ENHANCING OTC MONOGRAPH DRUG REGULATION THROUGH USER FEE PROGRAM
DOI:
https://doi.org/10.22159/ijpps.2024v16i5.49167Keywords:
FDA, OMUFA, OTC medications, User fees, Efficacy, Safety standardsAbstract
Food and Drug Administration (FDA) has introduced a distinctive regulatory program known as Over-the-Counter Monograph Drug User Fee Program (OMUFA) to improve the efficacy and security of over-the-counter (OTC) medications made available to consumers. The program, which represents a pivotal shift in the regulatory landscape, aims to address the challenges associated with the oversight of OTC monograph drugs. The OMUFA's primary objective is to expedite the review and approval process of OTC monograph drugs while maintaining stringent safety standards. By imposing user fees on manufacturers and sponsors seeking to bring new OTC products to market or seeking updates for existing ones, the program is designed to support the FDA's ability to allocate additional resources for timely reviews and assessments. This work delves into the key components and mechanics of the OMUFA, such as the user fee structure, types of submissions covered, and the corresponding performance goals established for the FDA. While acknowledging the benefits of the OMUFA, this work also discusses potential challenges and concerns raised by industry stakeholders and consumer advocacy groups. This critical regulatory initiative has the potential to facilitate further research and discussions on optimizing drug safety and access within the OTC market through required modifications and initiatives.
Downloads
References
Over-The-Counter Monograph Drug User Fee Program (OMUFA) | FDA. Available from: https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa [Last accessed on 16 Aug 2023]
Modernizing fda’s regulation of over-the-counter drugs. Release only upon delivery; 2017. Available from: www.fda.gov [Last accessed on 16 Aug 2023]
Yajun Tu, Manager P, Program Manager G. OTC monograph drug user fee program (OMUFA): Understanding FY 2023 user fees LCDR tramara dam; 2023. Available from: www.fda.gov [Last accessed on 16 Aug 2023]
FDA draft guidance: everything you may want to know about OMUFA fees. Available from: https://www.thefdalawblog.com/2022/11/fda-draft-guidance-everything-you-may-want-to-know-about-omufa-fees/ [Last accessed on 16 Aug 2023]
Barlas S. Over-the-counter products in line for user fee program. Pharmacy and Therapeutics. 2017 Dec 1;42(12):723. Available from: pmc/articles/PMC5720481/ [Last accessed on 16 Aug 2023]
Federal register: fee rates under the over-the-counter monograph drug user fee program for fiscal year; 2021. Available from: https://www.federalregister.gov/documents/2021/03/26/2021-06361/fee-rates-under-the-over-the-counter-monograph-drug-user-fee-program-for-fiscal-year-2021 [Last accessed on 16 Aug 2023]
Barlas S. Congress readying user fee program for otc products: money needed to dig fda out of its review ditch. Pharmacy and Therapeutics. 2018 Sep 1;43(9):541. Available from: pmc/articles/PMC6110644/ [Last accessed on 16 Aug 2023]
Duane Morris LLP-CARES act package ushers in changes to OTC drug review process. Available from: https://www.duanemorris.com/alerts/cares_act_package_ushers_changes_otc_drug_review_process_0420.html [Last accessed on 16 Aug 2023]
Modernizing FDA’s regulation of over-the-counter drugs | FDA. Available from: https://www.fda.gov/news-events/congressional-testimony/modernizing-fdas-regulation-over-counter-drugs [Last accessed on 16 Aug 2023]
FDA reissues notice announcing increased otc monograph facility fees | womble bond dickinson. Available from: https://www.womblebonddickinson.com/us/insights/blogs/fda-reissues-notice-announcing-increased-otc-monograph-facility-fees [Last accessed on 16 Aug 2023]
Assessing user fees under the over-the-counter monograph drug user fee program | FDA. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-over-counter-monograph-drug-user-fee-program [Last accessed on 16 Aug 2023]
OTC monograph reform legislation is now law—what does it do?-food and Drug Law Institute (FDLI). Available from: https://www.fdli.org/2020/05/otc-monograph-reform-legislation-is-now-law-what-does-it-do/ [Last accessed on 16 Aug 2023]
FD and C Act section 505G (21 U. S. C. 355 h) (FD and C Act section 74 4 L(5)).-Google Search. Available from: https://www.google.com/search?q=FD%26C+Act+section+505G+(21+U.S.C.+355h)+(FD%26C+Act+section+744L(5)).andrlz=1C1RXQR_enIN1019IN1019andoq=FD%26C+Act+section+505G+(21+U.S.C.+355h)+(FD%26C+Act+section+744L(5)). andaqs=chrome.69i57.1101091836j0j15andsourceid=chromeandie=UTF-8
Barlas S. Over-the-counter products in line for user fee program. Pharmacy and Therapeutics. 2017 Dec 1;42(12):723. Available from: pmc/articles/PMC5720481/ [Last accessed on 16 Aug 2023]
Sen Isakson J. R G. Text-S.2740-116th Congress (2019-2020): Over-the-counter monograph safety, innovation, and reform act of 2019; 2019. Available from: http://www.congress.gov/bill/116th-congress/senate-bill/2740/text [Last accessed on 16 Aug 2023]
US Food and Drug Administration. Sec. 201 federal food, drug, and cosmetic act. United States of America: US Food and Drug Administration. Available from: https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf [Last accessed on 16 Aug 2023]
FDA: User fees explained | FDA. Available from: https://www.fda.gov/industry/fda-user-fee-programs/fda-user-fees-explained [Last accessed on 16 Aug 2023]
Over-the-counter monograph drug user fee program (OMUFA) | FDA. Available from: https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa [Last accessed on 16 Aug 2023]
FDA Announces OTC monograph drug facility user fees for 2022-registrar corp. Available from: https://www.registrarcorp.com/blog/fda-announces-otc-monograph-drug-facility-user-fees-for-2022/ [Last accessed on 16 Aug 2023]
OMUFA 2022 features fee spike for some facilities | RAPS. Available from: https://www.raps.org/news-and-articles/news-articles/2022/3/OMUFA-2022-features-fee-spike-for-some-facilities [Last accessed on 16 Aug 2023]
FDA Announces OTC monograph drug facility user fees for 2022-registrar corp. Available from: https://www.registrarcorp.com/blog/fda-announces-otc-monograph-drug-facility-user-fees-for-2022/
OTC drug user facility fees–don’t miss the changes: wiley. Available from: https://www.wiley.law/alert-otc-drug-user-facility-fees-due-soon-dont-miss-the-changes [Last accessed on 16 Aug 2023]
FEI Search Portal. Available from: https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login. [Last accessed on 16 Aug 2023]
US-FDA over-the-counter monograph drug user fee program (OMUFA). Available from: https://globalregulatorypartners.com/us-fda-over-the-counter-monograph-drug-user-fee-program-omufa/ [Last accessed on 16 Aug 2023]
Office of nonprescription drugs | FDA. Available from: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-nonprescription-drugs [Last accessed on 16 Aug 2023]
Guidance D. Assessing user fees under the over-the-counter monograph drug user fee program guidance for industry. Available from: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm [Last accessed on 16 Aug 2023]
Assessing user fees under the over-the-counter monograph drug user fee program | FDA. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-over-counter-monograph-drug-user-fee-program [Last accessed on 16 Aug 2023]
Federal register: revision of fee schedules; fee recovery for fiscal year 2023. Available from: https://www.federalregister.gov/documents/2023/06/15/2023-12696/revision-of-fee-schedules-fee-recovery-for-fiscal-year-2023 [Last accessed on 16 Aug 2023]
Other OMUFA fee-related questions | FDA. Available from: https://www.fda.gov/industry/over-counter-monograph-drug-user-fee-program-omufa/other-omufa-fee-related-questions [Last accessed on 16 Aug 2023]
FDA publishes new otc monograph drug facility user fees-registrar corp. Available from: https://www.registrarcorp.com/blog/fda-publishes-new-otc-monograph-drug-facility-user-fees/ [Last accessed on 16 Aug 2023]
US food and drug administration. Sec. 201 federal food, drug, and cosmetic act. United States of America: US food and drug administration. Available from: https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf
USC Chapter 9, Subchapter VII, Part C: fees. Available from: https://uscode.house.gov/view.xhtml?edition=prelimandpath=%2Fprelim%40title21%2Fchapter9%2Fsubchapter7%2FpartC
Registration Process | Registration Guide | Registration Guide. Available from: https://www.uaf.edu/handbook/register/process/index.php
FDA drafts guidance on formal meetings with OTC sponsors | RAPS. Available from: https://www.raps.org/news-and-articles/news-articles/2022/2/fda-drafts-guidance-on-formal-meetings-with-otc-sp
Modernizing fda’s regulation of over-the-counter drugs. Available from: https://www.govinfo.gov/content/pkg/CHRG-115hhrg27228/html/CHRG-115hhrg27228.htm [Last accessed on 16 Aug 2023]
FAQs About OTC monograph reform for manufacturers | Consumer Healthcare Products Association. Available from: https://www.chpa.org/about-consumer-healthcare/faqs/faqs-about-otc-monograph-reform-manufacturers [Last accessed on 16 Aug 2023] [Last accessed on 16 Aug 2023]
OMUFA fee liable’ trending in US OTC drug industry to pay for FDA’s monograph reform: HBW insight. Available from: https://hbw.pharmaintelligence.informa.com/RS151402/OMUFA-fee-liable-trending-in-us-otc-drug-industry-to-pay-for-FDAs-monograph-reform [Last accessed on 16 Aug 2023]
[Solved] If a manufacturing company does not adhere to CGMP regulatio. Available from: https://testbook.com/question-answer/if-a-manufacturing-company-does-not-adhere-to-cgmp--61729281ab1eceeb2372b6f5
FDA User Fee Programs | FDA. Available from: https://www.fda.gov/industry/fda-user-fee-programs [Last accessed on 16 Aug 2023]
Reports, manuals, and forms | FDA. Available from: https://www.fda.gov/about-fda/reports-manuals-forms [Last accessed on 16 Aug 2023]
Requests for reconsideration at the division level under GDUFA guidance for Industry | FDA. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-reconsideration-division-level-under-gdufa-guidance-industry
Center for Drug Evaluation and Research | CDER | FDA. Available from: https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder [Last accessed on 16 Aug 2023]
CDER formal dispute resolution | FDA. Available from: https://www.fda.gov/about-fda/cder-contact-information/cder-formal-dispute-resolution [Last accessed on 16 Aug 2023]
Forms needed for your level 3 appeal | HHS.gov. Available from: https://www.hhs.gov/about/agencies/omha/filing-an-appeal/forms/index.html [Last accessed on 16 Aug 2023]
CDER contact information | FDA. Available from: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-contact-information
US FDA allows multiple OMUFA refund appeals: HBW insight. Available from: https://hbw.pharmaintelligence.informa.com/RS153071/US-FDA-Allows-Multiple-OMUFA-refund-appeals [Last accessed on 16 Aug 2023]
Published
How to Cite
Issue
Section
Copyright (c) 2024 CHANDANA A. N., SANGITHA MISHRA, ARJUN M., M. P. VENKATESH
This work is licensed under a Creative Commons Attribution 4.0 International License.
