 1905 of 
     title 18, United States Code, shall not be disclosed to the 
     public unless the requestor consents to that disclosure.
       ``(2) Public availability.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     the Secretary shall--
       ``(i) make any information submitted by a requestor in 
     support of a request under subsection (b)(5)(A) available to 
     the public not later than the date on which the proposed 
     order is issued; and
       ``(ii) make any information submitted by any other person 
     with respect to an order requested (or initiated by the 
     Secretary) under subsection (b), available to the public upon 
     such submission.
       ``(B) Limitations on public availability.--Information 
     described in subparagraph (A) shall not be made public if--
       ``(i) the information pertains to pharmaceutical quality 
     information, unless such information is necessary to 
     establish standards under which a drug is generally 
     recognized as safe and effective within the meaning of 
     section 201(p)(1);
       ``(ii) the information is submitted in a requestor-
     initiated request, but the requestor withdraws such request, 
     in accordance with withdrawal procedures established by the 
     Secretary, before the Secretary issues the proposed order;
       ``(iii) the Secretary requests and obtains the information 
     under subsection (c) and such information is not submitted in 
     relation to an order under subsection (b); or
       ``(iv) the information is of the type contained in raw 
     datasets.
       ``(e) Updates to Drug Listing Information.--A sponsor who 
     makes a change to a drug subject to this section shall submit 
     updated drug listing information for the drug in accordance 
     with section 510(j) within 30 calendar days of the date when 
     the drug is first commercially marketed, except that a 
     sponsor who was the order requestor with respect to an order 
     subject to subsection (b)(5)(C) (or a licensee, assignee, or 
     successor in interest of such requestor) shall submit updated 
     drug listing information on or before the date when the drug 
     is first commercially marketed.
       ``(f) Approvals Under Section 505.--The provisions of this 
     section shall not be construed to preclude a person from 
     seeking or maintaining the approval of a drug under sections 
     505(b)(1), 505(b)(2), and 505(j). A determination under this 
     section that a drug is not subject to section 503(b)(1), is 
     generally recognized as safe and effective within the meaning 
     of section 201(p)(1), and is not a new drug under section 
     201(p) shall constitute a finding that the drug is safe and 
     effective that may be relied upon for purposes of an 
     application under section 505(b)(2), so that the applicant 
     shall be required to submit for purposes of such application 
     only information needed to support any modification of the 
     drug that is not covered by such determination under this 
     section.
       ``(g) Public Availability of Administrative Orders.--The 
     Secretary shall establish, maintain, update (as determined 
     necessary by the Secretary but no less frequently than 
     annually), and make publicly available, with respect to 
     orders issued under this section--
       ``(1) a repository of each final order and interim final 
     order in effect, including the complete text of the order; 
     and
       ``(2) a listing of all orders proposed and under 
     development under subsection (b)(2), including--
       ``(A) a brief description of each such order; and
       ``(B) the Secretary's expectations, if resources permit, 
     for issuance of proposed orders over a three-year period.
       ``(h) Development Advice to Sponsors or Requestors.--The 
     Secretary shall establish procedures under which sponsors or 
     requestors may meet with appropriate officials of the Food 
     and Drug Administration to obtain advice on the studies and 
     other information necessary to support submissions under this 
     section and other matters relevant to the regulation of 
     nonprescription drugs and the development of new 
     nonprescription drugs under this section.
       ``(i) Participation of Multiple Sponsors or Requestors.--
     The Secretary shall establish procedures to facilitate 
     efficient participation by multiple sponsors or requestors in 
     proceedings under this section, including provision for joint 
     meetings with multiple sponsors or requestors or with 
     organizations nominated by sponsors or requestors to 
     represent their interests in a proceeding.
       ``(j) Electronic Format.--All submissions under this 
     section shall be in electronic format.
       ``(k) Effect on Existing Regulations Governing 
     Nonprescription Drugs.--
       ``(1) Regulations of general applicability to 
     nonprescription drugs.--Except as provided in this 
     subsection, nothing in this section supersedes regulations 
     establishing general requirements for nonprescription drugs, 
     including regulations of general applicability contained in 
     parts 201, 250, and 330 of title 21, Code of Federal 
     Regulations, or any successor regulations. The Secretary 
     shall establish or modify such regulations by means of 
     rulemaking in accordance with section 553 of title 5, United 
     States Code.
       ``(2) Regulations establishing requirements for specific 
     nonprescription drugs.--
       ``(A) The provisions of section 310.545 of title 21, Code 
     of Federal Regulations, as in effect on the day before the 
     date of the enactment of this section, shall be deemed to be 
     a final order under subsection (b).
       ``(B) Regulations in effect on the day before the date of 
     the enactment of this section, establishing requirements for 
     specific nonprescription drugs marketed pursuant to this 
     section (including such requirements in parts 201 and 250 of 
     title 21, Code of Federal Regulations), shall be deemed to be 
     final orders under subsection (b), only as they apply to 
     drugs--
       ``(i) subject to paragraph (1), (2), (3), or (4) of 
     subsection (a); or
       ``(ii) otherwise subject to an order under this section.
       ``(3) Withdrawal of regulations.--The Secretary shall 
     withdraw regulations establishing final monographs and the 
     procedures governing the over-the-counter drug review under 
     part 330 and other relevant parts of title 21, Code of 
     Federal Regulations (as in effect on the day before the date 
     of the enactment of this section), or make technical changes 
     to such regulations to ensure conformity with appropriate 
     terminology and cross references. Notwithstanding subchapter 
     II of chapter 5 of title 5, United States Code, any such 
     withdrawal or technical changes shall be made without public 
     notice and comment and shall be effective upon publication 
     through notice in the Federal Register (or upon such date as 
     specified in such notice).
       ``(l) Guidance.--The Secretary shall issue guidance that 
     specifies--
       ``(1) the procedures and principles for formal meetings 
     between the Secretary and sponsors or requestors for drugs 
     subject to this section;
       ``(2) the format and content of data submissions to the 
     Secretary under this section;
       ``(3) the format of electronic submissions to the Secretary 
     under this section;
       ``(4) consolidated proceedings and the procedures for such 
     proceedings where appropriate; and
       ``(5) for minor changes in drugs, recommendations on how to 
     comply with the requirements in orders issued under 
     subsection (c)(3).
       ``(m) Rule of Construction.--
       ``(1) In general.--This section shall not affect the 
     treatment or status of a nonprescription drug--
       ``(A) that is marketed without an application approved 
     under section 505 as of the date of the enactment of this 
     section;
       ``(B) that is not subject to an order issued under this 
     section; and
       ``(C) to which paragraphs (1), (2), (3), (4), or (5) of 
     subsection (a) do not apply.
       ``(2) Treatment of products previously found to be subject 
     to time and extent requirements.--
       ``(A) Notwithstanding subsection (a), a drug described in 
     subparagraph (B) may only be lawfully marketed, without an 
     application approved under section 505, pursuant to an order 
     issued under this section.
       ``(B) A drug described in this subparagraph is a drug 
     which, prior to the date of the enactment of this section, 
     the Secretary had determined in a proposed or final rule to 
     be ineligible for review under the OTC drug review (as such 
     phrase `OTC drug review' was used in section 330.14 of title 
     21, Code of Federal Regulations, as in effect on the day 
     before the date of the enactment of this section).
       ``(3) Preservation of authority.--
       ``(A) Nothing in paragraph (1) shall be construed to 
     preclude or limit the applicability of any other provision of 
     this Act.
       ``(B) Nothing in subsection (a) shall be construed to 
     prohibit the Secretary from issuing an order under this 
     section finding a drug to be not generally recognized as safe 
     and effective within the meaning of section 201(p)(1), as the 
     Secretary determines appropriate.
       ``(n) Investigational New Drugs.--A drug is not subject to 
     this section if an exemption for investigational use under 
     section 505(i) is in effect for such drug.
       ``(o) Inapplicability of Paperwork Reduction Act.--Chapter 
     35 of title 44, United States Code, shall not apply to 
     collections of information made under this section.
       ``(p) Inapplicability of Notice and Comment Rulemaking and 
     Other Requirements.--The requirements of subsection (b) shall 
     apply with respect to orders issued under this section 
     instead of the requirements of subchapter II of chapter 5 of 
     title 5, United States Code.
       ``(q) Definitions.--In this section:
       ``(1) The term `nonprescription drug' refers to a drug not 
     subject to the requirements of section 503(b)(1).
       ``(2) The term `sponsor' refers to any person marketing, 
     manufacturing, or processing a drug that--
       ``(A) is listed pursuant to section 510(j); and
       ``(B) is or will be subject to an administrative order of 
     the Food and Drug Administration.
       ``(3) The term `requestor' refers to any person or group of 
     persons marketing, manufacturing, processing, or developing a 
     drug.''.

[[Page H6232]]

  


     SEC. 102. MISBRANDING.

       Section 502 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 352) is amended by adding at the end the following:
       ``(ee) If it is a nonprescription drug that is subject to 
     section 505G, is not the subject of an application approved 
     under section 505, and does not comply with the requirements 
     under section 505G.
       ``(ff) If it is a drug and it was manufactured, prepared, 
     propagated, compounded, or processed in a facility for which 
     fees have not been paid as required by section 744O.''.

     SEC. 103. DRUGS EXCLUDED FROM THE OVER-THE-COUNTER DRUG 
                   REVIEW.

       (a) In General.--Nothing in this Act (or the amendments 
     made by this Act) shall apply to any nonprescription drug 
     which was excluded by the Food and Drug Administration from 
     the Over-the-Counter Drug Review in accordance with the 
     statement set out at page 9466 of volume 37 of the Federal 
     Register, published on May 11, 1972.
       (b) Rule of Construction.--Nothing in this section shall be 
     construed to preclude or limit the applicability of any other 
     provision of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.).

     SEC. 104. TREATMENT OF SUNSCREEN INNOVATION ACT.

       (a) Review of Nonprescription Sunscreen Active 
     Ingredients.--
       (1) Applicability of section 505g for pending 
     submissions.--
       (A) In general.--A sponsor of a nonprescription sunscreen 
     active ingredient or combination of nonprescription sunscreen 
     active ingredients that, as of the date of enactment of this 
     Act, is subject to a proposed sunscreen order under section 
     586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360fff-3) may elect, by means of giving written notification 
     to the Secretary of Health and Human Services within 180 
     calendar days of the enactment of this Act, to transition 
     into the review of such ingredient or combination of 
     ingredients pursuant to the process set out in section 505G 
     of the Federal Food, Drug, and Cosmetic Act, as added by 
     section 101 of this Act.
       (B) Election exercised.--Upon receipt by the Secretary of 
     Health and Human Services of a timely notification under 
     subparagraph (A)--
       (i) the proposed sunscreen order involved is deemed to be a 
     request for an order under subsection (b) of section 505G of 
     the Federal Food, Drug, and Cosmetic Act, as added by section 
     101 of this Act; and
       (ii) such order is deemed to have been accepted for filing 
     under subsection (b)(6)(A)(i) of such section 505G.
       (C) Election not exercised.--A sponsor of a nonprescription 
     sunscreen active ingredient or combination of nonprescription 
     sunscreen active ingredients described in subparagraph (A) 
     that does not elect for such ingredient or combination of 
     ingredients to be reviewed under section 505G of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 101 of this 
     Act, shall continue to have such ingredient or combination of 
     ingredients reviewed in accordance with section 586C of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3) and 
     may not subsequently elect to transition into the review of 
     such ingredient or combination of ingredients pursuant to the 
     process set out in section 505G of such Act, as added by 
     section 101 of this Act.
       (2) Definitions.--In this subsection, the terms 
     ``sponsor'', ``nonprescription'', ``sunscreen active 
     ingredient'', and ``proposed sunscreen order'' have the 
     meanings given to those terms in section 586 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360fff).
       (b) Amendments to Sunscreen Provisions.--
       (1) Final sunscreen orders.--Paragraph (3) of section 
     586C(e) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360fff-3(e)) is amended to read as follows:
       ``(3) Relationship to orders under section 505g.--A final 
     sunscreen order shall be deemed to be a final order under 
     section 505G.''.
       (2) Meetings.--Paragraph (7) of section 586C(b) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(b)) 
     is amended--
       (A) by striking ``A sponsor may request'' and inserting the 
     following:
       ``(A) In general.--A sponsor may request''; and
       (B) by adding at the end the following:
       ``(B) Confidential meetings.--A sponsor may request one or 
     more confidential meetings with respect to a proposed 
     sunscreen order, including a letter deemed to be a proposed 
     sunscreen order under paragraph (3), to discuss matters 
     involving confidential commercial information or trade 
     secrets. The Secretary shall convene a confidential meeting 
     with such sponsor in a reasonable time period. If a sponsor 
     requests more than one confidential meeting for the same 
     proposed sunscreen order, the Secretary may refuse to grant 
     an additional confidential meeting request if the Secretary 
     determines that such additional confidential meeting is not 
     reasonably necessary for the sponsor to advance its proposed 
     sunscreen order, or if the request for a confidential meeting 
     fails to include sufficient information upon which to base a 
     substantive discussion. The Secretary shall publish a post-
     meeting summary of each confidential meeting under this 
     subparagraph that does not disclose confidential commercial 
     information or trade secrets.''.
       (3) Sunset provision.--Subchapter I of chapter V of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et 
     seq.) is amended by adding at the end the following:

     ``SEC. 586H. SUNSET.

       ``This subchapter shall cease to be effective at the end of 
     fiscal year 2022.''.
       (4) Treatment of final sunscreen order.--The Federal Food, 
     Drug, and Cosmetic Act is amended by striking section 586E of 
     such Act (21 U.S.C. 360fff-5).
       (c) Treatment of Non-Sunscreen Time and Extent 
     Applications.--
       (1) In general.--Any application described in section 586F 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360fff-6) that was submitted to the Secretary of Health and 
     Human Services pursuant to section 330.14 of title 21, Code 
     of Federal Regulations, as such provisions were in effect 
     immediately prior to the date of enactment date of this Act, 
     shall be extinguished as of such date of enactment, subject 
     to paragraph (2).
       (2) Order request.--Nothing in paragraph (1) precludes the 
     submission of an order request under section 505G(b) of the 
     Federal Food, Drug, and Cosmetic Act, as added by section 101 
     of this Act, with respect to a drug that was the subject of 
     an application extinguished under paragraph (1).

     SEC. 105. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC 
                   INDICATION FOR CERTAIN OTC COUGH AND COLD 
                   DRUGS.

       (a) In General.--Subject to subsection (c), the Secretary 
     of Health and Human Services shall, beginning not later than 
     one year after the date of enactment of this Act, annually 
     submit to the Committee on Energy and Commerce of the House 
     of Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a letter describing the 
     progress of the Food and Drug Administration--
       (1) in evaluating the cough and cold monograph described in 
     subsection (b) with respect to children under age 6; and
       (2) as appropriate, revising such cough and cold monograph 
     to address such children through the order process under 
     section 505G(b) of the Federal Food, Drug, and Cosmetic Act, 
     as added by section 101 of this Act.
       (b) Cough and Cold Monograph Described.--The cough and cold 
     monograph described in this subsection consists of the 
     conditions under which nonprescription drugs containing 
     antitussive, expectorant, nasal decongestant, or 
     antihistamine active ingredients (or combinations thereof) 
     are generally recognized as safe and effective, as specified 
     in part 341 of title 21, Code of Federal Regulations (as in 
     effect immediately prior to the date of enactment of this 
     Act), and included in an order deemed to be established under 
     section 505G(b) of the Federal Food, Drug, and Cosmetic Act, 
     as added by section 101 of this Act.
       (c) Duration of Authority.--The requirement under 
     subsection (a) shall terminate as of the date of a letter 
     submitted by the Secretary of Health and Human Services 
     pursuant to such subsection in which the Secretary indicates 
     that the Food and Drug Administration has completed its 
     evaluation and revised, in a final order, as applicable, the 
     cough and cold monograph as described in subsection (a)(2).

                          TITLE II--USER FEES

     SEC. 201. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the ``Over-
     the-Counter Monograph User Fee Act of 2018''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made in this title will be dedicated to OTC 
     monograph drug activities, as set forth in the goals 
     identified for purposes of part 10 of subchapter C of chapter 
     VII of the Federal Food, Drug, and Cosmetic Act, in the 
     letters from the Secretary of Health and Human Services to 
     the Chairman of the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Chairman of the Committee 
     on Energy and Commerce of the House of Representatives, as 
     set forth in the Congressional Record.

     SEC. 202. FEES RELATING TO OVER-THE-COUNTER DRUGS.

       Subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379f et seq.) is amended by inserting 
     after part 9 the following:

           ``PART 10--FEES RELATING TO OVER-THE-COUNTER DRUGS

     ``SEC. 744N. DEFINITIONS.

       ``In this part:
       ``(1) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) one business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control, both 
     of the business entities.
       ``(2) The term `contract manufacturing organization 
     facility' means an OTC monograph drug facility where neither 
     the owner of such manufacturing facility nor any affiliate of 
     such owner or facility sells the OTC monograph drug produced 
     at such facility directly to wholesalers, retailers, or 
     consumers in the United States.
       ``(3) The term `costs of resources allocated for OTC 
     monograph drug activities' means the expenses in connection 
     with OTC monograph drug activities for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers, employees, and committees and costs related to 
     contracts with such contractors;
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources;
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies; and
       ``(D) collecting fees under section 744O and accounting for 
     resources allocated for OTC monograph drug activities.
       ``(4) The term `FDA establishment identifier' is the unique 
     number automatically generated by

[[Page H6233]]

     Food and Drug Administration's Field Accomplishments and 
     Compliance Tracking System (FACTS) (or any successor system).
       ``(5) The term `OTC monograph drug' means a nonprescription 
     drug without an approved new drug application which is 
     governed by the provisions of section 505G.
       ``(6) The term `OTC monograph drug activities' means 
     activities of the Secretary associated with OTC monograph 
     drugs and inspection of facilities associated with such 
     products, including the following activities:
       ``(A) The activities necessary for review and evaluation of 
     OTC monographs and OTC monograph order requests, including--
       ``(i) orders proposing or finalizing applicable conditions 
     of use for OTC monograph drugs;
       ``(ii) orders affecting status regarding general 
     recognition of safety and effectiveness of an OTC monograph 
     ingredient or combination of ingredients under specified 
     conditions of use;
       ``(iii) all OTC monograph drug development and review 
     activities, including intraagency collaboration;
       ``(iv) regulation and policy development activities related 
     to OTC monograph drugs;
       ``(v) development of product standards for products subject 
     to review and evaluation;
       ``(vi) meetings referred to in section 505G(i);
       ``(vii) review of labeling prior to issuance of orders 
     related to OTC monograph drugs or conditions of use; and
       ``(viii) regulatory science activities related to OTC 
     monograph drugs.
       ``(B) Inspections related to OTC monograph drugs.
       ``(C) Monitoring of clinical and other research conducted 
     in connection with OTC monograph drugs.
       ``(D) Safety activities with respect to OTC monograph 
     drugs, including--
       ``(i) collecting, developing, and reviewing safety 
     information on OTC monograph drugs, including adverse event 
     reports;
       ``(ii) developing and using improved adverse event data-
     collection systems, including information technology systems; 
     and
       ``(iii) developing and using improved analytical tools to 
     assess potential safety risks, including access to external 
     databases.
       ``(E) Other activities necessary for implementation of 
     section 505G.
       ``(7) The term `OTC monograph order request' means a 
     request for an order submitted under section 505G(b)(5).
       ``(8) The term `Tier 1 OTC monograph order request' means 
     any OTC monograph order request not determined to be a Tier 2 
     OTC monograph order request.
       ``(9)(A) The term `Tier 2 OTC monograph order request' 
     means, subject to subparagraph (B), an OTC monograph order 
     request for--
       ``(i) the reordering of existing information in the drug 
     facts label of an OTC monograph drug;
       ``(ii) the addition of information to the other information 
     section of the drug facts label of an OTC monograph drug, as 
     limited by section 201.66(c)(7) of title 21, Code of Federal 
     Regulations (or any successor regulations);
       ``(iii) modification to the directions for use section of 
     the drug facts label of an OTC monograph drug, if such 
     changes conform to changes made pursuant to section 
     505G(c)(3)(A);
       ``(iv) the standardization of the concentration or dose of 
     a specific finalized ingredient within a particular finalized 
     monograph;
       ``(v) a change to ingredient nomenclature to align with 
     nomenclature of a standards-setting organization; or
       ``(vi) addition of an interchangeable term in accordance 
     with section 330.1 of title 21, Code of Federal Regulations 
     (or any successor regulations).
       ``(B) The Secretary may, based on program implementation 
     experience or other factors found appropriate by the 
     Secretary, characterize any OTC monograph order request as a 
     Tier 2 OTC monograph order request (including 
     recharacterizing a request from Tier 1 to Tier 2) and publish 
     such determination in a proposed order issued pursuant to 
     section 505G.
       ``(10)(A) The term `OTC monograph drug facility' means a 
     foreign or domestic business or other entity that--
       ``(i) is--
       ``(I) under one management, either direct or indirect; and
       ``(II) at one geographic location or address engaged in 
     manufacturing or processing the finished dosage form of an 
     OTC monograph drug;
       ``(ii) includes a finished dosage form manufacturer 
     facility in a contractual relationship with the sponsor of 
     one or more OTC monograph drugs to manufacture or process 
     such drugs; and
       ``(iii) does not include a business or other entity whose 
     only manufacturing or processing activities are one or more 
     of the following: production of clinical research supplies, 
     or testing.
       ``(B) For purposes of subparagraph (A)(i)(II), separate 
     buildings or locations within close proximity are considered 
     to be at one geographic location or address if the activities 
     conducted in such buildings or locations are--
       ``(i) closely related to the same business enterprise;
       ``(ii) under the supervision of the same local management; 
     and
       ``(iii) under a single FDA establishment identifier and 
     capable of being inspected by the Food and Drug 
     Administration during a single inspection.
       ``(C) If a business or other entity would meet criteria 
     specified in subparagraph (A), but for being under multiple 
     management, the business or other entity is deemed to 
     constitute multiple facilities, one per management entity, 
     for purposes of this paragraph.
       ``(11) The term `OTC monograph drug meeting' means any 
     meeting regarding the content of a proposed OTC monograph 
     order request.
       ``(12) The term `person' includes an affiliate of a person.
       ``(13) The terms `requestor' and `sponsor' have the 
     meanings given such terms in section 505G.

     ``SEC. 744O. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.

       ``(a) Types of Fees.--Beginning with fiscal year 2019, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) Facility fee.--
       ``(A) In general.--Each person that owns a facility 
     identified as an OTC monograph drug facility on December 31 
     of the fiscal year or at any time during the preceding 12-
     month period shall be assessed an annual fee for each such 
     facility as determined under subsection (c).
       ``(B) Exceptions.--
       ``(i) A fee shall not be assessed under subparagraph (A) if 
     the identified OTC monograph drug facility has ceased all 
     activities related to OTC monograph drugs prior to the date 
     specified in subparagraph (D)(ii) and has updated its 
     registration to reflect such change under the requirements 
     for drug establishment registration set forth in section 510.
       ``(ii) The amount of the fee for a contract manufacturing 
     organization facility shall be equal to \2/3\ the amount of 
     the fee for an OTC monograph drug facility that is not a 
     contract manufacturing organization facility.
       ``(C) Amount.--The amount of fees established under 
     subparagraph (A) shall be established under subsection (c).
       ``(D) Due date.--
       ``(i) For first program year.--For fiscal year 2019, the 
     facility fees required under subparagraph (A) shall be due 45 
     calendar days after publication of the Federal Register 
     notice provided for under subsection (c)(4)(A).
       ``(ii) Subsequent fiscal years.--For each fiscal year after 
     fiscal year 2019, the facility fees required under 
     subparagraph (A) shall be due on the later of--

       ``(I) the first business day of June of such year; or
       ``(II) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees under this section for such year.

       ``(2) OTC monograph order request fee.--
       ``(A) In general.--Each person that submits an OTC 
     monograph order request shall be subject to a fee for an OTC 
     monograph order request. The amount of such fee shall be--
       ``(i) for a Tier 1 OTC monograph order request, $500,000, 
     adjusted for inflation for the fiscal year (as determined 
     under subsection (c)(1)(B)); and
       ``(ii) for a Tier 2 OTC monograph order request, $100,000 
     adjusted for inflation for the fiscal year (as determined 
     under subsection (c)(1)(B)).
       ``(B) Due date.--The OTC monograph order request fees 
     required under subparagraph (A) shall be due on the date of 
     submission of the OTC monograph order request.
       ``(C) Exception for certain safety changes.--A person who 
     is named as the requestor in an OTC monograph order shall not 
     be subject to a fee under subparagraph (A) if the Secretary 
     finds that the OTC monograph order request seeks to change 
     the drug facts labeling of an OTC monograph drug in a way 
     that would add to or strengthen--
       ``(i) a contraindication, warning, or precaution;
       ``(ii) a statement about risk associated with misuse or 
     abuse; or
       ``(iii) an instruction about dosage and administration that 
     is intended to increase the safe use of the OTC monograph 
     drug.
       ``(D) Refund of fee if order request is recategorized as a 
     tier 2 otc monograph order request.--If the Secretary 
     determines that an OTC monograph request initially 
     characterized as Tier 1 shall be re-characterized as a Tier 2 
     OTC monograph order request, and the requestor has paid a 
     Tier 1 fee in accordance with subparagraph (A)(i), the 
     Secretary shall refund the requestor the difference between 
     the Tier 1 and Tier 2 fees determined under subparagraphs 
     (A)(i) and (A)(ii), respectively.
       ``(E) Refund of fee if order request refused for filing or 
     withdrawn before filing.--The Secretary shall refund 75 
     percent of the fee paid under subparagraph (B) for any order 
     request which is refused for filing or was withdrawn before 
     being accepted or refused for filing.
       ``(F) Fees for order requests previously refused for filing 
     or withdrawn before filing.--An OTC monograph order request 
     that was submitted but was refused for filing, or was 
     withdrawn before being accepted or refused for filing, shall 
     be subject to the full fee under subparagraph (A) upon being 
     resubmitted or filed over protest.
       ``(G) Refund of fee if order request withdrawn.--If an 
     order request is withdrawn after the order request was filed, 
     the Secretary may refund the fee or a portion of the fee if 
     no substantial work was performed on the order request after 
     the application was filed. The Secretary shall have the sole 
     discretion to refund a fee or a portion of the fee under this 
     subparagraph. A determination by the Secretary concerning a 
     refund under this subparagraph shall not be reviewable.
       ``(3) Refunds.--
       ``(A) In general.--Other than refunds provided in 
     subparagraphs (D) through (G) of paragraph (2), the Secretary 
     shall not refund any fee paid under paragraph (1) except as 
     provided in subparagraph (B).
       ``(B) Disputes concerning fees.--To qualify for the return 
     of a fee claimed to have been paid in error under paragraph 
     (1) or (2), a person shall submit to the Secretary a written 
     request justifying such return within 180 calendar days after 
     such fee was paid.
       ``(4) Notice.--Within the timeframe specified in subsection 
     (c), the Secretary shall publish in the Federal Register the 
     amount of the fees under paragraph (1) for such fiscal year.

[[Page H6234]]

       ``(b) Fee Revenue Amounts.--
       ``(1) Fiscal year 2019.--For fiscal year 2019, fees under 
     subsection (a)(1) shall be established to generate a total 
     facility fee revenue amount equal to the sum of--
       ``(A) the annual base revenue for fiscal year 2019 (as 
     determined under paragraph (3);
       ``(B) the dollar amount equal to the operating reserve 
     adjustment for the fiscal year, if applicable (as determined 
     under subsection (c)(2)); and
       ``(C) additional direct cost adjustments (as determined 
     under subsection (c)(3)).
       ``(2) Subsequent fiscal years.--For each of the fiscal 
     years 2020 through 2023, fees under subsection (a)(1) shall 
     be established to generate a total facility fee revenue 
     amount equal to the sum of--
       ``(A) the annual base revenue for the fiscal year (as 
     determined under paragraph (3));
       ``(B) the dollar amount equal to the inflation adjustment 
     for the fiscal year (as determined under subsection (c)(1));
       ``(C) the dollar amount equal to the operating reserve 
     adjustment for the fiscal year, if applicable (as determined 
     under subsection (c)(2));
       ``(D) additional direct cost adjustments (as determined 
     under subsection (c)(3)); and
       ``(E) additional dollar amounts for each fiscal year as 
     follows:
       ``(i) $7,000,000 for fiscal year 2020.
       ``(ii) $6,000,000 for fiscal year 2021.
       ``(iii) $7,000,000 for fiscal year 2022.
       ``(iv) $3,000,000 for fiscal year 2023.
       ``(3) Annual base revenue.--For purposes of paragraphs 
     (1)(A) and (2)(A), the dollar amount of the annual base 
     revenue for a fiscal year shall be--
       ``(A) for fiscal year 2019, $8,000,000; and
       ``(B) for fiscal years 2020 through 2023, the dollar amount 
     of the total revenue amount established under this subsection 
     for the previous fiscal year, not including any adjustments 
     made under subsection (c)(2) or (c)(3).
       ``(c) Adjustments; Annual Fee Setting.--
       ``(1) Inflation adjustment.--
       ``(A) In general.--For purposes of subsection (b)(2)(B), 
     the dollar amount of the inflation adjustment to the annual 
     base revenue for fiscal year 2020 and each subsequent fiscal 
     year shall be equal to the product of--
       ``(i) such annual base revenue for the fiscal year under 
     subsection (b)(2); and
       ``(ii) the inflation adjustment percentage under 
     subparagraph (C).
       ``(B) OTC monograph order request fees.--For purposes of 
     subsection (a)(2), the dollar amount of the inflation 
     adjustment to the fee for OTC monograph order requests for 
     fiscal year 2020 and each subsequent fiscal year shall be 
     equal to the product of--
       ``(i) the applicable fee under subsection (a)(2) for the 
     preceding fiscal year; and
       ``(ii) the inflation adjustment percentage under 
     subparagraph (C).
       ``(C) Inflation adjustment percentage.--The inflation 
     adjustment percentage under this subparagraph for a fiscal 
     year is equal to--
       ``(i) for each of fiscal years 2020 and 2021, the average 
     annual percent change that occurred in the Consumer Price 
     Index for urban consumers (Washington-Baltimore, DC-MD-VA-WV; 
     Not Seasonally Adjusted; All items; Annual Index) for the 
     first 3 years of the preceding 4 years of available data; and
       ``(ii) for each of fiscal years 2022 and 2023, the sum of--

       ``(I) the average annual percent change in the cost, per 
     full-time equivalent position of the Food and Drug 
     Administration, of all personnel compensation and benefits 
     paid with respect to such positions for the first 3 years of 
     the preceding 4 fiscal years, multiplied by the proportion of 
     personnel compensation and benefits costs to total costs of 
     OTC monograph drug activities for the first 3 years of the 
     preceding 4 fiscal years; and
       ``(II) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by the proportion of all costs 
     other than personnel compensation and benefits costs to total 
     costs of OTC monograph drug activities for the first 3 years 
     of the preceding 4 fiscal years.

       ``(2) Operating reserve adjustment.--
       ``(A) In general.--For fiscal year 2019 and subsequent 
     fiscal years, for purposes of subsections (b)(1)(B) and 
     (b)(2)(C), the Secretary may, in addition to adjustments 
     under paragraph (1), further increase the fee revenue and 
     fees if such an adjustment is necessary to provide operating 
     reserves of carryover user fees for OTC monograph drug 
     activities for not more than the number of weeks specified in 
     subparagraph (B).
       ``(B) Number of weeks.--The number of weeks specified in 
     this subparagraph is--
       ``(i) 3 weeks for fiscal year 2019;
       ``(ii) 7 weeks for fiscal year 2020;
       ``(iii) 10 weeks for fiscal year 2021;
       ``(iv) 10 weeks for fiscal year 2022; and
       ``(v) 10 weeks for fiscal year 2023.
       ``(C) Decrease.--If the Secretary has carryover balances 
     for such process in excess of 10 weeks of the operating 
     reserves referred to in subparagraph (A), the Secretary shall 
     decrease the fee revenue and fees referred to in such 
     subparagraph to provide for not more than 10 weeks of such 
     operating reserves.
       ``(D) Rationale for adjustment.--If an adjustment under 
     this paragraph is made, the rationale for the amount of the 
     increase or decrease (as applicable) in fee revenue and fees 
     shall be contained in the annual Federal Register notice 
     under paragraph (4) establishing fee revenue and fees for the 
     fiscal year involved.
       ``(3) Additional direct cost adjustment.--The Secretary 
     shall, in addition to adjustments under paragraphs (1) and 
     (2), further increase the fee revenue and fees for purposes 
     of subsection (b)(2)(D) by an amount equal to--
       ``(A) $14,000,000 for fiscal year 2019;
       ``(B) $7,000,000 for fiscal year 2020;
       ``(C) $4,000,000 for fiscal year 2021;
       ``(D) $3,000,000 for fiscal year 2022; and
       ``(E) $3,000,000 for fiscal year 2023.
       ``(4) Annual fee setting.--
       ``(A) Fiscal year 2019.--The Secretary shall, not later 
     than January 31, 2019--
       ``(i) establish OTC monograph drug facility fees for fiscal 
     year 2019 under subsection (a), based on the revenue amount 
     for such year under subsection (b) and the adjustments 
     provided under this subsection; and
       ``(ii) publish fee revenue, facility fees, and OTC 
     monograph order requests in the Federal Register.
       ``(B) Subsequent fiscal years.--The Secretary shall, not 
     later than January 31 of each fiscal year that begins after 
     September 30, 2019, establish for each such fiscal year, 
     based on the revenue amounts under subsection (b) and the 
     adjustments provided under this subsection--
       ``(i) OTC monograph drug facility fees under subsection 
     (a)(1);
       ``(ii) OTC monograph order request fees under subsection 
     (a)(2); and
       ``(iii) publish such fee revenue amounts, facility fees, 
     and OTC monograph order request fees in the Federal Register.
       ``(d) Identification of Facilities.--Each person that owns 
     an OTC monograph drug facility shall submit to the Secretary 
     the information required under this subsection each year. 
     Such information shall, for each fiscal year--
       ``(1) be submitted as part of the requirements for drug 
     establishment registration set forth in section 510; and
       ``(2) include for each such facility, at a minimum, 
     identification of the facility's business operation as that 
     of an OTC monograph drug facility.
       ``(e) Effect of Failure To Pay Fees.--
       ``(1) OTC monograph drug facility fee.--
       ``(A) In general.--Failure to pay the fee under subsection 
     (a)(1) within 20 calendar days of the due date as specified 
     in subparagraph (D) of such subsection shall result in the 
     following:
       ``(i) The Secretary shall place the facility on a publicly 
     available arrears list.
       ``(ii) All OTC monograph drugs manufactured in such a 
     facility or containing an ingredient manufactured in such a 
     facility shall be deemed misbranded under section 502(a).
       ``(B) Application of penalties.--The penalties under this 
     paragraph shall apply until the fee established by subsection 
     (a)(1) is paid.
       ``(2) Order requests.--An OTC monograph order request 
     submitted by a person subject to fees under subsection (a) 
     shall be considered incomplete and shall not be accepted for 
     filing by the Secretary until all fees owed by such person 
     under this section have been paid.
       ``(3) Meetings.--A person subject to fees under this 
     section shall be considered ineligible for OTC monograph drug 
     meetings until all such fees owed by such person have been 
     paid.
       ``(f) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts. Such fees are authorized to remain 
     available until expended. Such sums as may be necessary may 
     be transferred from the Food and Drug Administration salaries 
     and expenses appropriation account without fiscal year 
     limitation to such appropriation account for salaries and 
     expenses with such fiscal year limitation. The sums 
     transferred shall be available solely for OTC monograph drug 
     activities.
       ``(2) Collections and appropriation acts.--
       ``(A) In general.--Subject to subparagraph (C), the fees 
     authorized by this section shall be collected and available 
     in each fiscal year in an amount not to exceed the amount 
     specified in appropriation Acts, or otherwise made available 
     for obligation, for such fiscal year.
       ``(B) Use of fees and limitation.--The fees authorized by 
     this section shall be available to defray increases in the 
     costs of the resources allocated for OTC monograph drug 
     activities (including increases in such costs for an 
     additional number of full-time equivalent positions in the 
     Department of Health and Human Services to be engaged in such 
     activities), only if the Secretary allocates for such purpose 
     an amount for such fiscal year (excluding amounts from fees 
     collected under this section) no less than $12,000,000, 
     multiplied by the adjustment factor applicable to the fiscal 
     year involved under subsection (c)(1).
       ``(C) Compliance.--The Secretary shall be considered to 
     have met the requirements of subparagraph (B) in any fiscal 
     year if the costs funded by appropriations and allocated for 
     OTC monograph drug activities are not more than 15 percent 
     below the level specified in such subparagraph.
       ``(D) Provision for early payments in subsequent years.--
     Payment of fees authorized under this section for a fiscal 
     year (after fiscal year 2019), prior to the due date for such 
     fees, may be accepted by the Secretary in accordance with 
     authority provided in advance in a prior year appropriations 
     Act.
       ``(3) Authorization of appropriations.--For each of the 
     fiscal years 2019 through 2023, there is authorized to be 
     appropriated for fees under this section an amount equal to 
     the total amount of fees assessed for such fiscal year under 
     this section.
       ``(g) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 calendar days after it is due, such 
     fee shall be treated as a claim of the United States 
     Government subject to subchapter II of chapter 37 of title 
     31, United States Code.
       ``(h) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of

[[Page H6235]]

     Health and Human Services, for officers, employers, and 
     advisory committees not engaged in OTC monograph drug 
     activities, be reduced to offset the number of officers, 
     employees, and advisory committees so engaged.

     ``SEC. 744P. REAUTHORIZATION; REPORTING REQUIREMENTS.

       ``(a) Performance Report.--Beginning with fiscal year 2019, 
     and not later than 120 calendar days after the end of each 
     fiscal year thereafter for which fees are collected under 
     this part, the Secretary shall prepare and submit to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report concerning the 
     progress of the Food and Drug Administration in achieving the 
     goals identified in the letters described in section 201(b) 
     of the Over-the-Counter Monograph Safety, Innovation, and 
     Reform Act of 2018 during such fiscal year and the future 
     plans of the Food and Drug Administration for meeting such 
     goals.
       ``(b) Fiscal Report.--Not later than 120 calendar days 
     after the end of fiscal year 2019 and each subsequent fiscal 
     year for which fees are collected under this part, the 
     Secretary shall prepare and submit to the Committee on Energy 
     and Commerce of the House of Representatives and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate a report on the implementation of the authority for 
     such fees during such fiscal year and the use, by the Food 
     and Drug Administration, of the fees collected for such 
     fiscal year.
       ``(c) Public Availability.--The Secretary shall make the 
     reports required under subsections (a) and (b) available to 
     the public on the Internet website of the Food and Drug 
     Administration.
       ``(d) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to the Congress with respect to the goals described 
     in subsection (a), and plans for meeting the goals, for OTC 
     monograph drug activities for the first 5 fiscal years after 
     fiscal year 2023, and for the reauthorization of this part 
     for such fiscal years, the Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the regulated industry.
       ``(2) Public review of recommendations.--After negotiations 
     with the regulated industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 calendar days for the 
     public to provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(3) Transmittal of recommendations.--Not later than 
     January 15, 2023, the Secretary shall transmit to the 
     Congress the revised recommendations under paragraph (2), a 
     summary of the views and comments received under such 
     paragraph, and any changes made to the recommendations in 
     response to such views and comments.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Ohio (Mr. Latta) and the gentleman from Texas (Mr. Gene Green) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Ohio.


                             General Leave

  Mr. LATTA. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous material in the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Ohio?
  There was no objection.
  Mr. LATTA. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in support of H.R. 5333, the Over-the-
Counter Monograph Safety, Innovation, and Reform Act.
  Over-the-counter medications are widely used to treat common ailments 
such as colds, headaches, and seasonal allergies. In fact, more than 
240 million Americans use OTC products every year and trust these 
affordable remedies to get well and stay well.
  Despite the success and high utilization of these medicines, the Food 
and Drug Administration's regulatory framework for oversight of OTC 
products, also called the monograph system, is outdated and incomplete. 
The system was created more than 45 years ago, yet movement on 
unfinished items has ground to a halt due to the cumbersome notice and 
comment rulemaking process. I will give an example that was pointed out 
in committee that the FDA brought out.
  The FDA advanced notice proposed rulemaking for this one started on 
December 4, 1979. Through a process of 20 different procedures they 
went through, they got to November 19, 1997, almost 18 years later, and 
what do they do? They reopen the administrative records to consider new 
data. It is taking too long. That is what this bill would remedy.
  The lack of modernization makes it impossible for manufacturers to 
address safety concerns and offers little incentive to develop new 
products.
  H.R. 5333, which I introduced with the Health Subcommittee chairman, 
the gentleman from Texas (Mr. Burgess); the Health Subcommittee vice 
chairman, the gentleman from Kentucky (Mr. Guthrie); the Health 
Subcommittee ranking member, the gentleman from Texas (Mr. Gene Green), 
the gentlewoman from Colorado (Ms. DeGette); and the gentlewoman from 
Michigan (Mrs. Dingell) would provide meaningful and long overdue 
reform to FDA's monograph system.
  The necessary reforms would create a more flexible framework that 
accounts for advances in science, permits timely updates to safety 
information and label changes, and creates a workable process for 
completing unfinished monographs.
  By updating the current burdensome process, Congress would also 
create a pathway to market for new and innovative products that greatly 
benefit our constituents and reduce strain on our healthcare system.
  Safe, reliable, and affordable OTC drugs allow consumers to treat 
common ailments at home, usually without visiting a healthcare 
provider, saving the healthcare system $102 billion annually.
  Our bill would improve regulatory certainty for manufacturers and, 
over time, we would see additional investment in research and 
development, leading to new, innovative OTC medicines that will 
continue to save Americans and our healthcare system money.
  I thank my colleagues, FDA, and stakeholders for working so closely 
with me over the last 2 years to ensure that this modernization effort 
appropriately addresses and resolves this complex issue.
  I strongly urge my colleagues to support passage of H.R. 5333 to 
modernize the broken monograph system, strengthen consumer protection, 
spur innovation, and increase consumer choice.
  Mr. Speaker, I reserve the balance of my time.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker, I rise today in support of H.R. 5333, the Over-the-
Counter Monograph, Safety, Innovation and Reform Act.
  I am a proud original cosponsor of this legislation that will 
strengthen the Food and Drug Administration's ability to oversee the 
over-the-counter drug market and establish a user fee program for this 
market for the first time.
  H.R. 5333 is legislation that enjoys bipartisan support and would 
reform the current monograph system that is relied upon by industry to 
legally market over-the-counter drugs in response to concerns raised by 
both the FDA and the industry that the current system is outdated and 
burdensome.
  Under current law, the safety and effectiveness of over-the-counter 
drugs is established through conformance with a monograph. Monographs 
serve as a type of rule book outlining the conditions of use for a 
particular drug ingredient, including the dosage form, patient 
population, labeling and warnings, and other requirements. This rule 
book is established currently through a three-phase rulemaking process 
and is very resource and time intensive.
  This process has made it difficult for the FDA to finalize, revise, 
or update monographs to reflect innovations, changes in science, or to 
respond to safety issues.
  We also have heard from the industry that the current process 
inadvertently discourages innovation, as it is not nimble enough to 
respond to evolving science and technology.
  The legislation we are considering today would address these concerns 
by transitioning the monograph system from rulemaking to administrative 
order, create a procedure for the FDA to respond to the needs for 
safety label changes, and establish an innovation pathway.

[[Page H6236]]

  These reforms can only be successful if it is also accompanied by 
stable and reliable funding that more appropriately represents the 
growth and science of the over-the-counter industry.
  Today, the over-the-counter monograph program oversees more than 
100,000 products with a staff of about 30 people and a budget of just 
over $8 million. The user fees provided in this bill would help the FDA 
transition the monograph program from rulemaking to administrative 
order, provide for additional staff capacity, and enable the FDA to 
respond to innovation and safety changes in the current market.

  I want to thank my colleague from Ohio, Congressman Bob Latta, for 
introducing this legislation and for working with me and other members 
of our committee. I would like to thank the original cosponsors of the 
bill, Representative Diana DeGette, Representative Debbie Dingell, 
Chairman Mike Burgess, and Representative Brett Guthrie for their 
dedication and hard work on this important issue.
  I ask all my colleagues to join me in supporting the Over-the-Counter 
Monograph Safety, Innovation, and Reform Act.
  Mr. Speaker, I reserve the balance of my time.
  Mr. LATTA. Mr. Speaker, I yield such time as he may consume to the 
gentleman from Texas (Mr. Burgess), the chairman of the Health 
Subcommittee on Energy and Commerce.
  Mr. BURGESS. Mr. Speaker, I rise today to speak in support of this 
important, bipartisan bill to modernize the regulation of over-the-
counter medicines.
  An over-the-counter product is one that the Food and Drug 
Administration has found to be safe and effective for direct consumer 
use. To date, consumers have access to over 300,000 of these 
nonprescription items. We are all familiar with these products, from 
cough and cold medicines to antiperspirants, antacids, and sunscreens. 
Our pharmacy aisles and medicine cabinets are filled with over-the-
counter products that American consumers rely on each and every day.
  These products do not need premarket approval but are required to be 
consistent with monographs established by the Food and Drug 
Administration. Making a simple change to existing monographs requires 
a time-consuming and resource-intensive rulemaking process that can, in 
fact, take years to effectuate even if the change is to enhance the 
safety of a product. This creates undue delay in potential benefits 
seen by consumers and is an inefficient use of public resources.

                              {time}  1815

  Fortunately, the Food and Drug Administration, patient and consumer 
groups, and the regulated industry all agreed that reform is necessary 
and have spent the past several years engaged in discussions about 
modernization of the over-the-counter regulation. Congress worked with 
these groups to turn these discussions into legislation that we are 
considering this afternoon.
  This bill would make the over-the-counter regulatory framework more 
science based and responsive to public health concerns. It would 
encourage the development of more innovative products and would provide 
resources to the Food and Drug Administration to bolster the agency's 
ability to review over-the-counter applications and regulate this 
sector in a consistent manner.
  Quite simply, it is a meaningful bill for each American.
  I want to thank our Energy and Commerce Committee Members, 
Representatives Latta from Ohio, Diana DeGette from Colorado, Brett 
Guthrie from Kentucky, Debbie Dingell from Michigan, as well as Ranking 
Member Green, my colleague from Texas, for their leadership in this 
legislation.
  I also want to recognize the hard work and the dedication of 
committee staff on this legislation, particularly Warren Burke and 
Michelle Vanek of the Office of Legislative Counsel; Danielle Steele, 
with our majority staff; and Kim Trzeciak, with the committee's 
Democratic staff. I urge my colleagues to support the passage of this 
bill.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield 3 minutes to the 
gentlewoman from Michigan (Mrs. Dingell).


 =========================== NOTE =========================== 

  
  July 16, 2018, on page H6236, the following appeared: Mr. GREEN 
of Texas. Mr. Speaker, I yield 3 minutes to the gentlewoman from 
Michigan (Mrs. Dingell).
  
  The online version has been corrected to read: Mr. GENE GREEN of 
Texas. Mr. Speaker, I yield 3 minutes to the gentlewoman from 
Michigan (Mrs. Dingell).


 ========================= END NOTE ========================= 

  Mrs. DINGELL. Mr. Speaker, I thank the gentleman from Texas for 
yielding to me.
  Mr. Speaker, I rise in support of H.R. 5333, the Over-the-Counter 
Monograph Safety, Innovation, and Reform Act of 2018, and I want to 
thank Chairman Walden and Ranking Member Pallone for bringing this 
important bill to the floor.
  The monograph system for regulating over-the-counter drugs is broken, 
plain and simple. Mr. Speaker, 60 percent of all medicines sold in the 
United States are over the counter, yet the FDA only has 18 full-time 
employees overseeing the market. It doesn't work for patients; it 
doesn't work for companies; and it doesn't work for the FDA.
  Companies cannot bring new, innovative products to market and the FDA 
cannot act quickly when they are faced with a safety risk. This is not 
reflective of how our healthcare system should be run, and it is 
putting patients at risk.
  Our legislation helps bring the agency into the 21st century by 
creating a user fee program at FDA for OTC drugs and by making it 
easier to bring a new, innovative product to the market. From past 
experience, we know that user fee programs have been very successful at 
FDA, and this bill extends that successful model to the OTC space.
  Today, the FDA has to go through the cumbersome rulemaking process to 
update a monograph, which is problematic for many different reasons. 
Not only does it make it harder for innovative products to come to 
market, but it also makes it nearly impossible for the FDA to amend 
existing monographs if they see safety concerns in certain products.
  We need to make sure FDA has the ability to act quickly if they see 
unsafe products in the market, and our legislation makes it easier for 
the agency to do so. This is why the bill has the support of industry 
groups and consumer groups.
  Mr. Speaker, I know that there has been much discussion about the 
exclusivity provisions of this legislation. It has been debated in 
committee, and we compromised with 18 months of exclusivity. I will be 
the first to admit it is not perfect, but, on balance, the public 
health benefits of this bill outweigh any concerns about exclusivity.
  Americans deserve to have the most innovative products on the market 
available to them, while ensuring the FDA has the resources they need 
to protect public health. I am proud to say that this legislation 
accomplishes both these goals.
  I, too, want to thank my colleagues, Bob Latta, Diana DeGette, Brett 
Guthrie, Gene Green, Dr. Burgess, Chairman Walden, and Ranking Member 
Pallone for all their hard work on this legislation. Their staffs 
worked tirelessly as well on this, and I want to thank all of them for 
their efforts.
  Passage of this bill represents another step towards getting our 
legislation signed into law this year. I urge my colleagues to support 
H.R. 5333.
  Mr. LATTA. Mr. Speaker, I yield 2 minutes to the gentleman from 
Georgia (Mr. Carter), my friend and colleague.
  Mr. CARTER of Georgia. Mr. Speaker, I would like to thank my 
colleagues for introducing this critical legislation.
  As it stands, the OTC monograph system is slow and outdated, leading 
to new changes being stuck in the pipeline for years with no light at 
the end of the tunnel. As a pharmacist, I know how important it is to 
my patients that they have access to new uses and applications.
  Regardless of the application needed under a monograph, today's 
legislation puts in place changes that will help those who I have spent 
my life assisting: the patient.
  This legislation establishes a mechanism for safety label changes, 
giving these new efforts an outlet through which to get changes for the 
public quickly available and on shelves.
  This critical legislation will shorten market exclusivity by 6 months 
for certain new over-the-counter products approved without a new drug 
application and will also bolster the staffing capability at the FDA 
overseeing the OTC drug industry.
  Over-the-counter drug innovation has faced challenges for years, and, 
with

[[Page H6237]]

this legislation, we finally have an opportunity to open up these 
channels that will help everyone.

  I voted for this legislation through the subcommittee and through 
full committee and am proud to offer my full support to pass this 
legislation.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield 3 minutes to the 
gentlewoman from Colorado (Ms. DeGette), my colleague and a member of 
our committee.


 =========================== NOTE =========================== 

  
  July 16, 2018, on page H6237, the following appeared: Mr. GREEN 
of Texas. Mr. Speaker, I yield 3 minutes to the gentlewoman from 
Colorado (Ms. Degette), my colleague and a member of our 
committee.
  
  The online version has been corrected to read: Mr. GENE GREEN of 
Texas. Mr. Speaker, I yield 3 minutes to the gentlewoman from 
Colorado (Ms. Degette), my colleague and a member of our 
committee.


 ========================= END NOTE ========================= 

  Ms. DeGETTE. Mr. Speaker, today we have an opportunity to make long-
overdue reforms to the way that the FDA reviews over-the-counter 
medicines. These medicines play a critical role in treating Americans' 
ailments and in helping us stay healthy. In fact, almost 7 in 10 
parents report giving their kids OTC medicine to help treat sudden 
medical symptoms. Similarly, 81 percent of adults use these drugs as a 
first response to treat a minor ailment.
  Think about it. Despite the widespread use of over-the-counter 
medicines, the FDA is currently forced to use a cumbersome and 
laborious monograph pathway to approve them. This antiquated, 40-year-
old OTC review system has not kept pace with new medical advances and 
the rapid expansion of this market, which now comprises over 300,000 
drugs. As a result, the current monograph review system fails to 
respond to the OTC safety issues in a timely and effective way, which 
can pose serious healthcare risks for children and families.
  Between 2004 and 2005, for example, the Centers for Disease Control 
and Prevention reported 1,500 cases of children under the age of 2 
visiting emergency rooms due to serious side effects or overdoses 
associated with over-the-counter cough and cold products.
  Since the CDC made this startling finding, the FDA has been trying to 
revise the cough and cold monograph system to warn parents about the 
risks that these common drugs can pose to children, but the FDA can't 
do it because they have been hamstrung due to the burdensome process it 
must undergo to revise these monographs.
  The Over-the-Counter Monograph Safety, Innovation, and Reform Act 
would streamline the FDA's review of over-the-counter drugs and provide 
it with new tools to protect children and warn parents about 
potentially dangerous OTC drugs.
  I want to add my thanks to the bipartisan team that passed this bill, 
Representatives Latta, Burgess, Green, Guthrie, and Dingell for all 
working together with me on this important legislation, and, in 
addition, Ranking Member Pallone, Chairman Walden, the FDA, and the 
many stakeholders that have worked closely with us throughout the 
process.
  Mr. Speaker, the bill is a rare triple win for regulators, consumers, 
and industry. I urge my colleagues' support.
  Mr. GENE GREEN of Texas. Mr. Speaker, I have no other speakers, and I 
yield back the balance of my time.


 =========================== NOTE =========================== 

  
  July 16, 2018, on page H6237, the following appeared: Mr. GREEN 
of Texas. Mr. Speaker, I have no other speakers, and I yield back 
the balance of my time.
  
  The online version has been corrected to read: Mr. GENE GREEN of 
Texas. Mr. Speaker, I have no other speakers, and I yield back the 
balance of my time.


 ========================= END NOTE ========================= 

  Mr. LATTA. Mr. Speaker, once again, I just want to thank all the 
members for all their hard work on this. Especially, I want to thank 
the gentleman from Oregon, the chairman of the full committee, for his 
work on this piece of legislation. Also, I want to thank the staff.
  Mr. Speaker, I urge passage of the bill.
  The SPEAKER pro tempore (Mr. Smith of Nebraska). The question is on 
the motion offered by the gentleman from Ohio (Mr. Latta) that the 
House suspend the rules and pass the bill, H.R. 5333, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________