PDUFA and how possible amendments regarding genetically modified salmon negatively effect Arizona

A key requriement for our bioscience community to keep movng forward faster is the approval of the 2012 PDUFA agreements.  Something fishy could hold things up and AZBio shares the G2 on why this is not a good idea.


Ms Judith Gheuens
Legislative Assistant
to Senator Jon Kyl                                                                                                                                                                   


Dear Ms. Gheuens,

It was a pleasure meeting with you in your offices on April 25th .  During our meeting I promised to keep you in the loop on upcoming items effect our state and specifically our growing bioscience industry.   Then, just one week later, I had the pleasure of hearing the Senator when he and Congressman Jeff Flake came to speak to all of us at the Arizona Chamber Event held in their honor.

It has come to my attention that one or more amendments regarding the Food and Drug Administration’s (FDA) review of a genetically enhanced salmon application will be offered when the critical prescription user fee agreement legislation (PDUFA) is debated in the Senate this week or next week.

We do not normally connect Arizona and salmon, but the proposed  amendments relating to the FDA’s scientific review of genetically enhanced salmon, including potential amendments that would prevent the FDA from ruling on the product or delay the FDA from ruling by requiring additional costly and time-consuming studies do affect our bioscience community and our state due to the precedent that could be set for other food products that are native to our state as well as other unrelated products that also fall under FDA jurisdiction when the FDA’s current science-based food labeling or other policies in place.

All of these potential amendments subvert the FDA’s science-based regulatory system and set a dangerous precedent of disrupting FDA’s independent reviews of innovative new drugs, products, and applications.  The precedent created by these amendments impacts all biotechnology companies who rely on the FDA’s science-based, independent and predictable review process, not just this particular application.

In addition, these controversial amendments would disrupt the debate on the underlying prescription user fee agreement legislation, which is the product of a significant amount of very hard work and compromise in the Senate.  The legislation needs to become law by the end of the fiscal year so that the FDA can continue to move new products forward in the pipeline based on the established science-based protocols, and these amendments threaten to upset the carefully created balance of this particular bill.

Please don’t hesitate to contact me with any questions.


Joan Koerber-Walker
President and CEO
Arizona BioIndustry Association



Posted in Advocacy and Regulations, AZBio News, BioScience, CEO, Government Affairs Blog, In the Loop, Inside the Belt Way.