FDA official cancels pilot program for new excipients

Posted on October 11, 2021 | Through Kari oakes

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

A new U.S. Food and Drug Administration (FDA) pilot program dedicated to reviewing quality and toxicology data for new drug excipients aims to accelerate drug development by providing the agency with a more easy to qualify these ingredients.

“In some cases, the FDA may experience issues with the excipients used in a drug development application, which can affect and even delay the application,” said Karen Davis Bruno, head of the FDA, associate director of the pharmacology / toxicology in the Office of New Drugs of the Center for Drug Evaluation and Research (CDER).

Although a new excipient may offer benefits such as better bioavailability of the drug, improved absorption, or the potential for a more opioid deterrent formulation, for example, the development process may be slowed down when the FDA does not have available. no complete safety data for the new material. . The new pilot excipient review program “aims to tackle this problem head-on,” said Bruno Davis, speaking in a recent interview. published on the FDA website.

Excipients, which “may play a central role in the drug development process”, should ideally be pharmacologically inert and not interact with other ingredients of the drug; they can often have more than one use, “which can be good because it reduces the number of excipients needed and minimizes the risk of interactions between them,” noted Bruno Davis.

The pilot was developed after the agency sought input from the pharmaceutical industry in December 2019 information request. The FDA, Davis Bruno said, is aware that the complexity of including a new excipient in drug development may discourage sponsors from fully exploring how these new materials could improve public health. (RELATED: FDA’s New Pilot Excipients Candidate Program, Regulatory Focus September 08, 2021)

“When the FDA evaluates a new excipient, drug developers will be reassured that the new excipient can be used in a drug development program. It also minimizes the risk that the FDA will raise safety concerns when considering the application, ”she added.

Through the pilot, the FDA aims to achieve recognition of at least one new excipient, which means that the substance can be used in an Investigational New Drug Application (IND) “within the defined use without justification. extra, ”said Bruno Davis. The ultimate goal is for a new drug product incorporating the new excipient to be introduced to the market and for the product to meet a medical need that had not been met before.

The pilot program for new excipients is voluntary; The FDA accepts submissions in the pilot project until December 7, 2021. Only four proposals will be accepted over the 2 year period of the pilot project. In choosing the manufacturers of excipients that will be accepted in the pilot project, the FDA will take into account the potential for public health benefits of a given new excipient. Another factor, said Davis Bruno, is the substance’s potential to improve the characteristics of the drug, such as the time it takes for the drug to be absorbed, as well as the distribution, metabolism and excretion of the drug. .

Finally, the participants in the pilot project should be able to demonstrate that they can assemble and submit a complete package for the new excipient within the time frame of the pilot.

CDER Conversation: Pilot Program to Review New Excipients

New Excipient Review Pilot Webpage

© 2021 Society of Regulatory Affairs Professionals.

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