“The FDA has no intention of relinquishing our public health mandate,” FDA Commissioner Stephen Hahn tweeted Tuesday, after the USDA announced the deal.
The agency’s career lawyers had previously objected to the so-called Memorandum of Understanding, people with knowledge of the discussions told POLITICO.
Hahn in recent days has repeatedly refused to sign the agreement – including resisting pressure from HHS on Monday to consent to the MoU, according to a senior HHS official.
Instead, HHS Assistant Secretary of Health Brett Giroir signed the MoU instead – a move that further angered FDA officials, who have spent months fighting HHS’s efforts to undermine the agency’s regulatory power.
“This is a last-minute ave maria,” said the senior HHS official. “It is a total assignment of FDA authority to the USDA.”
An HHS spokesman said the last-minute deal was conducted by the White House, which coordinated a “formal political process”, and came despite the reservations of HHS secretary Alex Azar.
Azar “supported and continues to support Commissioner Hahn and the FDA’s position on the MOU, but at the direction of the White House, a decision was made to execute the MOU,” said the spokesman. 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 “paves the way for bringing our regulatory framework into the 21st century, putting American producers on an equal footing with their competitors around the world. In the past, regulations have stifled innovation, making American companies try to recover and give up market share. ”
The pork industry has been leading the plan on behalf of the USDA. The National Pig Producers Council, the largest lobbying group in the industry, said in a statement on Tuesday that it plans to work with the Biden government “to implement a technology that has the potential to improve animal health, further reduce the footprint. agriculture and improve production efficiency. “
Still, the FDA for years resisted calls from the agriculture lobby to relinquish its oversight, a request that the industry pressed in part because it believes the USDA would grant approval more quickly. Throughout its history, the FDA has authorized only two animals for consumption produced using these methods: genetically modified salmon and pigs safe for people with a certain allergy.
In the face of increasing pressure to sign the agreement last week, FDA officials argued that the agreement would violate the agency’s public health mission by giving up oversight of genetic changes that could directly affect humans. The document published on Tuesday requires that the USDA only “consult” the FDA in many cases, a vague requirement that the agency argued would not be subject to legal scrutiny.
“With this MoU, the industry has achieved public health,” said the senior HHS official. “It is a dark day for the agency.”