OTC Drug Monograph Reform Is on the Horizon

Pharmacy TimesOctober 2019 Diabetes
Volume 85
Issue 10

The success of PDUFA raises questions about additional funding to market nonprescription products.

Since its passage in 1992, the Prescription Drug User Fee Act (PDUFA) has been revolutionary in providing patients with new medical innovations in a timely manner. Under the US drug approval process, pharmaceutical companies seeking to bring a new drug to market must submit a biologics license application (BLA) or a new drug application (NDA) to the FDA for review. These are extensive documents in which the company must provide data on the new drug’s animal and human studies, pharmacology, toxicology, and other information that demonstrate the drug’s efficacy and safety.1 Prior to PDUFA’s enactment, the FDA often took more than 2 years to review applications because of a lack of staff and underfunding. This long process led to the first approval of 70% of new medications outside the United States.2

PDUFA authorizes the FDA to collect fees from drug manufacturers to fund the drug review process. These substantial fees are collected as part of the application submission fee for a BLA or an NDA and as part of the program fee, a postapproval annual fee.2 In turn, the FDA is required to review and respond to BLA and NDA submissions within a defined period. PDUFA is reauthorized every 5 years to ensure adaptation to current practices and continued timeliness of the drug development process. The most recent renewal was PDUFA VI in 2017.3 Today, the average FDA approval time for a new prescription medication is 10 months, and 78% of medications are first approved in the United States.2 This improved efficiency has greatly accelerated patient access to new medications and encouraged biopharmaceutical innovation in the country.

The success of PDUFA has triggered discussion of establishing a user fee program for OTC products. Because these products do not require a prescription, their review process does not follow PDUFA regulations. New OTC products do not need an NDA if they conform to the FDA-established OTC drug monograph for its product category; OTC products also do not require preapproval to make or market, and a postmarket review is not mandated.4 Although the number of OTC products on the market far exceeds that of prescription drugs, the OTC monograph program funding was only about $8 million in 2017, whereas the budget for prescription drugs was about $320 million.5 In addition to that congressional appropriation, the prescription drug regulatory program received about $840 million in PDUFA fees.5 The small OTC budget means the department is understaffed and can focus on just 3 areas: court-mandated requirements of the consent decree pertaining to antiseptic drug products, statutory requirements of the Sunscreen Innovation Act, and urgent safety activities.5 Under these circumstances, the OTC program has experienced difficulty in reviewing and approving new monographs, and many projects have been at a standstill for years.5

First proposed in 2016, the OTC user fee program aims to address several issues related to the OTC monograph regulatory system. Some goals of the reform are to encourage innovation; increase efficiency, predictability, and timeliness; reduce regulatory burden; and streamline safety updates.6 Like PDUFA, the OTC user fee program would authorize the FDA to collect fees from OTC drug industry companies to support certain monograph requests and fund the above goals. The first order of business would be to hire additional staff to review monographs that have been pending for years.5

In 2018, both House and Senate committees approved OTC user fee bills, and in January 2019, HR 269 was introduced in Congress.7 HR 269 addresses primarily pandemic preparedness but contains OTC reform provisions, including the estab- lishment of an OTC user fee program.7 The bill was passed in the House on January 8, and is awaiting Senate approval and will go to the president if approved.7 If the bill is enacted into law, pharmacists can expect an increase in the number of available OTC products and more efficient regulation of the OTC monograph system over the next few years. The efficiency gap between the OTC monograph system and the prescription drug review system will take considerable time to close,5 but establishment of an OTC user fee program is a step in the right direction.

Yin S. Chen is a PharmD candidate at the University of Kentucky College of Pharmacy in Lexingon.Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy.


  • New drug application (NDA). FDA website. www.fda.gov/drugs/types-applications/new-drug-application-nda. Updated June 10, 2019. Accessed June 11, 2019.
  • PDUFA. Pharmaceutical Research and Manufacturers of America website. phrma.org/advocacy/research-development/pdufa. Accessed June 10, 2019.
  • Ezell SJ. How the Prescription Drug User Fee Act supports life-sciences innovation and speeds cures. Information Technology & Innovation Foundation website. www2.itif.org/2017-pdufa-life-sciences-innovation.pdf. Published February 2017. Accessed June 13, 2019.
  • Drug applications for over-the-counter (OTC) drugs. FDA website. www.fda.gov/drugs/types-applications/drug-applications-over-counter-otc-drugs. Updated January 7, 2015. Accessed June 14, 2019.
  • Barlas S. Congress readying user fee program for OTC products: money needed to dig FDA out of its review ditch. P T. 2018;43(9):541-568.
  • Over-the-counter monograph user fees — stakeholder webinar. FDA website. www.fda.gov/media/109881/download. Published August 23, 2017. Accessed June 14, 2019.
  • Over-the-counter (OTC) [PS1] monograph reform momentum strong in 2019: federal legislation update in the new 116th Congress. Arnall Golden Gregory website. agg.com/Over-the-Counter-OTC-Monograph-Reform-Momentum-Strong-in-2019-Federal-Legislation-Update-in-the-New-116th-Congress-02-15-2019/. Published February 15, 2019 .Accessed June 14, 2019.

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