FDA official breaks down novel excipient pilot program

Regulatory NewsRegulatory News | 11 October 2021 |  By 

Karen Davis Bruno, Office of New Drugs, CDER, FDA

A new pilot program from the US Food and Drug Administration (FDA) dedicated to reviewing quality and toxicology data for novel drug excipients is aimed at speeding drug development by providing an easier pathway for the agency to qualify these ingredients.
“In some cases, FDA may find issues with the excipients used in a drug development application, which can affect and even delay the application,” explained FDA official Karen Davis Bruno, associate director of pharmacology/toxicology in the Office of New Drugs at the Center for Drug Evaluation and Research (CDER).
Although a new excipient might offer advantages such as better drug bioavailability, enhanced absorption, or the potential for a more abuse-deterrent formulation for opioids, for example, the development process can be slowed when FDA does not have full safety data for the novel material. The novel excipient review pilot program “aims to address this problem head-on,” said Davis Bruno, speaking in a recent interview published on FDA’s website.
Excipients, which “can play a central role in the drug development process,” should ideally be inert pharmacologically and not interact with other drug ingredients; they may often 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,” noted Davis Bruno.
The pilot was developed after the agency solicited input from the pharmaceutical industry in a December 2019 request for information. FDA, said Davis Bruno, has been aware that the complexities of including a novel excipient in drug development may be a disincentive for sponsors to explore fully how these novel materials could improve public health. (RELATED: FDA’s novel excipient pilot program opens for candidates, Regulatory Focus 08 September 2021)
“When FDA evaluates a novel excipient, drug developers will be reassured that the novel excipient can be used in a drug development program. This also minimizes the risk that FDA would raise safety concerns during application review,” she added.
Through the pilot, FDA aims to achieve recognition of at least one novel excipient, meaning that the substance can be used in an investigational new drug (IND) application “within the defined use without additional justification,” said Davis Bruno. The ultimate goal is for a new drug product that incorporates the novel excipient to be introduced into the market, and that the product will meet a medical need that had previously been unmet.
The novel excipient pilot program is voluntary; FDA is accepting submissions into the pilot until 7 December 2021. Just four proposals will be accepted over the pilot’s 2-year span. In choosing which excipient manufacturers will be accepted into the pilot, FDA will give weight to the potential for public health benefit for a given novel excipient. Another factor, said Davis Bruno, is the potential the substance has to improve such drug characteristics as how long it takes for the drug to be absorbed, as well as drug distribution, metabolism and excretion.
Finally, pilot participants should be able to demonstrate that they can pull together and submit a complete package for the novel excipient within the timeframe of the pilot.
CDER Conversation: Novel Excipient Review Pilot Program

Novel Excipient Review Pilot Program web page


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