FDA Commissioner Stephen Hahn said, “The FDA has no intention of supporting our public health mandate Tweeted The agreement was announced by the USDA after Tuesday.
The agency’s career lawyers had already lodged several objections to the so-called memo, people with knowledge of the discussion told Politico.
According to a senior HHS official, in recent days Hahn has declined on several occasions to sign the agreement – including HHS pressure from Monday to concurrence.
Instead, HHS assistant secretary of health Brett Giroir signed an MoU in his place – a move that angered FDA officials who have spent months fighting HHS’s efforts to wipe out the agency’s regulatory power.
“This is a last-minute Hell Mary,” said a senior HHS official. “This is the total seeding of FDA authorization to the USDA.”
A HHS spokesman said the last-minute agreement was moderated by the White House, which coordinated the “formal policy process” and came despite HHS Secretary Alex Azar’s own reservations.
Azar said, “The commissioner on the MOU supports the position of Hahn and the FDA, but upon the White House’s directive, it was decided to execute the MOU,” the spokesman said. The White House did not immediately respond to a request for comment.
Secretary of Agriculture Sunny Perdue issued an agreement saying it paved the way for us to bring our regulatory framework into the 21st century, which has brought American producers to the playground with their competitors around the world . In the past, regulations accelerated innovation, which led to American businesses playing catch-up and seated market share. “
The pork sector has been a frontrunner for the scheme from the USDA. The industry’s largest lobbying group, the National Pork Producers Council, said in a statement on Tuesday that it plans to work with the Biden administration “to implement a technology that includes improving animal health, agriculture’s environmental footprint.” Ability to reduce and improve efficiency. “
Yet for years the FDA had resisted calls from the agricultural lobby to request its supervision, as the industry pushed for part because they believed the USDA would approve them more quickly. Throughout its history, the FDA has signed only two animals for consumption produced using these methods: genetically engineered salmon and pigs safe for people with a certain allergy.
Amid increasing pressure to sign the agreement last week, FDA officials argued that monitoring genetic changes would violate the agency’s public health mission that could directly affect humans. The document published on Tuesday required only the USDA to “consult” with the FDA in many cases, a vague requirement that the agency argued would not last until a legal investigation.
A senior HOS official said, “With this MoU, the industry won over public health.” “It’s a dark day for the agency.”