“The FDA does not intend to abandon our public health mandate,” said FDA Commissioner Stephen Hahn tweeted Tuesday, after the USDA announced the deal.
People with knowledge of the discussions told POLITICO that the agency’s career lawyers have already lodged several objections to the so-called memorandum of understanding.
Hahn has refused on several occasions in recent days to sign the agreement – including resisting pressure from HHS Monday to agree to the agreement, according to a senior HHS official.
Instead, Brett Giroir, assistant secretary of health, signed the MoU in his place – a move that would take months of FDA officials fighting HHS’s efforts to destroy the agency’s regulatory power. , further angered.
“This is a last minute Hail Mary,” the senior HHS official said. “This is a total relinquishment of FDA authority to the USDA.”
A spokesman for the HHS said the agreement was promptly driven by the White House, which coordinated a ‘formal policy process’, and this came despite HHS’s reservations, Alex Azar.
Azar “was and still remains the position of Commissioner Hahn and FDA on the MOU, but under the leadership of the White House, the decision was made to execute the MOU,” the spokesman said. The White House did not immediately respond to a request for comment.
Secretary of Agriculture Sonny Perdue quickly praised the agreement and issued a statement saying it ” makes way ‘to bring our regulatory framework into the 21st century and put American producers on a par with their competitors around the world. In the past, regulations have suppressed innovation, catching up with U.S. businesses and giving up market share. ”
The pork sector is leading the cost of the plan on behalf of USDA. The National Pork Producers’ Council, the industry’s largest lobby group, said in a statement on Tuesday that it intends to work with the Biden administration “to introduce a technology that can improve animal health, agriculture can further reduce the environmental footprint and improve production efficiency. ”
Yet for years, the FDA resisted the agricultural portal’s calls to relinquish its oversight, a request that the industry insisted in part because it believed the USDA would grant them faster approval. During its history, the FDA has reported only two animals for consumption produced using these methods: genetically engineered salmon and pigs that are safe for people with certain allergies.
In light of the increasing pressure to sign the agreement last week, FDA officials argued that the agreement would violate the agency’s mission for public health by overseeing genetic changes that could directly affect people. The document, published Tuesday, requires the USDA in many cases to “consult” only with the FDA, a vague requirement that the agency says will not uphold legal scrutiny.
“With this agreement, the industry has won public health,” the senior HHS official said. “It’s a dark day for the agency.”