by Dr Wayland Rushing, Ph.D.
Over the last several months we have had multiple clients come to us after being put on clinical hold for their clinical trials. The formulations are all parenterals, which utilize some kind of infusion set-up (IV bags, infusion pumps, etc). The FDA has requested determination of the extractables and leachables of the contact materials of the infusion sets.
In the past, minimal work was done on these sets and the main issue was compatibility between the drug and the materials (i.e. does the drug adhere/absorb onto the materials). Now the FDA is specifically asking for E&L evaluations of the materials, this includes going beyond the standard USP polymer characterization tests.
I have chatted with a couple of consultants on this and it is new to them as well. This seems to be something rather recent wherein the FDA is actually placing them on clinical hold until the information can be provided. As expected, this is a major concern for the companies being placed on hold, as it can be expensive and puts their development plans into a tailspin until they are able to generate the data.
Unfortunately, generating the data is not a quick and easy fix, but we have a process which seems to be appropriate. We design a study that generates the extractables data and the leachables data on the material in a side-by-side fashion. Allowing for at least a rapid generation of data to correlate to determine if any additional studies are going to be required.
