Recently the FDA approved a number of gene therapy products to treat childhood and young adult leukemia, non-Hodgkin lymphoma, and forms of congenital blindness. The guidelines for giving the green light to Novartis, Kite Pharma and Spark Therapeutics, the companies responsible for producing these new genetic treatment protocols are covered in a new document entitled, “Chemistry, Manufacturing, and Control  Information for Human Gene Therapy Investigational New Drug Applications.”

Gene therapies involve the transfer of healthy genetic material into gene sequences to replace bad genes responsible for a particular medical condition. Regenerative medicine involves the therapeutic re-engineering and regrowth of cellular tissue of all types from organs, to bones, to nerves, blood vessels, and the like.

In announcing the new guidelines an FDA spokesperson and health policy expert described how different these new therapies are from traditional drug development and treatment protocols. Whereas the focus in the latter is 80% on clinical issues, when it comes to gene therapies and regenerative medicine the 80% is on manufacturing looking at:

• the description of the manufacturing process,
• process controls,
• cell culture conditions,
• material controls including the identification of the amount of material to be produced for testing,
• cell bank qualification and characterization,
• process validation,
• and finally the end manufacturing process including the quantity of material being produced.

The FDA also has included long-term follow-up guidance for gene therapy and regenerative medicine products. The Agency admits it is still on a learning curve to understand how these new therapies work and what is considered safe in the long term. But in the interest of initial results from laboratory and clinical trials, the goal is to approach these forms of medical treatment with an evolving strategy based on the rapid evolution of the science. So expect to see frequent revisions to FDA treatment protocols as new genetic and regenerative medical therapies are announced by biopharmaceutical companies and academic researchers.

The FDA found that the genetic modification was safe for the fish itself based on extensive examination. The nutrition and food value was determined to be as safe as any other Atlantic Salmon raised by fish farms. And finally the environmental assessment of AquaBounty Technologies, the Canadian company that developed the genetically modified fish determined that the production, facilities and physical barriers created to separate the fish from wild stocks met its standards for safety. Raised fish from AquaBounty can never intermingle and breed with existing wild fish stocks. All AquAdvantage Fish are sterile.

Anti-GMO critics were quick to pounce on the announcement from the FDA, referring to the AquAdvantage as a “frankenfish.” The FDA received 1.8 million letters opposing approval including celebrity demands that the fish be labeled genetically modified when sold on grocery shelves.

The concern about food safety from consumer groups, while always warranted, is invalid in this case as it is with all GMOs. The science of GMO is no different from selective breeding. The targets are different. Instead of modifying the seed-germ through experimental cross breeding, GMO science makes the change in the RNA and DNA. No one has ever gotten sick from eating GMO foods. And in fact some GMO foods are saving lives every day and ensuring that young people in the Developing World don’t go blind from Vitamin A deficiency.

The truth about the safety of GMOs is not based on science but on emotion. And when you add the names of the chemical companies that are GMO advocates, like Monsanto, Bayer, Dupont and BASF, responses are even more virulent. These corporations are seen as manipulative and monopolistic in the agribusiness world. The result, quality aquaculture research by companies like AquaBounty Technology gets lost in the emotional debate. That’s what makes resistance to GMO science so much harder to overcome.