FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review. The pilot program offers a new pathway for drug manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) before the excipients are used in drug formulations.
On December 5, 2019, a Request for Information (RFI) was posted in the Federal RegisterExternal Link Disclaimer to gather input from industry to evaluate interest in developing a pilot program and to identify potential challenges. FDA considered this public feedback in developing this pilot.
In this CDER Conversation, Karen Davis Bruno, PhD, OND Associate Director of Pharmacology/Toxicology, speaks about the Novel Excipient Review Pilot Program.
Karen, can you begin by explaining what a novel excipient is?
Certainly. Excipients are inactive ingredients that FDA reviews as a component of a finished drug in a new drug application or a generic drug application.
An excipient is any ingredient or substance intentionally added to a drug that is not part of the active substance. These inactive ingredients can work to stabilize medications and help the body absorb the active ingredients. Excipients can play a central role in the drug development process, in the formulation of safe, balanced, and reliable dosage forms, drug performance, and how the drugs are taken or given.
Ideally, an excipient is pharmacologically inactive, non-toxic, and does not interact with the active ingredients or other excipients. Many excipients have more than one use, which can be good because this reduces the number of excipients needed and minimizes the risk of interactions among them.
Examples of excipients are diluents to increase the weight or volume of tablets, flavoring agents in chewable or disintegrating tablets, a coating solution for bad-smelling tablets, sustained-release excipients, and coloring agents. Excipients can also be used to improve drug safety, help maintain drug integrity during storage, and move the drug to the part of the body where it is needed. Other benefits of excipients include facilitating opioid abuse-deterrent formulations or promoting the development of new therapies for serious life-threatening diseases
And for the purposes of this pilot program, a novel excipient is any excipient that is not fully supported by existing safety data. For this pilot program, we will consider novel excipients that have not been previously used in FDA-approved drugs and that do not have established use in food.
What exactly is the Novel Excipient Review Pilot Program and what does it do?
Although excipients can play an important role in helping patients tolerate medications or transporting the drug within the body, excipients can also carry risks. For example, some excipients can include materials that trigger allergies. For that reason, FDA evaluates excipients for safety and stability. In some cases, FDA may find issues with the excipients used in a drug development application, which can affect and even delay the application.
The pilot aims to address this problem head-on. With this pilot program, FDA will offer a pathway to evaluate excipients that could provide important public health benefits, such as increased drug bioavailability or absorption, more comfortable drug administration, new abuse-deterrent opioid formulations, new routes of drug delivery, and the facilitation of new technologies.
The intention of the pilot is to evaluate novel excipients for specific contexts of use that address drug development needs. We’re hopeful the pilot will encourage innovation through incentivizing use of novel excipients in drug development by demonstrati...
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