The comments from IPEC, which came during the GDUFA Reauthorization Public Meeting in June, focus on the “little incentive” excipient manufacturers currently have in developing an excipient to help pharma companies resolve formulation problems or move towards more advanced manufacturing methods.
Currently, excipients are evaluated by the FDA as part of a drug product, which means pharma companies “face uncertainty in the use of excipients in a drug product due, not to the safety or efficacy of the drug, but to the acceptability of the excipient... Additionally, the flexibility of the FDA guidance on excipient safety evaluation tends to create uncertainty about what information will be required during regulatory review.”
The new review process could be a boon for generic drug developers, IPEC says, adding that it believes that an independent excipient review process is necessary to enable excipient use in generic drug formulations and to ensure continued excipient development.
“Safety data contained in a Type IV or V DMF [drug master file] for a novel excipient (including existing excipients being used at a higher level of use or in a different route of administration and co-processed excipients) would need to be robust and meet current Agency expectations,” IPEC says.
The council notes that there “have been some steps towards independent review” but these have not changed the situation with respect to providing enough assurance on the acceptability of a novel excipient outside the drug application system. Adoption of a new review process would inspire innovation within the excipient industry and encourage pharmaceutical companies to use novel excipients resulting in important benefits for patients
IPEC in early June met with FDA toxicologists on the subject of novel excipient safety review and FDA referred IPEC to its Biomarker Qualification Program (BQP) and recommended that IPEC determine if a modified approach could be a possible model for novel excipients.
“By modifying the BQP approach in order to facilitate development and use of novel excipients, the program could provide a foundation for how IPEC-Americas might engage with FDA on modernizing novel excipient development,” IPEC says.
The group says it will continue working with GPhA (Generic Pharmaceutical Association) and the IQ Consortium to determine how best to work with the BQP, though IPEC notes that a novel excipient safety review “would need to include some type of time-line commitment similar to what is involved in GDUFA [Generic Drug User Fee Act] goal time-lines and could include a user-fee system for excipient safety review.”