In the US, drugs may either be prescription drugs, requiring a prescription by an authorized health care provider, or they may be over-the-counter (OTC) drugs, which are purchased directly by a consumer without a prescription. Each drug category has a different path to market, and the process demonstrating the safety and efficacy differs between prescription drugs and OTC drugs.
Prescription drugs require submission of a new drug application (NDA) to the FDA for approval for the safety and efficacy of the drug for its intended use/s, prior to going to market. On the other hand, for the most part, OTC drugs do not require approval or a licence. Instead, OTCs come to the market via the OTC monograph pathway. In a number of cases, some drugs do not fully align with an OTC parameter and are required to receive approval via the NDA pathway prior to marketing the drug. Importantly, OTC drugs are considered by the FDA to be safe and effective for consumer use as per the label directions and warnings for the intended use and are specified for medical conditions that consumers may self-diagnose. Due to the self-diagnosis of such drugs, OTCs have a higher margin of safety, compared to a prescription or new drug. OTC monographs cover ~ 800 active ingredients for over 1400 uses and authorizing over 100,000 drugs. There have recently been some significant changes to this pathway, which originally established in the 1970s by the US FDA with the OTC review process.
On March 27th 2020, the President signed the Coronavirus Aid, Relief and Economic Security (CARES) Act into law (HR 748).1 The CARES Act contains important legislative initiatives for Over-The-Counter (OTC) Monograph Reform to modernize the way in which OTC monograph drugs are regulated in the US. This reform replaces the rulemaking with new administrative orders, improves efficiency, timelines and predictability of the OTC monograph process, and expeditiously addresses safety, and establishes user fees to implement this new process.
The main changes to the OTC monograph reform under the initiatives are outlined here:
A few processes will remain the same for the OTC monograph reform, namely:
Over the coming months, the FDA will be providing more updates on the OTC Monograph Reform. Various guidance resources will be provided under this new process, and the timelines for when to anticipate guidelines will be laid out in the goals document that serve to communicate performance goals.
For assistance in confirming that your product meets the FDA requirements set forth under the OTC monograph, contact dicentra today.