The cooperative effort between FDA’s Inactive Ingredients Database (IID) Working Group and the International Pharmaceutical Excipients Council (IPEC) to improve the IID’s content and functionality is beginning to bear fruit and will gain further momentum from the extra resources that will become available to the Office of Generic Drugs (OGD) to support projects that meet the Generic Drug User Fee Act (GDUFA) goals of creating a more efficient review process.
Facets of the IID initiative that are now gelling include:
● a frequently asked questions (FAQ) that will help clarify the database’s use and a number of areas that have created confusion within the industry regarding FDA’s expectations for how IID references are to be made and supported.
● a standardized approach for supplying information to streamline the submission and review processes
● posting historical files on a quarterly basis to allow searches for name or level changes that occurred.
● a review of priority excipient families, including hypromellose, polyethylene oxides, silicone, and carbomers, and
● a prototype database that explores how data could be more effectively added and accessed.
Discussions are also advancing regarding:
● systems for controlling changes made to the IID and communicating them externally and internally
● adding and searching synonyms and trade names, and
● refining the excipient family approach to facilitate common pharm-tox evaluations.
In the longer term, the OGD/IPEC dialogue on the IID, in conjunction with the ongoing effort under GDUFA to create a more efficient drug master file (DMF) system, could open the door for developing a less-cumbersome clearance process for novel excipients – an objective of IPEC’s since its formation two decades ago.
Advancing Communications Include FAQ
At the GPhA Fall Technical Conference in late October in Bethesda, Maryland, OGD Chemistry Division Director Robert Iser reviewed the progress that the OGD working group (WG) and IPEC have made in upgrading the IID and the communication process that supports it.
“I think we have accomplished a lot of good things in terms of working with not only the IPEC working group but also internally,” Iser said.
In an interview with IPQ conducted following Iser’s presentation, Colorcon Global Regulatory Affairs Director David Schoneker, who has been a key player on the IPEC team interacting with OGD’s IID WG, provided further insights on the IPEC/OGD collaboration.
Schoneker shed additional light, in particular, on the discussions underway to simplify the excipient pharm-tox evaluation, submission and review processes when the use of an excipient may not be covered by the levels that already exist in the IID.
The collaboration “has been one of the most valuable interactions that IPEC has ever had with the agency,” he commented, characterizing the discussions as “very open and productive.”
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