PharmTech: What can you tell us about the panel of experts involved in this review program?
Schoneker: IPEC has a new excipient evaluation procedure that we put together that allows a sponsor company to have an expert
panel. The panel reviews the public and private information and develops an expert report. This expert report can be either
given to a drug company in support of the use of a new excipient or a higher level of use of an existing excipient, which
can be provided in the NDA or it can be incorporated into a company's drug master file (DMF). If the company felt the data,
for whatever reason, was confidential and they couldn't supply it to their customer, then they could put it into a DMF with
a reference to the customer who could then have FDA reference that data as part of its review. There are a couple of different
mechanisms. This is a system we are working through now and starting to get usage on.
To make it even more beneficial, we are very fortunate to have the help of a key toxicologist, Dr. Robert Osterberg, who directed
a group at FDA's CDER that reviewed the safety of new excipients or new excipient types at the agency. Fortunately, just as
we were getting ready to roll this program out, Dr. Osterburg retired and went to work for a consulting company and we asked
him to coordinate these panels.
There has been a material that has already gone through this system, and FDA said it would provide us with some feedback about
the kind of report that was put together so that we would have an idea about the agency's expectations. We've done that and
information about that project was provided at our IPEC conference (held in October).
Online references For more information regarding IPEC's safety evaluation process, visit the following resources: