FDA's science-based review procedures are based on the Agency's objectivity. (Photo: FDA)
Coalition calls for Congress to back off from FDA approval process
Friday, August 05, 2011, 23:10 (GMT + 9)
A letter from 38 industry groups was sent this week to top federal government officials requesting that members of Congress should not interfere with the science-based regulatory process conducted by the Food and Drug Administration (FDA).
The letter is related to the two sent two weeks ago by several Senators and representatives asking the FDA to halt the review process of AquaBounty’s AquAdvantage salmon, which would be the first genetically modified (GM) animal intended and approved for human consumption.
Members of the Animal Agriculture Coalition, including BIO, the world's largest biotechnology organisation, wrote to express their deep concern regarding recent action in the US House of Representatives to amend HR 2112, the Fiscal Year 2012 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, to bar the FDA from using appropriated funds to finalize its review of an application for the transgenic Atlantic salmon.
The amendment by Alaska Republican Rep Don Young (R-AK) was passed by vote in June. He argued that the “alien fish” would wreak havoc with wild salmon populations in Alaska’s waters.
The letter was addressed to Speaker of the House John Boehner, Democratic Leader Nancy Pelosi, Majority Leader Harry Reid and Minority Leader Mitch McConnell.
“We do not write to support or oppose this specific application, but rather to register our concern with the House’s action, which if allowed to become law, would disrupt the FDA’s Congressional mandate to base its assessments of human and animal drugs, devices, vaccines, and process applications on the best-available science underlying an application. Such a disruption would diminish the credibility of the FDA approval process at home and overseas,” the letter reads.
“The global reputation of FDA’s science-based review procedure is based on the Agency’s objectivity,” the authors warn.
The letter also highlights that at a June hearing to analyze the benefits of agricultural biotechnology held by the House Agriculture Committee’s Subcommittee on Rural Development, Research, Biotechnology and Foreign Agriculture, global hunger expert Dr Calestous Juma, currently serving on the staff of Harvard’s Kennedy School of Government, testified that what is at stake is not AquaBounty’s salmon but instead “the principle behind the amendment and its wider ramifications.”
He said the rest of the world would receive the message that the science-based regulatory oversight as embodied in the FDA review process is highly susceptible to influence from political intervention.
“Furthermore, it signals to the world that the US may cede its leadership position in the agricultural use of biotechnology. . . I believe it is imperative that the US stay the course it has set in not letting politics interfere with its science-based regulatory system that is truly the envy of the world,” Juma added.
In their letter, the Members of the Animal Agriculture Coalition said they share Juma’s views and strongly urged the federal government officials to reject the House-passed provision.
- Lower chamber votes to bar FDA from using funds to approve GE salmon
- Congress steps up opposition to GE salmon
By Natalia Real