Industry: Don’t undermine FDA process


Steven Hedlund

Published on
August 2, 2011

Thirty-eight industry groups on Tuesday asked Congress to avoid interfering in the U.S. Food and Drug Administration’s science-based process of approving human and animal drugs, devices and vaccines.

The recommendation comes nearly three weeks after 23 members of Congress (eight senators and 15 representatives) urged the FDA to abandon its approval process for genetically modified (GM) salmon as food, threatening to push legislation to strip the agency’s funding to study the fish if it fails to comply.

The legislators, who include Sens. Mark Begich and Lisa Murkowski, both of Alaska, are primarily from the coastal states of Alaska, Washington, Oregon and California. They are concerned about the potential negative effects of GM salmon, including the impact on wild salmon populations.

In a letter to Reps. John Boehner and Nancy Pelosi and Sens. Harry Reid and Mitch McConnell, the 38 industry groups said such legislation “would disrupt the FDA’s congressional mandate to base its assessments of human and animal drugs, devices, vaccines … on the best-available science. Such a disruption would diminish the credibility of the FDA approval process at home and overseas. The global reputation of FDA’s science-based review procedure is based on the agency’s objectivity.”

The groups clarified that they are not writing to support or oppose AquaBounty Technologies’ application. Last September, FDA scientists preliminary determined that the GM salmon developed by the Waltham, Mass., biotechnology firm, called AquAdvantage Salmon, is safe for human consumption, though an FDA advisory committee later determined that more research is needed. The salmon would become the first GM fish approved for human consumption.

The only seafood-specific groups among the 38 industry groups are the National Aquaculture Association and Catfish Famers of America. The Animal Health Institute, Biotechnology Industry Organization, National Cattlemen’s Beef Association, National Chicken Council and National Pork Producers Council also signed the letter.

The letter cited the testimony of Dr. Calestous Juma of Harvard’s Kennedy School of Government, who addressed the House Agriculture Committee’s Subcommittee on Rural Development, Research, Biotechnology and Foreign Agriculture on 23 June.

“It is not this particular fish that is at stake,” said Juma. “It is the principle behind the amendment and its wider ramifications. It sends the message to the rest of the world that the science-based regulatory oversight as embodied in the FDA review process is subject to political intervention. Furthermore, it signals to the world that the United States may cede its leadership position in the agricultural use of biotechnology.”

Following the legislators’ 15 July letter, Ronald Stotish, president And CEO Of AquaBounty, said he remains confident that other legislators will refrain from interfering in the 15-year scientific review by the FDA.

“The facts about the safety and the environmental benefits of the fish have been made fully public by the FDA,” he said. “It would be a dangerous precedent to react to a handful of legislators’ misinformed paranoia. The real waste of taxpayer dollars would be to abandon the important American principle of science-based regulation, responding instead to economic protectionist fears or subjective and emotional judgments. This is an issue greater than our application, an issue of American leadership in technology, innovation and science-based regulation.”

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