How does the FDA approve new pills like the Perrigo Opill for over the counter (OTC) use?

The FDA has approved the first OTC birth control pill for the US market, and the Perrigo Opill is now slated to be available in early 2024. This led the curious team at Emme to take a look at the FDA process for approving over the counter (OTC) pills. The process for the U.S. Food and Drug Administration (FDA) to approve over-the-counter (OTC) pills involves a specific regulatory pathway designed to ensure their safety and effectiveness for consumer use. Here's an overview of the FDA's OTC drug approval process:

1. For OTC drugs the FDA uses a monograph system: Unlike prescription drugs, which go through a rigorous individual review process, most OTC drugs are governed by the FDA's OTC drug monograph system. The monograph establishes specific conditions, ingredients, formulations, labeling, and usage instructions for different categories of OTC drugs.
2. Tentative final monograph: The FDA publishes a proposed monograph for each category of OTC drugs, outlining acceptable ingredients, doses, and labeling requirements. This serves as a guideline for manufacturers to follow when developing their OTC products.
3. Generally Recognized as Safe and Effective (GRASE): The FDA determines whether an ingredient or combination of ingredients is GRASE, meaning it is generally recognized as safe and effective for its intended purpose. This evaluation considers scientific data, expert opinions, and public input.
4. There is an OTC drug review: If an ingredient or formulation is not covered by an existing monograph, manufacturers can submit a New Drug Application (NDA) to the FDA, seeking approval for their OTC drug. The FDA then reviews the safety and effectiveness data provided by the manufacturer.
5. The FDA uses advisory panels: In some cases, the FDA may convene advisory panels composed of experts from relevant fields to evaluate the safety and efficacy of specific OTC drug ingredients or products. These advisory panels provide recommendations to the FDA based on their expert assessment.
6. Labeling requirements: The FDA sets specific labeling requirements for OTC drugs, including instructions for use, warnings, precautions, and information about potential side effects. The labeling should be clear and easy for consumers to understand.
7. Ongoing monitoring: Once an OTC drug is on the market, the FDA continues to monitor its safety through post-marketing surveillance. Reports of adverse events or emerging safety concerns can lead to product recalls or label revisions.

It's important to note that while the FDA oversees the approval and regulation of OTC drugs, consumers should always follow the instructions and consult healthcare professionals if they have any concerns or questions about using OTC medications.