The head of the Food and Drug Administration told lawmakers on Thursday:He could start work next week, though he left unanswered questions about whether his agency should have intervened earlier in the factory’s headquarters. .
FDA Commissioner Robert Califf faced a two-sided grudge from House lawmakers over the baby food issue.and it became a political responsibility for President Joe Biden.
The problems are largely tied to the Abbott plant in Michigan, the largest in the US.. The FDA announced earlier this week that it has entered into a preliminary agreement with Abbott to restart production pending safety upgrades and certifications.
“We had to wrestle this with Abbott,” Califf told members of a House subcommittee, “I think we’re on track to open it in the next week to two weeks.”
Abbott said it could take about two months for the new formula to reach stores after production resumes.
When lawmakers asked why the FDA took months to investigate warnings of safety violations at the plant, Califf said he couldn’t say much because of an ongoing investigation into the problems. Some lawmakers rejected this answer.
“It is unacceptable to say that you cannot comment on this,” said Representative Mark Pocan of D-Wisconsin. “This is a problem I see over and over with the FDA: You guys are not good at communicating.”
Califf is the first administration official to testify before Congress on the shortfall that has caused some families to seek formula and become a talking point for Republicans. On Wednesday evening, Biden announced that he is taking sweeping new steps to improve US supply.Flying with Defense Production Act and formula imported from overseas.
Members of the House Appropriations subcommittee opened Thursday’s hearing by asking Califf why the FDA did not take action when there were warnings of problems at the Sturgis, Michigan plant last fall.
Representative Rosa DeLauro of D-Conn. pointed to a recent whistleblower complaint alleging multiple security breaches, including employees at Abbott’s facility falsifying records and failing to properly test the formula before releasing it. He said the former Abbott employee alerted the FDA about the situation in October, but was not consulted by agency staff until late December.
“They all ask the question, why didn’t the FDA take action?” ‘ DeLauro asked. “Who in the leadership had access to this report – who did not have access to it – and why was there no reaction?”
Califf said he was reviewing the complaint, but did not specify when or what immediate action had been taken. He said the allegations raise serious concerns about Abbott’s operations.
“The most worrying accusation is that the integrity of the organization has been compromised,” Califf said. Said. “Once that integrity is compromised, the question is how can you trust any of the existing systems.”
Subcommittee Chair Representative Sanford Bishop, D-Georgia, called the delay in FDA action “unreasonable.”
“The American public trusts the FDA to protect infant health by giving them access to safe formula,” Bishop said. Said.
Abbott closed its Michigan plant in February after FDA investigators began investigating four bacterial infections in infants who consumed formula from the plant. The first of these cases was reported to the FDA in September, but agency staff did not begin examining the facility until late January. Califf said earlier this week that the agency’s investigation is ongoing and has yet to come to a conclusion as to whether bacteria in the plant cause infant infections.
Abbott said there is no direct evidence linking his products with diseases.
The baby food shortage is the first major crisis for Califf since then.. He briefly ran the agency under the administration of former President Barack Obama and was again nominated for the job based on his past experience managing the expanding agency that regulates food, medicine, medical technology and tobacco.
Thursday’s hearing is scheduled to review the FDA’s budget request for next year, and Califf has sought $76 million in new funding from lawmakers for food safety and nutrition.
“I was very aware that we needed to make big improvements on the food side of the FDA – not because people are bad – that consistent leadership and the right resources are needed,” Califf told lawmakers.
The request for funding came amid long-standing concerns that the FDA’s food program, which oversees most U.S. foods excluding meat, poultry and eggs, is underfunded compared to the agency’s drug and medical divisions.
On Wednesday evening, the House of Democrats approved a $28 million spending bill that will increase FDA funding to oversee local and international formula makers. His fate in the Senate is uncertain.