Michele, T. M., “An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act,” FDA, available at <www.fda.gov/news-events/fda-voices/exciting-new-chapter-otc-drug-history-otc-monograph-reform-cares-act> (last visited May 6, 2021).+(last+visited+May+6,+2021).>Google Scholar

Richardson, L., “Congress Passes Legislation to Reform Over-the-Counter Drug Regulation,” Pew Trusts, March 27, 2020, available at <https://www.pewtrusts.org/en/research-and-analysis/articles/2020/03/27/congress-passes-legislation-to-reform-over-the-counter-drug-regulation> (last visited May 6, 2021).+(last+visited+May+6,+2021).>Google Scholar

See Brass, E. P. , “Changing the Status of Drugs from Prescription to Over-the-Counter Availability,” New England Journal of Medicine 345 (2001): 810-816.CrossRefGoogle ScholarPubMed

Harrington, P. and Shepherd, M. D., “Analysis of the Movement of Prescription Drugs to Over-the-Counter Status,” Journal of Managed Care Pharmacy 8 (2002): 499-508.CrossRefGoogle ScholarPubMed

Greene, J. A. et al., “Changes in Direct-to-Consumer Pharmaceutical Advertising Following Shifts from Prescription-Only to Over-the-Counter Status,” JAMA 308 (2012): 973-975.10.1001/2012.jama.10647CrossRefGoogle ScholarPubMed

See Kaplan, A. H. et al., “Over-the-Counter Drugs,” in Volume 2 of Fundamentals of Law and Regulation: An In-Depth Look at Therapeutic Products, Adams, D. G. et al. eds. (FDLI, 1997).Google Scholar

Advisory review panels are composed of experts appointed by the FDA Commissioner and may include persons recommended by professional, consumer, or industry organizations. 21 C.F.R. § 330.10(a)(1).Google Scholar

Food and Drug Administration, “Drug Applications for Over-the-Counter (OTC) Drugs,” available at <www.fda.gov/drugs/types-applications/drug-applications-over-counter-otc-drugs> (last visited May 6, 2021).+(last+visited+May+6,+2021).>Google Scholar

Id.Google Scholar

Modernizing FDA’s Regulation of Over-the-Counter Drugs: Hearing Before the Subcomm. on Health of the H. Comm. On Energy and Commerce, 115th Cong. 18 (2017) (statement of Janet Woodcock, Director, Center for Drug Evaluation and Research).Google Scholar

See Motor Vehicle Manufacturers’ Ass’n v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29, 42-43 (1983) (holding that agencies must consider all relevant evidence and important aspects of a problem to pass muster under the arbitrary and capricious standard of the Administrative Procedure Act).Google Scholar

Memorandum from H. Comm. On Energy and Commerce Democratic Staff to Subcomm. on Health Democratic Members and Staff Re: Hearing on “Modernizing FDA’s Regulation of Over-the-Counter Drugs,” Sept. 11, 2017.Google Scholar

Id. (citing FDA, “Frequently Asked Questions: June 10, 2016 Public Meeting on OTC Monograph User Fees,” available at <https://www.fda.gov/drugs/news-events-human-drugs/frequently-asked-questions-june-10-2016-public-meeting-otc-monograph-user-fees> (last visited May 6, 2021); FDA, FY 2016 PDUFA Financial Report, available at <https://www.fda.gov/about-fda/pdufa-financial-reports/fy-2016-pdufa-financial-report (last visited May 6, 2021).+(last+visited+May+6,+2021);+FDA,+FY+2016+PDUFA+Financial+Report,+available+at+Google Scholar

See Modernizing FDA’s Regulation of Over-the-Counter Drugs: Hearing Before the Subcomm. on Health of the H. Comm. On Energy and Commerce, 115th Cong. 103 (2017) (statement of Kirsten Moore, Pew Charitable Trusts).Google Scholar

44 Fed. Reg. 69768 (Dec. 4, 1979); see also FDA, “Rulemaking History for OTC External Analgesic Drug Prod-ucts,” available at <https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-external-analgesic-drug-products> (last visited May 6, 2021).+(last+visited+May+6,+2021).>Google Scholar

57 Fed. Reg. 27654 (Jun. 19, 1992); 57 Fed. Reg. 60426 (Dec. 18, 1992).Google Scholar

62 Fed. Reg. 61710 (Nov. 19, 1997); see also Modernizing FDA’s Regulation of Over-the-Counter Drugs: Hearing Before the Subcomm. on Health of the H. Comm. On Energy and Commerce, 115th Cong. 18 (2017) (statement of Janet Woodcock, Director, Center for Drug Evaluation and Research); see also FDA, “Rulemaking History for OTC External Analgesic Drug Prod-ucts,” available at <https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-external-analgesic-drug-products> (last visited May 6, 2021).+(last+visited+May+6,+2021).>Google Scholar

Modernizing FDA’s Regulation of Over-the-Counter Drugs: Hearing Before the Subcomm. on Health of the H. Comm. On Energy and Commerce, 115th Cong. 10 (2017) (statement of Janet Woodcock, Director, Center for Drug Evaluation and Research).Google Scholar

Spangler, D. C. and Rathore, R., “OTC Monograph Reform Legislation is Now Law—What Does It Do?” FDLI Update Magazine (summer 2020), available at <https://www.fdli.org/2020/05/otc-monograph-reform-legislation-is-now-law-what-does-it-do/> (last visited May 6, 2021). See also “Status of OTC Rulemakings,” FDA.gov, available at <https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/status-otc-rulemakings> (last visited May 6, 2021).+(last+visited+May+6,+2021).+See+also+“Status+of+OTC+Rulemakings,”+FDA.gov,+available+at++(last+visited+May+6,+2021).>Google Scholar

See D. C. Spangler and R. Rathore, supra note 19.Google Scholar

Sharfstein, J. M., North, M., and Serwint, J. R., “Over the Counter but No Longer Under the Radar — Pediatric Cough and Cold Medications,” New England Journal of Medicine 357 (2007): 2321, available at <https://www.nejm.org/doi/full/10.1056/NEJMp0707400> (last visited May 6, 2021).CrossRefGoogle ScholarPubMed

Dicken, J. E., Over-the-Counter Drugs: Information on FDA’s Regulation of Most OTC Drugs, Gov’t Accountability Office, July 2020, available at <https://www.gao.gov/assets/710/708474.pdf> (last visited May 6, 2021). See also Modernizing FDA’s Regulation of Over-the-Counter Drugs: Hearing Before the Subcomm. on Health of the H. Comm. On Energy and Commerce, 115th Cong. 5 (2017) (statement of Rep. Diana DeGette).+(last+visited+May+6,+2021).+See+also+Modernizing+FDA’s+Regulation+of+Over-the-Counter+Drugs:+Hearing+Before+the+Subcomm.+on+Health+of+the+H.+Comm.+On+Energy+and+Commerce,+115th+Cong.+5+(2017)+(statement+of+Rep.+Diana+DeGette).>Google Scholar

Modernizing FDA’s Regulation of Over-the-Counter Drugs: Hearing Before the Subcomm. on Health of the H. Comm. On Energy and Commerce, 115th Cong. 103 (2017) (statement of Kirsten Moore, Pew Charitable Trusts); 21 C.F.R. § 341.14. As part of the new monograph reform legislation discussed here, the FDA is required to submit annual reports to Congress on the status of the monograph update. Pub. L. 116-136 § 3855, codified at 21 U.S.C. § 355h note.Google Scholar

Modernizing FDA’s Regulation of Over-the-Counter Drugs: Hearing Before the Subcomm. on Health of the H. Comm. On Energy and Commerce, 115th Cong. 19-20, 70-71 (2017) (statement of Janet Woodcock, Director, Center for Drug Evaluation and Research); Dicken, supra note 22.Google Scholar

Budnitz, D. S., Lovegrove, M. C., Rose, K. O., “Adherence to Label and Device Recommendations for Over-the-Counter Pediatric Liquid Medications,” Pediatrics 133, no. 2 (2014): e283-e290, available at <https://doi.org/10.1542/peds.2013-2362> (last visited May 6, 2021).CrossRefGoogle ScholarPubMed

See, e.g., Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen; Draft Guidance for Industry; Availability, 79 Fed. Reg. 60854-01 (Oct. 8, 2014).Google Scholar

See Over-the-Counter Drug Safety, Innovation, and Reform Act, S. 2315, 115th Cong. (2018); Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, H.R. 5333, 115th Cong.; Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, H.R. 3443, 116th Cong.; Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, S. 2740, 116th Cong.Google Scholar

21 U.S.C. § 355h(a). See also H.R. Rep. No. 115-827, at 47 (2018).Google Scholar

If these drugs are the subject of a GRAS/E finalization administrative order (see 21 U.S.C. § 355h(b)(5)(B)(i) (II)(aa)), their conditions may thereafter be modified by other administrative orders, following the process described below. See infra note 34.Google Scholar

21 U.S.C. § 355h(b)(1)(A).Google Scholar

21 U.S.C. § 355h(b)(2)-(3).Google Scholar

21 U.S.C. § 355h(b)(4).Google Scholar

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

U.S. Food & Drug. Admin., Over-the-Counter Monograph User Fee Program Performance Goals and Procedures – Fiscal Years 2018-2022 at 10-11, 13 (2020).Google Scholar

21 U.S.C. § 355h(b)(5).Google Scholar

21 USCA § 379j-71(10). For FY 2021, facility fees are $20,322 and $13,548, depending on the type of facility. 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

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

Brass, E.P., “Changing the Status of Drugs from Prescription to Over-the-Counter Availability,” New England Journal of Medicine 345 (2001): 810.10.1056/NEJMra011080CrossRefGoogle ScholarPubMed

Id. Google Scholar

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

Hilzenrath, D. S., “Coronavirus Relief Act Gives Drug Makers New Sway over FDA,” Project on Gov’t Oversight, May 5, 2020, available at <https://www.pogo.org/investigation/2020/05/coronavirus-relief-act-gives-drug-makers-new-sway-over-fda/> (last visited May 6, 2021).+(last+visited+May+6,+2021).>Google Scholar

Harrington and Shepherd, supra note 4.Google Scholar