OTC monograph reform is now law: What’s next?

Feature ArticlesFeature Articles | 07 April 2020 | Citation

This article discusses the impact of over-the-counter (OTC) monograph reform, part of the recently passed Coronavirus Aid, Relief and Economic Security (CARES) Act.

Regulators and public health stakeholders have been championing OTC monograph reform for more than five years. Then, in what seems like a blink of any eye, it is now law, passed by Congress and signed by the President on 27 March 2020 as part of the CARES Act for pandemic relief. The new law reflects the major reforms sought by the US Food and Drug Administration (FDA) and industry and, once implemented, will deliver a modernized regulatory system covering about 60% of OTC medicines that is more responsive and more transparent than the prior system while continuing to ensure these medicines are safe for consumers.
The reform law provides more than $110 million over five years of OTC monograph user fee authorization for FDA to significantly increase capacity and expertise in the Office of Nonprescription Drug Products. With this increased funding, FDA’s capacity to work on OTC monograph ingredients will more than triple over the next five years.
The updated system removes barriers to improve speed and responsiveness. In particular, administrative orders replace rulemaking, allowing for faster decisions while maintaining high standards. This is because the administrative order process can be run directly through the Center for Drug Evaluation and Research (CDER), rather than going through the full clearance process required for rulemaking. Because many of the clearance processes have been removed, the law also includes a dispute resolution and hearing provision to assure due process. An expedited process, known as an interim final order, is available in the event of a serious emerging safety issue.
The prior OTC monograph system had become gridlocked. With reform, unfinished monographs, approximately 20% of the total, that have languished for years will be completed based on a review of available data and under a process driven by a dashboard through which FDA alerts stakeholders to its three-year priorities. Additionally, new technology and new ingredients can be added to monographs via the administrative order process. Long viewed as a system that did not encourage innovation, the reformed system encourages innovation by providing a pathway to amend monographs and potential incentives to reward investment in new products.
Now that monograph reform is law, what do we expect next? We anticipate an early focus by FDA on consumer safety. Under the former rulemaking system, FDA found it very cumbersome to require labeling changes due to safety issues. Instead, they increasingly used non-rulemaking approaches to effect safety labeling changes and notify consumers and healthcare professionals of safety concerns. These approaches were not optimal and did not result in changing the appropriate monograph. Under OTC monograph reform, FDA will be able to issue administrative orders to require these changes, ensuring uniformity in labeling.
Finally, the law amends the Sunscreen Innovation Act (SIA). Pending sunscreen ingredients that were filed with FDA under a time and extent application can elect to remain in the SIA or may change to the reformed OTC monograph system. The SIA now will sunset at the end of fiscal year 2022.

Although the new system is effective as of 27 March, as with any completely new system, there will be a start-up period. The current COVID-19 public health emergency further stretches existing resources at FDA. The following next steps are recommended for regulatory professionals supporting OTC monograph products:
  1. Familiarize yourself with the law and accompanying goals letter to understand what changes will be coming for OTC monograph products. The Consumer Healthcare Products Association (CHPA) is offering training webinars and a resource page on its website. A series of guidance documents and proposed administrative orders will be issued from FDA. Some of the topics are meetings, content and format for submissions, consolidated proceedings, electronic submissions, CDER dispute resolution, oral solid dosage form order and draft guidance. There will be a new website where information will be posted and a new portal for the submission and comment processes.
  2. Familiarize yourself with the current regulatory status of ingredients in your OTC monograph products. Some ingredients, such as those with Category I status in a tentative final monograph, become final under the law, thus providing more certainty about generally recognized as safe and effective (GRASE) status. Others, such as those with Category II status, will now have a timeline for either market withdrawal or contacting FDA to discuss alternate plans. Still others, such as those with Category III status, will need to resubmit existing data or generate additional data when FDA issues a proposed administrative order to finalize their GRASE status. It is expected that in some cases, industry may work together to assemble data packages or to conduct additional research.
  3. Review your facility registrations. Funding for OTC monograph reform comes primarily from fees paid based on facilities that manufacture or process OTC monograph drug products in finished dosage form. FDA will soon publish user fees for Year 1 of this program, and the fees will be due the later of July 2020, or 45 days after FDA published a notice of the fee amount.
  4. Get or stay engaged in the broader community. There will likely be opportunities for companies to work together to amend monographs in support of safety or innovation.
Looking ahead, everyone should be prepared for a faster-moving, more nimble system requiring responsiveness and excellence in regulatory affairs as the industry works with FDA to finalize unfinished monographs and identifies new innovations. It’s exciting to look forward to these activities and working together to further public health under a modernized regulatory system.
About the Authors
Barbara Kochanowski, PhD, is senior vice president of regulatory and scientific affairs at the Consumer Healthcare Products Association (CHPA). Prior to joining CHPA in 2009, Kochanowski worked for more than 23 years in research and development at the Procter and Gamble Company (P&G), before retiring in December 2008 as director of global personal health care, oral care and feminine care product safety and regulatory affairs and corporate microbiology. She is experienced in pharmaceutical, medical device and dietary supplement regulatory affairs; Rx-to-OTC switch, product safety, clinical research and pharmacovigilance. While at P&G, Kochanowski was very active in CHPA activities, serving as chair of the scientific affairs committee from 2007-2009, which brought with it an ex officio position on the CHPA board of directors for the same period. Kochanowski is a member of the American Society of Nutrition. She also serves on the board of directors of the American Foundation for Pharmaceutical Education. She is the past president of the Penn State Nutrition and Dietetics Alumni Society. She can be reached at bkochanowski@chpa.org.
David C. Spangler is senior vice president at CHPA and leads the association’s team of eight across legal, government affairs and policy functions with specific expertise in regulatory matters. Spangler joined CHPA in 1984 as a legislative analyst. He subsequently served in a number of roles for the association in the president's office, project management, international affairs, and, after completing law school in 1995, the association's legal department. Spangler was named a vice president in 1997, and a senior vice president in 2006. His responsibilities were expanded to his current role in 2019. Spangler is a member of the District of Columbia Bar as well as the American Society of Association Executives. He authored the chapter on OTC medicines in "Modern Pharmaceutical Industry: A Primer" and has served on a range of committees and working groups for the Food and Drug Law Institute and the Global Self-Care Federation. Spangler earned his Certificate in Organizational Management in 1991 from the US Chamber of Commerce's Institute for Organization Management. He earned his JD from George Washington University National Law Center. He can be reached at dspangler@chpa.org.
Cite as: Kochanowski B and Spangler D C. “OTC Monograph Reform is Now Law: What’s Next?” Regulatory Focus. April 2020. Regulatory Affairs Professionals Society.


© 2023 Regulatory Affairs Professionals Society.

Tags: OTC drugs, US

Discover more of what matters to you

No taxonomy