INAD Program
Background
Prior to 1998, all compassionate Investigational New Animal Drug (INAD) exemptions held by the U.S. Fish & Wildlife Service (Service) were restricted to use by Service facilities only. In 1998, the Service’s National INAD Office in Bozeman, MT established the fledgling National INAD Program (NIP) that, for the first time, allowed participation by non-Service entities on Service-held compassionate INADs. Not only was the NIP the “right thing” for the Service to initiate, it was also supported by an FDA Workload Plan that strongly encouraged the utilization of large, consolidated INADs by the aquaculture community. Additional impetus was provided by the fact that the Western Regional INAD Project (WRIP, sponsored by the Columbia Basin Fish and Wildlife Authority) that had been operational since 1994 and had provided for the INAD-needs of state, tribal, and private aquaculture in six northwestern states was scheduled for termination. INAD-wise, this pending circumstance was going to leave many of these folks in dire straits.
When the NIP was initially established, participation was restricted to state, tribal, and private aquaculture agencies/facilities that had previously been a part of the WRIP (i.e., folks in the states of Alaska, California, Idaho, Montana, Oregon, and Washington). In 1999, the NIP was expanded to allow participation by similar agencies/facilities in all 50 states. Over time participation in the NIP has fluctuated along with the ever-changing needs of fisheries management. However, cumulative participation in the program has steadily grown. From a Service perspective, the NIP has been a resounding success and has provided needed access to drugs and therapeutants to fisheries management programs throughout the United States. Participant response with respect to the NIP, including frequent comment from the FDA, has been similarly positive. It is also important that through the NIP we (i.e., aquaculture) have been able to generate a wealth of important ancillary efficacy and target animal safety data that will ultimately be useful in supporting broad new animal drug approvals for a variety of specific fish drugs/therapeutants.
The NIP is operated on a cost-reimbursable basis with an annual cost of $700.00 per INAD per facility per year. All money collected is directed towards funding the operational needs of this important program. Participation also requires that all participating agencies/organizations sign a Cooperative Agreement with the Service. This Cooperative Agreement establishes the obligations to be met and the procedures to be followed by the Service and all Cooperators to allow the use of specific drugs and chemicals under the compassionate INAD process as set forth by the FDA.
If you have any specific questions regarding the NIP, or should wish to sign-up for participation in NIP, please contact Bonnie Johnson.
