WASHINGTON, Sept. 17, 2014 -- An international group of 89 scientists and technology company executives is urging President Obama to order the FDA to speed up its approval process for new biotech products, saying the current process takes way too long and is damaging the agency’s credibility.

In a letter, the group, which includes Richard Roberts, winner of the 1993 Nobel Prize in medicine, asks Obama’s help on an issue which the signees say directly impacts “global and domestic food security, the ability of scientists to respond to the impacts of human and animal disease” as well as climate change and the spirit of invention.

The letter specifically refers to approval process for the AquAdvantage Salmon developed by AquaBounty Technologies Inc., which has been before the FDA for 19 years. Four years ago, the FDA’s Veterinary Medicine Advisory Committee (VMAC) found, among other things, that AquAdvantage Salmon grow faster and are nutritionally equivalent to conventional Atlantic salmon and that the genetic construct did not harm the fish.

The signees argue AquaBounty has gone above and beyond in the federal regulatory process, even an “unprecedented” public comment period for its environmental assessment, which was not required by federal law.  In December 2012, FDA issued a finding of no significant impact, which is the last step required before FDA can issue its final decision.

The signers of the letter contend the issue is much deeper than this one case, but instead is a reflection of uncertainty in the FDA review process.

“The obvious regulatory roadblocks AquaBounty is experiencing not only undermine our ability to meet the future food needs of the world, but seriously damage the global credibility of FDA and its objective, science-based approval process, while stifling innovation in this critical field,” the scientists and executives wrote.

The group said biotechnology has the potential to make a real impact on the increasing amount of food needed to feed a growing world population, but said FDA needs to rely on science instead of public opinion.

“Protests by anti-technology interests are, we believe, the root cause of the unconscionable delays in FDA approval,” the letter said. “These groups’ criticisms are based on misplaced economic/marketplace concerns and reactionary fears of people who either don’t understand or choose not to understand the science behind the AquAdvantage Salmon.

“The inexplicable regulatory bottleneck encountered by the AquAdvantage Salmon gives credence to those who publicly contend FDA regulation is based on politics and public opinion rather than science.”

The group called on Obama to affirm his stated belief in biotechnology and instruct FDA to “move as efficiently as possible” to conclude its review and issue a final decision in the AquAdvantage Salmon case.

“As you publicly recognize, biotechnology not only benefits Americans, but is increasingly important to farmers around the world,” the letter said. “We firmly believe it is time FDA action give credence to your administration’s public support of biotechnology.”


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