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

Published online by Cambridge University Press:  29 June 2021

Abstract

Over-the-counter (OTC) drugs are ubiquitous in the US. Policymakers have long debated how to modernize the system for making determinations of safety and effectiveness and addressing safety issues with OTC drugs.

Type
Columns: Health Policy Portal
Copyright
© 2021 The Author(s)

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Footnotes

About This Column

Aaron S. Kesselheim serves as the editor for Health Policy Portal. Dr. Kesselheim is the JLME editor-in-chief and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital/Har-vard Medical School. This column features timely analyses and perspectives on issues at the intersection of medicine, law, and health policy that are directly relevant to patient care. If you would like to submit to this section of JLME, please contact Dr. Kesselheim at [email protected].

References

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For minor changes in the dosage form of a drug that already has an administrative order, sponsors need not seek another order. 21 U.S.C. § 355(c).Google Scholar
Ingredients that would require a GRAS/E finalization order before FDA will consider an Innovation OMOR relevant to them include those described above that can continue to be marketed without a GRAS/E determination (ingredients classified as Category III in a tentative final monograph and those classified as Category I in a proposed monograph or advance notice of proposed rulemaking). See U.S. Food & Drug. Admin., Over-the-Counter Monograph User Fee Program Performance Goals and Procedures – Fiscal Years 2018-2022 at 10-12 (2020).Google Scholar
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21 U.S.C. § 379j-72. For FY 2021, the Tier 1 OMOR fee is $500,000, and the Tier 2 OMOR fee is $100,000. Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021, 86 Fed. Reg. 16,223, 16,224 (Mar. 26, 2021).Google Scholar
If increasing OTC access is associated with a decrease in physician visits, such a change may not materialize quickly, especially if patients are already seeing a physician regularly when their drug switches from prescription to over-the-counter. See Andrade, S. E. , Gurwitz, J. H., and Fish, L. S., “The Effect of an Rx-to-OTC Switch on Medication Prescribing Patterns and Utilization of Physician Services: The Case of H2-Receptor Antagonists,” Medical Care 37, no. 4 (1999): 424-430.CrossRefGoogle ScholarPubMed
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Id. For example, as discussed in Part I, as many as one-third of consumers of OTC products may take more than the recommended dose. Schulke, D. G. , “American Pharmaceutical Association Review of Literature on Prescription to Over-the-Counter Drug Switches,” Clinical Therapeutics 20 (1998): C124-C133.CrossRefGoogle ScholarPubMed
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