Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

IC 116TH CONGRESS 1ST SESSION S. 2740 IN THE HOUSE OF REPRESENTATIVES DECEMBER 11, 2019 Referred to the Committee on Energy and Commerce AN ACT 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 ap- proved new drug application, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 2 S 2740 RFH SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 1 (a) SHORT TITLE.—This Act may be cited as the 2 ‘‘Over-the-Counter Monograph Safety, Innovation, and 3 Reform Act of 2019’’. 4 (b) TABLE OF CONTENTS.—The table of contents for 5 this Act is as follows: 6 Sec. 1. Short title; table of contents. TITLE I—OTC DRUG REVIEW Sec. 101. Regulation of certain nonprescription drugs that are marketed with- out an approved drug application. Sec. 102. Misbranding. Sec. 103. Drugs excluded from the over-the-counter drug review. Sec. 104. Treatment of Sunscreen Innovation Act. Sec. 105. Annual update to Congress on appropriate pediatric indication for certain OTC cough and cold drugs. Sec. 106. Technical corrections. TITLE II—USER FEES Sec. 201. Short title; finding. Sec. 202. Fees relating to over-the-counter drugs. TITLE I—OTC DRUG REVIEW 7 SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION 8 DRUGS THAT ARE MARKETED WITHOUT AN 9 APPROVED DRUG APPLICATION. 10 (a) IN GENERAL.—Chapter V of the Federal Food, 11 Drug, and Cosmetic Act is amended by inserting after sec- 12 tion 505F of such Act (21 U.S.C. 355g) the following: 13 ‘‘SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION 14 DRUGS THAT ARE MARKETED WITHOUT AN 15 APPROVED DRUG APPLICATION. 16 ‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITH- 17 OUT AN APPROVED APPLICATION.—Nonprescription 18 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 3 S 2740 RFH drugs marketed without an approved drug application 1 under section 505, as of the date of the enactment of this 2 section, shall be treated in accordance with this sub- 3 section. 4 ‘‘(1) DRUGS SUBJECT TO A FINAL MONOGRAPH; 5 CATEGORY I DRUGS SUBJECT TO A TENTATIVE 6 FINAL MONOGRAPH.—A drug is deemed to be gen- 7 erally recognized as safe and effective under section 8 201(p)(1), not a new drug under section 201(p), and 9 not subject to section 503(b)(1), if— 10 ‘‘(A) the drug is— 11 ‘‘(i) in conformity with the require- 12 ments for nonprescription use of a final 13 monograph issued under part 330 of title 14 21, Code of Federal Regulations (except as 15 provided in paragraph (2)), the general re- 16 quirements for nonprescription drugs, and 17 conditions or requirements under sub- 18 sections (b), (c), and (k); and 19 ‘‘(ii) except as permitted by an order 20 issued under subsection (b) or, in the case 21 of a minor change in the drug, in con- 22 formity with an order issued under sub- 23 section (c), in a dosage form that, imme- 24 diately prior to the date of the enactment 25 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 4 S 2740 RFH of this section, has been used to a material 1 extent and for a material time under sec- 2 tion 201(p)(2); or 3 ‘‘(B) the drug is— 4 ‘‘(i) classified in category I for safety 5 and effectiveness under a tentative final 6 monograph that is the most recently appli- 7 cable proposal or determination issued 8 under part 330 of title 21, Code of Federal 9 Regulations; 10 ‘‘(ii) in conformity with the proposed 11 requirements for nonprescription use of 12 such tentative final monograph, any appli- 13 cable subsequent determination by the Sec- 14 retary, the general requirements for non- 15 prescription drugs, and conditions or re- 16 quirements under subsections (b), (c), and 17 (k); and 18 ‘‘(iii) except as permitted by an order 19 issued under subsection (b) or, in the case 20 of a minor change in the drug, in con- 21 formity with an order issued under sub- 22 section (c), in a dosage form that, imme- 23 diately prior to the date of the enactment 24 of this section, has been used to a material 25 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 5 S 2740 RFH extent and for a material time under sec- 1 tion 201(p)(2). 2 ‘‘(2) TREATMENT OF SUNSCREEN DRUGS.— 3 With respect to sunscreen drugs subject to this sec- 4 tion, the applicable requirements in terms of con- 5 formity with a final monograph, for purposes of 6 paragraph (1)(A)(i), shall be the requirements speci- 7 fied in part 352 of title 21, Code of Federal Regula- 8 tions, as published on May 21, 1999, beginning on 9 page 27687 of volume 64 of the Federal Register, 10 except that the applicable requirements governing ef- 11 fectiveness and labeling shall be those specified in 12 section 201.327 of title 21, Code of Federal Regula- 13 tions. 14 ‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN- 15 TATIVE FINAL MONOGRAPH; CATEGORY I DRUGS 16 SUBJECT TO PROPOSED MONOGRAPH OR ADVANCE 17 NOTICE OF PROPOSED RULEMAKING.—A drug that 18 is not described in paragraph (1), (2), or (4) is not 19 required to be the subject of an application approved 20 under section 505, and is not subject to section 21 503(b)(1), if— 22 ‘‘(A) the drug is— 23 ‘‘(i) classified in category III for safe- 24 ty or effectiveness in the preamble of a 25 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 6 S 2740 RFH proposed rule establishing a tentative final 1 monograph that is the most recently appli- 2 cable proposal or determination for such 3 drug issued under part 330 of title 21, 4 Code of Federal Regulations; 5 ‘‘(ii) in conformity with— 6 ‘‘(I) the conditions of use, includ- 7 ing indication and dosage strength, if 8 any, described for such category III 9 drug in such preamble or in an appli- 10 cable subsequent proposed rule; 11 ‘‘(II) the proposed requirements 12 for drugs classified in such tentative 13 final monograph in category I in the 14 most recently proposed rule estab- 15 lishing requirements related to such 16 tentative final monograph and in any 17 final rule establishing requirements 18 that are applicable to the drug; and 19 ‘‘(III) the general requirements 20 for nonprescription drugs and condi- 21 tions or requirements under sub- 22 section (b) or (k); and 23 ‘‘(iii) in a dosage form that, imme- 24 diately prior to the date of the enactment 25 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 7 S 2740 RFH of this section, had been used to a material 1 extent and for a material time under sec- 2 tion 201(p)(2); or 3 ‘‘(B) the drug is— 4 ‘‘(i) classified in category I for safety 5 and effectiveness under a proposed mono- 6 graph or advance notice of proposed rule- 7 making that is the most recently applicable 8 proposal or determination for such drug 9 issued under part 330 of title 21, Code of 10 Federal Regulations; 11 ‘‘(ii) in conformity with the require- 12 ments for nonprescription use of such pro- 13 posed monograph or advance notice of pro- 14 posed rulemaking, any applicable subse- 15 quent determination by the Secretary, the 16 general requirements for nonprescription 17 drugs, and conditions or requirements 18 under subsection (b) or (k); and 19 ‘‘(iii) in a dosage form that, imme- 20 diately prior to the date of the enactment 21 of this section, has been used to a material 22 extent and for a material time under sec- 23 tion 201(p)(2). 24 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 8 S 2740 RFH ‘‘(4) CATEGORY II DRUGS DEEMED NEW 1 DRUGS.—A drug that is classified in category II for 2 safety or effectiveness under a tentative final mono- 3 graph or that is subject to a determination to be not 4 generally recognized as safe and effective in a pro- 5 posed rule that is the most recently applicable pro- 6 posal issued under part 330 of title 21, Code of Fed- 7 eral Regulations, shall be deemed to be a new drug 8 under section 201(p), misbranded under section 9 502(ee), and subject to the requirement for an ap- 10 proved new drug application under section 505 be- 11 ginning on the day that is 180 calendar days after 12 the date of the enactment of this section, unless, be- 13 fore such day, the Secretary determines that it is in 14 the interest of public health to extend the period 15 during which the drug may be marketed without 16 such an approved new drug application. 17 ‘‘(5) DRUGS NOT GRASE DEEMED NEW 18 DRUGS.—A drug that the Secretary has determined 19 not to be generally recognized as safe and effective 20 under section 201(p)(1) under a final determination 21 issued under part 330 of title 21, Code of Federal 22 Regulations, shall be deemed to be a new drug under 23 section 201(p), misbranded under section 502(ee), 24 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 9 S 2740 RFH and subject to the requirement for an approved new 1 drug application under section 505. 2 ‘‘(6) OTHER DRUGS DEEMED NEW DRUGS.— 3 Except as provided in subsection (m), a drug is 4 deemed to be a new drug under section 201(p) and 5 misbranded under section 502(ee) if the drug— 6 ‘‘(A) is not subject to section 503(b)(1); 7 and 8 ‘‘(B) is not described in paragraph (1), 9 (2), (3), (4), or (5), or subsection (b)(1)(B). 10 ‘‘(b) ADMINISTRATIVE ORDERS.— 11 ‘‘(1) IN GENERAL.— 12 ‘‘(A) DETERMINATION.—The Secretary 13 may, on the initiative of the Secretary or at the 14 request of one or more requestors, issue an ad- 15 ministrative order determining whether there 16 are conditions under which a specific drug, a 17 class of drugs, or a combination of drugs, is de- 18 termined to be— 19 ‘‘(i) not subject to section 503(b)(1); 20 and 21 ‘‘(ii) generally recognized as safe and 22 effective under section 201(p)(1). 23 ‘‘(B) EFFECT.—A drug or combination of 24 drugs shall be deemed to not require approval 25 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 10 S 2740 RFH under section 505 if such drug or combination 1 of drugs— 2 ‘‘(i) is determined by the Secretary to 3 meet the conditions specified in clauses (i) 4 and (ii) of subparagraph (A); 5 ‘‘(ii) is marketed in conformity with 6 an administrative order under this sub- 7 section; 8 ‘‘(iii) meets the general requirements 9 for nonprescription drugs; and 10 ‘‘(iv) meets the requirements under 11 subsections (c) and (k). 12 ‘‘(C) STANDARD.—The Secretary shall find 13 that a drug is not generally recognized as safe 14 and effective under section 201(p)(1) if— 15 ‘‘(i) the evidence shows that the drug 16 is not generally recognized as safe and ef- 17 fective under section 201(p)(1); or 18 ‘‘(ii) the evidence is inadequate to 19 show that the drug is generally recognized 20 as safe and effective under section 21 201(p)(1). 22 ‘‘(2) ADMINISTRATIVE ORDERS INITIATED BY 23 THE SECRETARY.— 24 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 11 S 2740 RFH ‘‘(A) IN GENERAL.—In issuing an adminis- 1 trative order under paragraph (1) upon the 2 Secretary’s initiative, the Secretary shall— 3 ‘‘(i) make reasonable efforts to notify 4 informally, not later than 2 business days 5 before the issuance of the proposed order, 6 the sponsors of drugs who have a listing in 7 effect under section 510(j) for the drugs or 8 combination of drugs that will be subject 9 to the administrative order; 10 ‘‘(ii) after any such reasonable efforts 11 of notification— 12 ‘‘(I) issue a proposed administra- 13 tive order by publishing it on the 14 website of the Food and Drug Admin- 15 istration and include in such order the 16 reasons for the issuance of such order; 17 and 18 ‘‘(II) publish a notice of avail- 19 ability of such proposed order in the 20 Federal Register; 21 ‘‘(iii) except as provided in subpara- 22 graph (B), provide for a public comment 23 period with respect to such proposed order 24 of not less than 45 calendar days; and 25 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 12 S 2740 RFH ‘‘(iv) if, after completion of the pro- 1 ceedings specified in clauses (i) through 2 (iii), the Secretary determines that it is ap- 3 propriate to issue a final administrative 4 order— 5 ‘‘(I) issue the final administrative 6 order, together with a detailed state- 7 ment of reasons, which order shall not 8 take effect until the time for request- 9 ing judicial review under paragraph 10 (3)(D)(ii) has expired; 11 ‘‘(II) publish a notice of such 12 final administrative order in the Fed- 13 eral Register; 14 ‘‘(III) afford requestors of drugs 15 that will be subject to such order the 16 opportunity for formal dispute resolu- 17 tion up to the level of the Director of 18 the Center for Drug Evaluation and 19 Research, which initially must be re- 20 quested within 45 calendar days of 21 the issuance of the order, and, for 22 subsequent levels of appeal, within 30 23 calendar days of the prior decision; 24 and 25 VerDate Sep 11 2014 00:14 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S2740.RFH S2740 pamtmann on DSKBC07HB2PROD with BILLS 13 S 2740 RFH ‘‘(IV) except with respect to 1 drugs described in paragraph (3)(B), 2 upon completion of the formal dispute 3 resolution procedure, inform the per- 4 sons which sought such dispute reso- 5 lution of their right to request a hear- 6 ing. 7 ‘‘(B) EXCEPTIONS.—When issuing an ad- 8 ministrative order under paragraph (1) on the 9 Secretary’s initiative proposing to determine 10 that a drug described in subsection (a)(3) is not 11 generally recognized as safe and effective under 12 section 201(p)(1), the Secretary shall follow the 13 procedures in subparagraph (A), except that— 14 ‘‘(i) the proposed order shall include 15 notice of— 16 ‘‘(I) the general categories of 17 data the Secretary has determined 18 necessary to e [Text truncated for display. 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