United States: Pending OTC Drug Bill Seeks To Reform 50-Year-Old FDA Review Process

Last Updated: July 18 2019
Article by Sallie Papajohn


For years Congress has been working towards over-the-counter ("OTC") drug monograph reform.[1] And just last year, it looked like Congress' efforts would finally pay off when the Over-the-Counter Drug Safety, Innovation, and Reform Act of 2018 was passed in the House and was poised to go in front of the Senate at large on July 17, 2018.[2] Unfortunately, because of the partial government shutdown near the end of the 115th Congressional session, the bill died in the Senate and was wiped from the new Congress' books.[3] But this year, backed by overwhelming bipartisan support, the bill was incorporated into the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 and was immediately passed in the House of Representatives.[4] As of June 25, 2019, the bill remains on the Senate's Legislative Calendar under General Orders.[5]

FDA monograph PROCESS

If it eventually passes, the new bill will reform the FDA's previous OTC drugs reviewing process referred to as monograph, which is almost 50 years old. The monograph process, implemented in 1972, can be broken down into three phases, with each phase demanding a Federal Registrar publication: (1) advisory review panels tasked with analyzing the active ingredients in OTC drugs to make a preliminary determination on the ingredients' general safeness, among other things; (2) the FDA then reviews the active ingredients in each class of drugs based on the advisory review panel's assessment of ingredients and any public comment or new data; and (3) the publication of the drug monograph.[6] Because this system requires notice and comment rule-making, the process of amending a monograph to reflect new changes in science can take years.[7]


The new Act, which implemented provisions spearheaded by Senators John Isakson and Bob Casey from the 2018 bill,[8] will modernize the OTC drugs regulatory system, substituting an administrative order process for the rule-making process described above—which, in turn, allows new products to get to market sooner. Importantly, changing the regulatory system for OTC drugs would have quite the impact, as 60% of the medicines sold in the U.S. are OTC drugs.[9]

Some other highlights of the Act include:[10]

  • Manufacturers are able to request administrative orders and the FDA can initiate administrative orders on their own or in response to citizens' petitions.
  • FDA can take rapid action in reply to any safety issues with OTC drugs.
  • The Act will spur innovation by giving eighteen months of exclusivity for drug developers under certain circumstances.
  • FDA can collect user fees, funding the agency's mission to evaluate and monitor OTC drugs.
  • FDA would be required to evaluate the cold and cough monograph regarding children under the age of six and give an update to Congress annually.

Even though the legislation may not be enacted until the end of the current two-year Congressional session, companies with OTC products need to presently consider how the bill will affect them. For a full text of the House's Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, click here.


[1] Christine Kirk & Carter Cornick, Over-the-Counter Drug Monograph Reform Legislation in the 116th Congress, Food and Drug Law Institute Update Magazine (Apr./May 2019), https://www.fdli.org/2019/05/over-the-counter-drug-monograph-reform-legislation-in-the-116th-congress/.

[2] Norma Skolnik, Legislation to Reform the OTC Drug Monograph System: The OTC Drug Safety, Innovation, and Reform Act, EAS Consulting Group (Oct. 2018), https://easconsultinggroup.com/legislation-to-reform-the-otc-drug-monograph-system-the-otc-drug-safety-innovation-and-reform-act/.

[3] Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, H.R. 5333, 115th Cong.

[4] Kirk & Cornick, supra note 1.

[5] S. Cal., Gen. Orders, 116th Cong., 1st Sess., https://www.govinfo.gov/app/collection/ccal/116/scal/2019-06/25/daily.

[6] U.S. Dep't of Health & Human Servs., Over-the-Counter (OTC) Drug Monograph Process (2015).

[7] Michael Johnsen, OTC Monograph Reform Clears House, Senate Committees, Drug Store News (May 10, 2018), https://www.drugstorenews.com/otc/otc-monograph-reform-clears-house-senate-committees/.

[8] Kirk & Cornick, supra note 1.

[9] Johnsen, supra note 6.

[10] News Release, Isakson, Casey Introduce Bipartisan Legislation to Reform Over-the-Counter Drug Regulation (Jan. 18, 2018), https://www.isakson.senate.gov/public/index.cfm/2018/1/isakson-casey-introduce-bipartisan-legislation-to-reform-over-the-counter-drug-regulation; Kirk & Cornick, supra note 1.

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