In the beginning...
The Aquatic Animal Drug Approval Partnership (AADAP) Program, as it functions today, actually had its genesis in the early 1990's. In direct response to an “announcement” by the U.S. Food and Drug Administration (FDA) in 1991 that the time had finally arrived when drug and therapeutant use in aquaculture needed to be regulated, the U.S. Fish and Wildlife Service (Service), as well as many others, discontinued the use of unapproved drugs and therapeutants in fisheries programs, and engaged in the compassionate Investigational New Animal Drug (INAD) exemption process. This announcement was a “pretty hard hit” for all concerned. Prior to this development, fisheries managers’ access to needed drugs, chemicals, and therapeutants to maintain fish health and manage production programs was limited only by one’s imagination and/or access at a chemical supply company or the local Ranch N’ Home store. This situation was further exacerbated by the fact that only three therapeutants and a single anesthetic were actually approved for use in aquatic species, and use of these compounds was severely restricted by species, water temperature, and life-stage. Although compassionate INAD exemptions did allow for the continued use of certain unapproved drugs in an approved-manner (i.e., under strict FDA guidelines), fish culture had changed forever.
The National INAD Office...
In 1994 the Service officially established the National INAD Office (NIO) in Bozeman, Montana USA. The sole responsibility of the NIO was to establish and administer compassionate INADs for use by Service facilities. For all practical purposes, this meant little more than establishing and maintaining a “paperwork trail” that verified compliance of Service facilities with INAD drug use requirements. Although this effort was “no small task” and did include the submission of all INAD-generated data to FDA, it soon became apparent that while INADs by themselves were a good interim measure to ensure access to needed drugs, they were not a valid long-term solution to fulfill aquatic species’ drug needs. What was really needed were bona fide new animal drug approvals or applications (NADAs) for aquatic species. The need for NADAs was further clarified when it was realized by the NIO (circa 1996) that compassionate INADs would only receive renewed FDA-authorization if actual progress towards an NADA was demonstrated. Although it is more than a bit of an oversimplification, NADAs require the submission of high quality (i.e., pivotal) data to meet FDA-requirements for the completion of the five major NADA technical sections which include: 1) Good Manufacturing Procedures; 2) human food safety; 3) efficacy; 4) target animal safety; and 5) environmental safety. Although NIO resources were limited, the program was expanded in 1996 to include a research program designed to generate pivotal efficacy data in support of NADAs for aquatic species. Pivotal efficacy data are used to demonstrate that a drug is indeed efficacious with respect to its proposed label claim.
In 1997, the NIO’s new research program was expanded to also include the conduct of pivotal target animal safety studies. Target animal safety studies are used to demonstrate that the proposed label claim use-pattern of a specific drug is in fact safe to the animals being treated, i.e., the target animals. Given that FDA requires target animal safety studies be conducted according to Good Laboratory Practices (GLP) standards, the NIO by necessity established a GLP-compliant research program at that time as well.
In 1998, the NIO 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 a recent FDA Workload Plan that strongly encouraged the utilization of large, consolidated INADs by the aquaculture community. Although the NIP was initially restricted to participation by state, tribal and private aquaculture agencies/facilities located in six northwestern states, the program was expanded in 1999 to allow participation by agencies/facilities in all 50 states. The NIP has been a resounding success and has provided needed access to drugs and therapeutants to fisheries management programs throughout the United States.
Throughout the NIO’s relatively rapid evolution from a somewhat narrow-focused, Service INAD program to a much broader program of national scope focused on the development of both INADs and NADAs for the entire aquaculture industry, the NIO has been an active participant in the International Association of Fish and Wildlife Agencies (currently called the Association of Fish and Wildlife Agencies) Drug Approval Project (IAFWA Project). The IAFWA Project was a Federal - State partnership project that was established in 1994 to coordinate, fund, and conduct research directed towards NADAs for eight priority aquaculture drugs. IAFWA Project participants included the US Geological Survey (USGS), US Fish & Wildlife Service (FWS), US Department of Agriculture (USDA), and the IAFWA, on behalf of 38 participating states. Based on the enormity and complexity of the aquatic species drug approval process, it was readily apparent to all participants that only by engaging in such a coordinated, concerted, partnership effort would the opportunity for success exist. The IAFWA Project was initially established as a 5-year project (thru September 1999), and was subsequently extended for an additional 3 years (thru September 2002).
During its 8 years of existence, the IAFWA Project was instrumental in many accomplishments, including significant progress towards advancing 13 specific label claims for six drugs to near completion. However, as the termination of the IAFWA Project approached and participation by some entities appeared to wane, it became very clear to the Service that some agency/organization would need to “step-up” and assume a greater leadership role. With strong support from many partners the Service, via the establishment of the AADAP Program, agreed to help fill this important role.
The AADAP Program...
The AADAP Program was officially established within the Service’s National Fish Hatchery System in January 2003 with the strong support of then Service Director Steve Williams. The stated goal of AADAP is to ensure continued progress towards obtaining FDA-approved and EPA-compliant new animal drugs for use in Federal, State, Tribal and private aquaculture programs throughout the United States. As its name implies, the AADAP is a broad, partner-based program of national scope. Utilizing increased program funding and staff, the AADAP incorporates and expands on all existing INAD and NADA activities of the NIO, with specific added responsibility for NADA management and information transfer and dissemination. Although the NIO remains in existence, it is now a part of the AADAP Program, both of which are located in Bozeman, Montana USA. In somewhat generic terms, the AADAP will help to lead a coordinated national effort to generate data, analyze results, compile final study reports, disseminate information and data, and manage all other aspects of requisite data submissions to FDA in support of new animal drug approvals for aquatic species. The AADAP builds on long-standing partnerships between the Service’s NIO and over 50 Federal, State, Tribal and/or private agencies or organizations. The AADAP, in its role of obtaining new approved drugs and chemicals for aquatic species, is integral to the Service’s successful stewardship of our natural resources for the enjoyment of all Americans.