The US Food and Drug Administration (FDA) are debating the creation of a pilot programme to evaluate the toxicology and quality of novel excipients.
Currently the FDA reviews excipients used in a medicinal product as part of a marketing application to determine whether they are safe for human use. However, they have not generally been reviewing the safety of new excipients outside the context of investigational new drug applications (IND), new drug applications (NDA), or biologics license applications (BLA).
Stakeholder have pushed the FDA to establish such a programme which allows submission and review of toxicological and quality data supporting the use of novel excipients in products outside of INDs, NDAs and BLAs. This is because some novel excipient could potentially provide public health benefits, such as improved drug delivery or use in abuse-deterrent opioid formulations.
An excipient is an ingredient intentionally added to a drug or biologic, that is not intended to have any therapeutic effect, but may improve product delivery and stability characteristics. Examples include fillers, extenders, emulsifiers, preservatives and solvents.
The FDA is seeking an improved understanding of novel excipients which do not have a well-established safety history, as well as the type of safety, chemistry, manufacturing and control data that should be submitted to the FDA for evaluation. They expect that excipients which will be reviewed under this pilot will be added to the Inactive Ingredient Database once used in an approved formulations.
The FDA believes that this programme would encourage drug developers to include novel excipients with potential public health benefits in drug development, citing that many would currently avoid using them due to safety concerns raised by the FDA without the programme.
They are seeking information and comments on the proposed pilot detailed in this recent docket.