To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.

I 116TH CONGRESS 1ST SESSION H. R. 3443 To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JUNE 24, 2019 Ms. DEGETTE (for herself, Mr. LATTA, Mrs. DINGELL, and Mr. GUTHRIE) introduced the following bill; which was referred to the Committee on En- ergy and Commerce A BILL To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an ap- proved 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 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Over-the-Counter Monograph Safety, Innovation, and 5 Reform Act of 2019’’. 6 (b) TABLE OF CONTENTS.—The table of contents for 7 this Act is as follows: 8 Sec. 1. Short title; table of contents. VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 3443 IH TITLE I—OTC DRUG REVIEW Sec. 1001. Regulation of certain nonprescription drugs that are marketed with- out an approved drug application. Sec. 1002. Misbranding. Sec. 1003. Drugs excluded from the over-the-counter drug review. Sec. 1004. Treatment of Sunscreen Innovation Act. Sec. 1005. Annual update to Congress on appropriate pediatric indication for certain OTC cough and cold drugs. Sec. 1006. Technical corrections. TITLE II—USER FEES Sec. 2001. Short title; finding. Sec. 2002. Fees relating to over-the-counter drugs. TITLE I—OTC DRUG REVIEW 1 SEC. 1001. REGULATION OF CERTAIN NONPRESCRIPTION 2 DRUGS THAT ARE MARKETED WITHOUT AN 3 APPROVED DRUG APPLICATION. 4 (a) IN GENERAL.—Chapter V of the Federal Food, 5 Drug, and Cosmetic Act is amended by inserting after sec- 6 tion 505F of such Act (21 U.S.C. 355g) the following: 7 ‘‘SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION 8 DRUGS THAT ARE MARKETED WITHOUT AN 9 APPROVED DRUG APPLICATION. 10 ‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITH- 11 OUT AN APPROVED APPLICATION.—Nonprescription 12 drugs marketed without an approved drug application 13 under section 505, as of the date of the enactment of this 14 section, shall be treated in accordance with this sub- 15 section. 16 ‘‘(1) DRUGS SUBJECT TO A FINAL MONOGRAPH; 17 CATEGORY I DRUGS SUBJECT TO A TENTATIVE 18 FINAL MONOGRAPH.—A drug is deemed to be gen- 19 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 3443 IH erally recognized as safe and effective under section 1 201(p)(1), not a new drug under section 201(p), and 2 not subject to section 503(b)(1), if— 3 ‘‘(A) the drug is— 4 ‘‘(i) in conformity with the require- 5 ments for nonprescription use of a final 6 monograph issued under part 330 of title 7 21, Code of Federal Regulations (except as 8 provided in paragraph (2)), the general re- 9 quirements for nonprescription drugs, and 10 conditions or requirements under sub- 11 sections (b), (c), and (k); and 12 ‘‘(ii) except as permitted by an order 13 issued under subsection (b) or, in the case 14 of a minor change in the drug, in con- 15 formity with an order issued under sub- 16 section (c), in a dosage form that, imme- 17 diately prior to the date of the enactment 18 of this section, has been used to a material 19 extent and for a material time under sec- 20 tion 201(p)(2); or 21 ‘‘(B) the drug is— 22 ‘‘(i) classified in category I for safety 23 and effectiveness under a tentative final 24 monograph that is the most recently appli- 25 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 3443 IH cable proposal or determination issued 1 under part 330 of title 21, Code of Federal 2 Regulations; 3 ‘‘(ii) in conformity with the proposed 4 requirements for nonprescription use of 5 such tentative final monograph, any appli- 6 cable subsequent determination by the Sec- 7 retary, the general requirements for non- 8 prescription drugs, and conditions or re- 9 quirements under subsections (b), (c), and 10 (k); and 11 ‘‘(iii) except as permitted by an order 12 issued under subsection (b) or, in the case 13 of a minor change in the drug, in con- 14 formity with an order issued under sub- 15 section (c), in a dosage form that, imme- 16 diately prior to the date of the enactment 17 of this section, has been used to a material 18 extent and for a material time under sec- 19 tion 201(p)(2). 20 ‘‘(2) TREATMENT OF SUNSCREEN DRUGS.— 21 With respect to sunscreen drugs subject to this sec- 22 tion, the applicable requirements in terms of con- 23 formity with a final monograph, for purposes of 24 paragraph (1)(A)(i), shall be the requirements speci- 25 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 3443 IH fied in part 352 of title 21, Code of Federal Regula- 1 tions, as published on May 21, 1999, beginning on 2 page 27687 of volume 64 of the Federal Register, 3 except that the applicable requirements governing ef- 4 fectiveness and labeling shall be those specified in 5 section 201.327 of title 21, Code of Federal Regula- 6 tions. 7 ‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN- 8 TATIVE FINAL MONOGRAPH; CATEGORY I DRUGS 9 SUBJECT TO PROPOSED MONOGRAPH OR ADVANCE 10 NOTICE OF PROPOSED RULEMAKING.—A drug that 11 is not described in paragraph (1), (2), or (4) is not 12 required to be the subject of an application approved 13 under section 505, and is not subject to section 14 503(b)(1), if— 15 ‘‘(A) the drug is— 16 ‘‘(i) classified in category III for safe- 17 ty or effectiveness in the preamble of a 18 proposed rule establishing a tentative final 19 monograph that is the most recently appli- 20 cable proposal or determination for such 21 drug issued under part 330 of title 21, 22 Code of Federal Regulations; 23 ‘‘(ii) in conformity with— 24 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 6 •HR 3443 IH ‘‘(I) the conditions of use, includ- 1 ing indication and dosage strength, if 2 any, described for such category III 3 drug in such preamble or in an appli- 4 cable subsequent proposed rule; 5 ‘‘(II) the proposed requirements 6 for drugs classified in such tentative 7 final monograph in category I in the 8 most recently proposed rule estab- 9 lishing requirements related to such 10 tentative final monograph and in any 11 final rule establishing requirements 12 that are applicable to the drug; and 13 ‘‘(III) the general requirements 14 for nonprescription drugs and condi- 15 tions or requirements under sub- 16 section (b) or (k); and 17 ‘‘(iii) in a dosage form that, imme- 18 diately prior to the date of the enactment 19 of this section, had been used to a material 20 extent and for a material time under sec- 21 tion 201(p)(2); or 22 ‘‘(B) the drug is— 23 ‘‘(i) classified in category I for safety 24 and effectiveness under a proposed mono- 25 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 7 •HR 3443 IH graph or advance notice of proposed rule- 1 making that is the most recently applicable 2 proposal or determination for such drug 3 issued under part 330 of title 21, Code of 4 Federal Regulations; 5 ‘‘(ii) in conformity with the require- 6 ments for nonprescription use of such pro- 7 posed monograph or advance notice of pro- 8 posed rulemaking, any applicable subse- 9 quent determination by the Secretary, the 10 general requirements for nonprescription 11 drugs, and conditions or requirements 12 under subsection (b) or (k); and 13 ‘‘(iii) in a dosage form that, imme- 14 diately prior to the date of the enactment 15 of this section, has been used to a material 16 extent and for a material time under sec- 17 tion 201(p)(2). 18 ‘‘(4) CATEGORY II DRUGS DEEMED NEW 19 DRUGS.—A drug that is classified in category II for 20 safety or effectiveness under a tentative final mono- 21 graph or that is subject to a determination to be not 22 generally recognized as safe and effective in a pro- 23 posed rule that is the most recently applicable pro- 24 posal issued under part 330 of title 21, Code of Fed- 25 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 8 •HR 3443 IH eral Regulations, shall be deemed to be a new drug 1 under section 201(p), misbranded under section 2 502(ee), and subject to the requirement for an ap- 3 proved new drug application under section 505 be- 4 ginning on the day that is 180 calendar days after 5 the date of the enactment of this section, unless, be- 6 fore such day, the Secretary determines that it is in 7 the interest of public health to extend the period 8 during which the drug may be marketed without 9 such an approved new drug application. 10 ‘‘(5) DRUGS NOT GRASE DEEMED NEW 11 DRUGS.—A drug that the Secretary has determined 12 not to be generally recognized as safe and effective 13 under section 201(p)(1) under a final determination 14 issued under part 330 of title 21, Code of Federal 15 Regulations, shall be deemed to be a new drug under 16 section 201(p), misbranded under section 502(ee), 17 and subject to the requirement for an approved new 18 drug application under section 505. 19 ‘‘(6) OTHER DRUGS DEEMED NEW DRUGS.— 20 Except as provided in subsection (m), a drug is 21 deemed to be a new drug under section 201(p) and 22 misbranded under section 502(ee) if the drug— 23 ‘‘(A) is not subject to section 503(b)(1); 24 and 25 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 9 •HR 3443 IH ‘‘(B) is not described in paragraph (1), 1 (2), (3), (4), or (5), or subsection (b)(1)(B). 2 ‘‘(b) ADMINISTRATIVE ORDERS.— 3 ‘‘(1) IN GENERAL.— 4 ‘‘(A) DETERMINATION.—The Secretary 5 may, on the initiative of the Secretary or at the 6 request of one or more requestors, issue an ad- 7 ministrative order determining whether there 8 are conditions under which a specific drug, a 9 class of drugs, or a combination of drugs, is de- 10 termined to be— 11 ‘‘(i) not subject to section 503(b)(1); 12 and 13 ‘‘(ii) generally recognized as safe and 14 effective under section 201(p)(1). 15 ‘‘(B) EFFECT.—A drug or combination of 16 drugs shall be deemed to not require approval 17 under section 505 if such drug or combination 18 of drugs— 19 ‘‘(i) is determined by the Secretary to 20 meet the conditions specified in clauses (i) 21 and (ii) of subparagraph (A); 22 ‘‘(ii) is marketed in conformity with 23 an administrative order under this sub- 24 section; 25 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 10 •HR 3443 IH ‘‘(iii) meets the general requirements 1 for nonprescription drugs; and 2 ‘‘(iv) meets the requirements under 3 subsections (c) and (k). 4 ‘‘(C) STANDARD.—The Secretary shall find 5 that a drug is not generally recognized as safe 6 and effective under section 201(p)(1) if— 7 ‘‘(i) the evidence shows that the drug 8 is not generally recognized as safe and ef- 9 fective under section 201(p)(1); or 10 ‘‘(ii) the evidence is inadequate to 11 show that the drug is generally recognized 12 as safe and effective under section 13 201(p)(1). 14 ‘‘(2) ADMINISTRATIVE ORDERS INITIATED BY 15 THE SECRETARY.— 16 ‘‘(A) IN GENERAL.—In issuing an adminis- 17 trative order under paragraph (1) upon the 18 Secretary’s initiative, the Secretary shall— 19 ‘‘(i) make reasonable efforts to notify 20 informally, not later than 2 business days 21 before the issuance of the proposed order, 22 the sponsors of drugs who have a listing in 23 effect under section 510(j) for the drugs or 24 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 11 •HR 3443 IH combination of drugs that will be subject 1 to the administrative order; 2 ‘‘(ii) after any such reasonable efforts 3 of notification— 4 ‘‘(I) issue a proposed administra- 5 tive order by publishing it on the 6 website of the Food and Drug Admin- 7 istration and include in such order the 8 reasons for the issuance of such order; 9 and 10 ‘‘(II) publish a notice of avail- 11 ability of such proposed order in the 12 Federal Register; 13 ‘‘(iii) except as provided in subpara- 14 graph (B), provide for a public comment 15 period with respect to such proposed order 16 of not less than 45 calendar days; and 17 ‘‘(iv) if, after completion of the pro- 18 ceedings specified in clauses (i) through 19 (iii), the Secretary determines that it is ap- 20 propriate to issue a final administrative 21 order— 22 ‘‘(I) issue the final administrative 23 order, together with a detailed state- 24 ment of reasons, which order shall not 25 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 12 •HR 3443 IH take effect until the time for request- 1 ing judicial review under paragraph 2 (3)(D)(ii) has expired; 3 ‘‘(II) publish a notice of such 4 final administrative order in the Fed- 5 eral Register; 6 ‘‘(III) afford requestors of drugs 7 that will be subject to such order the 8 opportunity for formal dispute resolu- 9 tion up to the level of the Director of 10 the Center for Drug Evaluation and 11 Research, which initially must be re- 12 quested within 45 calendar days of 13 the issuance of the order, and, for 14 subsequent levels of appeal, within 30 15 calendar days of the prior decision; 16 and 17 ‘‘(IV) except with respect to 18 drugs described in paragraph (3)(B), 19 upon completion of the formal dispute 20 resolution procedure, inform the per- 21 sons which sought such dispute reso- 22 lution of their right to request a hear- 23 ing. 24 VerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443 pamtmann on DSKBFK8HB2PROD with BILLS 13 •HR 3443 IH ‘‘(B) EXCEPTIONS.—When issuing an ad- 1 ministrative order under paragraph (1) on the 2 Secretary’s initiative proposing to determine 3 that a drug described in subsection (a)(3) is not 4 generally recognized as safe and effective under 5 section 201(p)(1), the [Text truncated for display. 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