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“The FDA has no intention of abdicating our public health mandate,” said Stephen Hahn, commissioner of the FDA. tweeted Tuesday, after USDA announced the deal.
The agency’s career lawyers had already raised several objections to the so-called memorandum of understanding, people with knowledge of the talks told POLITICO.
Hahn has repeatedly refused in recent days to sign the deal – including resisting pressure from HHS on Monday to consent to the memorandum of understanding, according to a senior HHS official.
Instead, HHS Assistant Secretary of Health Brett Giroir signed the memorandum of understanding in his stead – a move that further outraged FDA officials who have spent months fighting the efforts of the HHS to erode the agency’s regulatory power.
“This is a last minute Hail Mary,” the senior HHS official said. “It’s a complete cession of authority from the FDA to the USDA.”
An HHS spokesperson said the last-minute deal was led by the White House, which coordinated a “formal political process,” and came over HHS Secretary Alex Azar’s own reservations.
Azar “was and continues to support Commissioner Hahn and the FDA’s position on the MoU, but under the leadership of the White House the decision was made to execute the MoU,” said the spokesperson. The White House did not immediately respond to a request for comment.
Agriculture Secretary Sonny Perdue was quick to praise the deal, issuing a statement that it “paves the way for bringing our regulatory framework into the 21st century, putting American growers on the line. on par with their competitors around the world. In the past, regulations stifled innovation, causing US companies to catch up and give up market share.
The hog industry led the charge for the plan on behalf of the USDA. The National Pork Producers Council, the industry’s largest lobbying group, said in a statement Tuesday that it plans to work with the Biden administration “to implement technology that has the potential to improve animal health, further reduce the environmental footprint of agriculture and improve production efficiency. “
Yet for years the FDA had resisted calls from the agriculture lobby to cede its oversight, a demand the industry pushed for in part because it believes the USDA will give them approval faster. . Throughout its history, the FDA has only approved two animals for consumption produced using these methods: genetically modified salmon and pigs safe for people with a certain allergy.
Amid mounting pressure to sign the deal over the past week, FDA officials argued that the deal would violate the agency’s public health mission by abandoning surveillance for genetic alterations that could directly affect humans. The document released Tuesday forces the USDA to “consult” the FDA only in many cases, a vague requirement that the agency said would not withstand legal scrutiny.
“With this memorandum of understanding, the industry has won public health,” said the senior HHS official. “It’s a dark day for the agency.”
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