By Barbara A. Kochanowski, senior vice president of regulatory and scientific affairs
Consumer Healthcare Products Association
August 1, 2017
For the past three years, the regulated industry has been working with the U.S. Food and Drug Administration (FDA) to reform the OTC Monograph System, the regulatory framework under which most over-the-counter (OTC) products are regulated. Why? Because the once highly effective system is no longer functioning to serve consumers, the industry, or the regulators.
The OTC Monograph System was put in place in the early 1970s. In the early years, it met its goal to efficiently organize thousands of products that had been marketed with little oversight. Expert panels determined which ingredients, including their doses and claims, would be designated Generally Recognized as Safe and Effective, or GRASE. For decades, FDA took recommendations from the panels, proposed regulations for categories of ingredients, reviewed public comments, and finalized category monographs. The monographs provided a framework for manufacturers to formulate, label, and market products containing OTC active ingredients without FDA pre-approval. This system, which is unique to the United States, served the public health well for over 40 years. If issues occurred, FDA used the rulemaking process to amend monographs, for example, by adding new warnings or changing dosing.
Over the past dozen or more years, the OTC Monograph System has slowed, driven by many factors, including reduced FDA resources and overall slowing of government rulemaking. Even in cases where new safety warnings are needed, FDA has been severely challenged to issue amendments. At first, industry encouraged FDA to work harder, but it became clear that changes were needed. In addition, industry has been frustrated by the stagnant state of the system, which makes innovation difficult without the costly process of filing a new drug application. Discussions between FDA and industry have resulted in a proposal for reform that is currently in the legislative process. While passage is uncertain, the reforms represent a tremendous opportunity to improve public health and open opportunities for innovation.
As currently envisioned, OTC Monograph System reforms do not include new drug application (NDA) or homeopathic products, neither of which are part of the system today. The overall goal is to preserve those elements of the system that still function while modernizing the system to be responsive to today’s needs. Decision making will be faster by replacing rulemaking with an administrative order process that includes public comment, but leaves decision making within FDA Center for Drug Evaluation and Research. For immediate safety needs, there will be an accelerated path of “interim final order.” If legislation passes, ingredients currently Category 1 in Tentative Final Monographs will be deemed GRASE. A dashboard issued by FDA will preview the monographs that will be a focus over the next few years, so industry can assemble any data needed to complete ingredient reviews. Closed meetings between industry and FDA will enable meaningful discussions about data requirements and research protocols. A novel dispute resolution process will enable appeals of decisions.
The system changes highlighted above come at a cost to be funded jointly by industry and FDA. FDA has agreed to increase base appropriations for OTC Monograph work while user fees from the regulated industry will significantly increase FDA resources to complete unfinished monographs, expeditiously address safety issues, and support innovation. The program is modest compared to other user fee programs and simple in design to keep administrative costs low. Fees will come from a charge to those facilities manufacturing OTC Monograph products. FDA will discuss user fees in more detail in a public webinar on Aug. 23, 2017.
Efforts are underway to enact these reforms via legislation, which are broadly supported by FDA, industry, and key stakeholder groups.
The Consumer Healthcare Products Association (CHPA) is a 136-year-old national trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements. CHPA is committed to empowering consumer self-care by preserving and expanding choice and availability of consumer healthcare products. CHPA is an Affiliate member of AAHP.