Over-the-Counter (OTC) drug monographs represent current regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. These standards provide the marketing conditions for some OTC drug products including the active ingredients, labeling, and other general requirement
in the US, OTC drug medicines making up around 60% of all medicines (Prescription (Rx) and Non-Prescription). Developed in 1972, the OTC monograph system has been instrumental in lowering the cost of entry and standardizing requirements across different formulations, however progress in moving forward in adding and amending monographs has not kept up with expectations of the FDA or industry mostly due to an outdated, multi-layered rulemaking process. This caused a large OTC Monograph backlog in which product labels could take years to update.
As a response to this, included in the CARES Act, (implemented into law on March 27, 2020) is a major piece of federal legislation that amends the FD&C Act to modernize the OTC drug review and OTC monograph drug development process, essentially by removing the multi-step rulemaking with new administrative order process, among other changes.
This revision gives FDA the authority to issue an administrative order that adds, removes or changes Generally Recognized as Safe and Effective (GRASE) conditions for an OTC drug monograph. In addition, the act establishes an expedited process to address safety issues. Another notable improvement is that either the industry or the FDA can initiate the administrative order process, allowing for both sides to make suggestions to improve.
In addition to an overhaul of the process and in order to improve efficiency and scale resources, the CARES Act provides FDA with the authority to collect user fees dedicated to OTC monograph drug activities. These fees include facility fees and OTC Monograph Order Request (OMOR) fees. FDA also released Over-the-Counter Monograph User Fee (OMUFA)
Program Performance Goals and Procedures document, which specifies FDA and industry mutually agreed upon timelines for turnaround time, Public comment period, issuances of orders for OTC Monograph Order Requests (OMORS).
These OMORs are data packages with requests to change a monograph. The two-tier system is separated into essentially Tier One, which is for adding new ingredients, indications, combination, route of administration, dose or test methods to a monograph, while Tier two is about reordering information, nomenclature changes, or other more minor adjustments. The fees for a Tier One submission are set at $500,000 and a Tier two request is set at $100,000. For OMUFA purposes, industry-paid fees will help fund a portion of FDA’s regulatory activities for OTC monograph drugs and FDA agreed to adhere to performance goals, including to review submissions within specific time frames. A table summarizing the established timelines by FDA is detailed below:
Resulting from this OTC drug monograph reform, there are some additional considerations. First, it is important to familiarize yourself with the new law, keeping in mind the current status of OTC monograph drugs that you have interest in. You can see the law in its entirety here.
The next step would be to 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.
Currently, active ingredients are classified in 3 categories:
- Category I: generally recognized as safe and effective for the claimed therapeutic indication;
- Category II: not generally recognized as safe and effective or unacceptable indications;
- Category III: insufficient data available to permit final classification
Additionally, become familiar with the current regulatory status of active 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.
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- Over-The-Counter Monograph User Fee Program (OMUFA) U.S. Food and Drug Administration. Last Updated June 4, 2020.