As a private aquaculture producer you have an important opportunity to participate in a public-private sector partnership by providing essential assistance to gain approvals of several high priority drugs for use in aquaculture.  Millions of dollars in public funds have been spent to complete much of the data required for numerous drug approvals.  Now data are required from private producers that will demonstrate that a particular drug is effective under commercial production conditions to control or prevent certain diseases or mortalities.  Two kinds of efficacy studies are needed: well controlled  (pivotal) and corroborating (supporting).  The supporting studies can be conducted at any commercial production facility and that is why producers can provide such critical support.  These efficacy studies are fairly simple--just a little more record keeping following a prescribed protocol (recommended procedures) beyond your normal activities that proves that the drug you are using is effective in controlling or preventing a disease.

Considerable scientific data are needed to prove that a drug is safe for humans and the environment and that a drug is effective for an intended purpose before the FDA Center for Veterinary Medicine (CVM) can approve a drug for aquaculture use.  All the data, other than supporting efficacy data, have been or are being generated at facilities that meet stricter data collection requirements.  In many cases, these facilities cannot generate the supporting efficacy data that producers can provide during normal production activities.

The following analogy with this year's Super Bowl was developed to highlight our accomplishments and the critical need for your assistance to WIN the big game.  Without your help, we may not be able to obtain all the desired drug approvals.  You can directly benefit yourself and the aquaculture industry by becoming an active player in the game to complete AThe Shortest Yard@ that will lead to approvals for the following high priority drugs.  Join the team and let the game begin!

 APPROVAL SUPER BOWL GAME

Only efficacy studies (AThe Shortest Yard@) remain to complete all the critical first downs (data submissions) needed to score many touchdowns (drug approvals) and a win in the Approval Super Bowl game for the Federal-State Aquaculture Drug Approval Partnership (U.S. Aquaculture Team).  These drug approvals will benefit the whole U.S. aquaculture community.  However, if these efficacy studies are not gained to support approvals, we will be like the Tennessee Titans in Super Bowl 2000 and fall AThe Longest Yard@ short of the goal line and our long-fought victory.

 Unlike annual football Super Bowl games, this Approval Super Bowl game is the only opportunity of gaining legal use of high priority drugs for aquaculture.  Without a few more first downs from efficacy studies, we will not gain approvals (touchdowns) for label claims for different drugs even though the other first downs (environmental safety, residue chemistry, and target animal safety) moved us near the goal line and would have covered all the possible label claims.

 THE FIRST THREE QUARTERS OF THE DRUG APPROVAL SUPER BOWL GAME

During the first three quarters of the Approval Super Bowl game, the combined efforts of the U.S. Aquaculture Team (public and private aquaculture entities along with the pharmaceutical and chemical sponsors) has either scored or reached the goal line for the following drugs: 

Table 1.           All efficacy studies needed for the indicated label claims are complete and approvals (touchdowns) have been obtained or are pending  

 The U.S. Aquaculture Team has two touchdowns (approvals) and has moved three drugs to the goal line in terms of required efficacy studies.  Several label claims do not require any more supporting data but other data are still needed to complete the data packages for approvals.  Supporting efficacy data have been accepted for formalin to control or prevent fungi on salmonids and for oxytetracycline to control Aeromonas sp. in coolwater fish, but pivotal efficacy studies are still needed.  Supporting data are available in the literature for both copper sulfate and potassium permanganate to control or prevent fungi on fish and control external flavobacteriosis and external parasites.  All efficacy data on chloramine-T to control external bacterial gill disease on salmonids in freshwater are complete but data other than efficacy needed for approval must still be generated.

More first downs from supporting efficacy studies for other label claims are still required to gain additional touchdowns and win the Approval Super Bowl game.

 FOURTH QUARTER OF THE APPROVAL SUPER BOWL GAME

The fourth quarter of the Approval Super Bowl game is more difficult because players are tired and the U.S. Aquaculture Team has been penalized by (1) cutbacks in funding, (2) delays in reviews of submissions by officials, (3) increased safety issues, and (4) new tasks outside of the original game plan (efficacy studies and environmental assessments).  To gain touchdowns with complete data packages, more new players are needed to execute the efficacy study plays.  The rest of the team has moved the ball down the field toward the goal line for the other data requirements and the officials are no longer delaying the reviews of submissions.

Table 2.           Approvals (touchdowns) are possible in the near future for indicated label claims except supporting efficacy studies are needed to complete the data package for approvals  

Drug	Type of Treatment: Control or Prevent	Diseases	Fish Group
Copper Sulfate	Control or prevent	Fungi on fish eggs	All fish eggs
Formalin	Control or prevent	Fungi on fish	Cool- and warmwater fish
Hydrogen Peroxide	Control or prevent	Fungi on fish eggs	Cool-and warmwater fish
	Control or prevent	Fungi on fish	All fish
	Control or prevent	External flavobacteriosis	All fish
	Control	External parasites	All fish
Oxytetracycline	Control	Systemic flavobacteriosis	Cool-and warmwater fish

If the plays (efficacy studies) identified in Table 2 are executed successfully, our team will score approvals for these label claims and move closer to a win for the U.S. aquaculture community.  If the team does not advance the ball with more supporting efficacy studies and score as needed, we may lose or be forced into overtime to win the Approval Super Bowl game.

 WINNING THE APPROVAL SUPER BOWL GAME IN OVERTIME!

To win the Approval Super Bowl game in overtime, a concerted team effort is required until 2002 from all the players especially those on the special teams who will execute the supporting efficacy studies.  More supporting efficacy studies would guarantee drug approvals for many or all fish species.

 Table 3.  The following label claims require efficacy data in addition to other data to gain approvals (touchdowns) by 2002