3.0.0 3443 2022-11-01T13:50:57Z 2022-11-01T13:50:57Z House HR 2019-06-24 116 [Congressional Record Volume 165, Number 106 (Monday, June 24, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. DeGETTE:H.R. 3443.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3[Page H5076]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-06-25T19:23:14Z Referred to 2019-06-24T16:02:05Z Lower Costs, More Cures Act of 2019 116 19 HR 2019-12-19 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Related bill CRS Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 116 2740 S 2019-12-14 Referred to the Subcommittee on Health. Related bill CRS CARES Act 116 748 HR 2020-07-23 Committee on Small Business and Entrepreneurship. Hearings held. Related bill CRS Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 116 269 HR 2019-01-10 Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 10. Related bill CRS 2019-07-24 Sponsor introductory remarks on measure. (CR E971) IntroReferral B00100 9 Library of Congress 2019-06-25 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-06-24 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-06-24 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-06-24 Introduced in House IntroReferral 1000 9 Library of Congress D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 N L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2019-06-24 True D000624 Rep. Dingell, Debbie [D-MI-12] Debbie Dingell D MI 12 2019-06-24 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2019-06-24 True Health Administrative law and regulatory procedures Administrative remedies Child health Congressional oversight Cosmetics and personal care Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government information and archives Government studies and investigations Inflation and prices Judicial review and appeals Marketing and advertising User charges and fees Health 00 2019-06-24 Introduced in House 2021-09-13T16:34:30Z Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.

The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.

The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.

The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.

The FDA must establish a user fee program for OTC drugs.

]]>

To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. Display Title To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. Official Title as Introduced To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. Introduced in House IH Short Title(s) as Introduced for portions of this bill Over-the-Counter Monograph User Fee Act of 2019 Introduced in House IH Introduced in House 2019-06-24T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr3443ih/xml/BILLS-116hr3443ih.xml 2019-07-24 Sponsor introductory remarks on measure. (CR E971) text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.