FDA Debates Creating Pilot to Evaluate Novel Excipients

Regulatory NewsRegulatory News | 04 December 2019 |  By 

The US Food and Drug Administration (FDA) on Wednesday sought comments on whether it should run a voluntary pilot program to evaluate the toxicology and quality of novel excipients.

While the agency does currently review new excipients as part of an investigational new drug application (IND) or a marketing application (NDA or BLA), FDA explains how certain novel excipients may provide public health benefits, such as improved drug delivery or utility in abuse-deterrent opioid formulations.

The term "excipient" is defined by FDA as any ingredient intentionally added to a drug or biologic that is not intended to have a therapeutic effect but may improve product delivery. Examples of excipients include fillers, extenders, diluents, wetting agents, solvents, emulsifiers, preservatives, flavors, absorption enhancers, sustained-release matrices and coloring agents.

As far as how the pilot would work, the agency notes: “FDA recognition of a novel excipient would mean that, based on a review of safety, manufacturing, and compositional information, FDA has determined that the proposed context of use (e.g., acute or chronic exposure by specified route(s) of administration up to specified amounts) is expected to be safe. This determination would obviate the need for FDA review of the excipient in the context of an IND if its use in the investigational product is consistent with the recognized context of use,” the agency explains.

FDA also says it expects that excipients reviewed under this pilot program, after they are used in approved formulations, would be listed in the inactive ingredient database. Drugmakers and industry groups recently called on FDA to expand and clarify its recent draft guidance on how to use its inactive ingredient database.

As far as comments, FDA says it’s seeking a better understanding on the types of novel excipients that do not have a well-established history of safe use in food but might have public health benefits, as well as what safety data and certain chemistry, manufacturing, and controls information should be submitted to FDA.

“Are there adequate incentives for excipient manufacturers to engage in this process, particularly in situations in which multiple manufacturers may be undertaking to develop closely related novel excipients? If not, what incentives would encourage excipient manufacturers to engage in this process?” the agency questions.

Federal Register


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