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AquAdvantage Salmon: A Regulatory Odyssey

April 24, 2013
At BIO 2012, an article was published on AquaBounty Technologies which told the tale of the Company’s New Animal Drug Application (NADA) for AquAdvantage Salmon.  At that time, the Company had completed all the required major elements for an FDA approval and FDA had held a thorough public airing before its Veterinary Medicine Advisory Committee (VMAC) of the results of the agency’s Center for Veterinary Medicine’s (CVM) review of AquaBounty's application.

Following the meeting of the VMAC, we expected FDA to proceed promptly with its commitment prior to acting on our NADA to issue, for public comment, CVM’s draft “Environmental Assessment” (EA) of the proposed “conditions of use” specified in our NADA.  After approximately 18 months had passed with no movement on FDA’s part to publish the EA, we made a concerted effort to determine the status of the publication and the basis for delay.  We were confronted by the reality that no one at FDA, the Department of Health and Human Services, OMB, or the White House was authorized to respond to our most basic questions as to the status of the EA.

We surmised that in light of the fact that 2012 was an election year an "embargo," for political reasons, had been placed on all information related to the application and no federal agency was authorized to apprise the firm of its status.  Finally, in December of 2012, matters were clarified by JonEntine’s report in the online publication Slate.  Mr. Entine had acquired a leaked copy (from an unnamed government source) of the Environmental Assessment (EA) for AquAdvantage Salmon, which was dated April 19, 2012 and had managed to communicate with officials apparently knowledgeable about our situation. Mr. Entine, an Executive Director of the Genetic Literacy Project and a former television producer turned investigative journalist, had followed the threads of the story and unearthed new information on the handling of the AquAdvantage Salmon application.  It became clear that the delay had not been due to science-based issues, but rather, as we had surmised, to a deliberate politically-driven embargo by the White House.  Two days after the Slate article was published - and after two years of delay and refusals to identify either the basis for or the entity or entities causing the delay - FDA announced its intention to release the AquAdvantage Salmon EA for public comment.

A notice of the availability of the EA draft document was published in the Federal Register on December 26, 2012.  The notice advised that the public comment period would be 60 days and that no extension would be considered, since the information in the EA had been available for over two years.  Two weeks later, several US Senators sent a letter to Commissioner Hamburg requesting an extension.  On February 14, in response, FDA, without meaningful explanation, announced a further 60 day extension of the public comment period.   The public comment period is now scheduled to close on April 26, 2013.

It should be pointed out that there is no legal requirement for posting the EA for public comment prior to approval of an NADA and that the agency’s decision to publish the draft EA for comment prior to acting on our petition is, like the VMAC hearing and the sharing of the results of CVM’s review, an apparently sincere effort by FDA to enhance the "transparency" of the NADA approval process.  Forgive me, but I cannot resist inviting those of you with a cynical inclination to juxtapose this exercise of transparency with the frank refusal by the Administration for well over a year to provide AquaBounty information on the status of the EA or the reason for or source of the delay in action on the EA.  Even getting a reply that they had received our inquiries was a daunting task.

Mr. Entine's December exposé detailed the delayed regulatory action on a legitimate application for political purposes during an election year.  He also exposed the political maneuvering, the intrusive legislative initiatives, and the overall “policy” (as opposed to legal or scientific) controversy associated with a statutorily-driven scientific review process.

The effects on AquaBounty of this chain of delay and controversy have been significant.  Because our application is the "first in class" for a transgenic food animal, we have become the target of all the anti-technology groups.  Attacks on our science and application have been brutal and often dishonest.  We have suffered financially and we fear that the burgeoning animal biotech industry has lost the confidence of the investment community.  Perhaps even more significant is the potential loss of an entire segment of American technology, i.e. genetically engineered animals - a technology that has the real potential to help meet global food security needs for the next century may very well flourish in countries other than the U.S.

In the time between the VMAC meeting in 2010 and today, AquaBounty has had to respond to eight separate legislative initiatives in  the US Congress to either ban or label AquAdvantage Salmon - a product that is not on the market and has not yet received regulatory approval. Most of the congressional opposition has come from the Alaskan delegation; at least one of whose members privately acknowledges that their arguments with respect to the injury to their state's wild salmon industry are rooted in economic rather than science-based or science-supported concerns.  Not only has no empirical basis for economic concern been established, but also "wild caught" Pacific salmon are distributed and marketed in a completely separate channel compared to Atlantic salmon - and will in all reasonable likelihood so continue.

We have also been the target of anti-technology protests, NGO publications and dishonest letters to the food industry characterizing our product as unsafe or dangerous.  These attacks frequently contain  distortions  or misleading information with respect to our data as well as the published findings of FDA.  Given that action on our application has been taken and we have no product that can be lawfully marketed, there is little legal recourse for the Company, even in the face of disparaging and damaging commentary.  I suggest that these efforts are not consistent with the transparency and integrity we teach our children in Civics class.  In my view, the attacks by the anti-technology groups are a disservice to AquaBounty and to FDA.  They also appear to threaten the integrity of the very principle the groups profess to espouse, that is public participation in the approval process.  If there is not integrity in the process, there is the very real risk that the process will foster the lowest form of misinformation and political manipulation.

Yet today, I am able to write the latest installment of our odyssey for this year's BIO Meeting. Part of the reason this is possible is due to committed investors and staff.  Also important in our survival has been the commitment and help of BIO in opposing the legislative initiatives and in defending the industry against the biased attacks by the opponents of this technology.  BIO presents a voice for all biotechnology companies, but it is particularly critical to small firms like AquaBounty that do not have the resources to "have a voice" on these issues.  The BIO Communication teams, its Legislative Affairs team, and the larger BIO staff all provide a critical resource to respond to these constant challenges to our industry.  I remain hopeful that a year from now I will be able to write another chapter of the AquAdvantage Salmon odyssey for the BIO 2014 meeting, one that describes a successful conclusion to AquaBounty’s regulatory journey.

Ron Stotish is the CEO of AquaBounty Technologies