U.S. Food and Drug Administration Commissioner Robert Califf on Thursday told House lawmakers that a baby formula factory on hold due to safety concerns could soon open, noting that he and his agency were working closely with the manufacturer and receiving regular updates on their progress.
Califf faced a bipartisan grilling from House lawmakers over the baby formula issue that has angered American parents and become a political liability for President Joe Biden.
The problems are largely tied to Abbott Nutrition’s Michigan formula plant, the largest in the U.S., which has been closed since February due to contamination problems. The FDA announced a preliminary agreement with Abbott earlier this week to restart production, pending safety upgrades and certifications.
“We had to really wrestle this to the ground with Abbott,” Califf told members of a House subcommittee. “I think we are on track to get it open within the next week to two weeks.”
Califf said he gets a report twice each day on Abbott’s progress and that the company has begun to resolve a “number of issues.”
Lawmakers also pressed Califf on why his agency did not act sooner to a whistleblower complaint sent back in October alerting the FDA to potential safety issues at the Abbott factory.
“Whomever looked at that report felt that there was no need to respond at all from October to February until there was a recall. That is a dereliction of duty, in my view,” said House Appropriations Chair Rosa DeLauro, D-Conn.
Califf said he couldn’t say much due to an ongoing investigation into the issues. Several lawmakers rejected that response.
“It’s not acceptable to say you just can’t comment on it,” said Rep. Mark Pocan, D-Wisconsin. “This is a problem I’ve seen over and over with the FDA: You guys aren’t good at communicating.”
Califf did say he had read the whistleblower report and found that the “most concerning charge is that the integrity of the organization was compromised.”
“So once that integrity is compromised, then the question is: How can you trust any of the systems that are in place?” the FDA chief said.
Califf is the first administration official to testify before Congress on the shortage, which has left some parents hunting for formula and become a talking point for Republicans. On Wednesday evening Biden announced sweeping new steps to improve U.S. supplies, including invoking the Defense Production Act and flying in imported formula from overseas.
The administration's latter effort is called Operation Fly Formula, which will involve using Department of Defense contracted planes to transport formula from qualified manufacturers to the U.S. for FDA inspection, bypassing the normal, slower import process.
Senior administration officials on Thursday did not say when the first plane of formula might arrive, just noting that they were in active "conversations" with manufacturers about where there might be available cargo.
"Then we will, from there, work through vendors and retailers to come to that manufacturing facility to pick it up and hopefully get it out to the communities that are most in need," one official said.
Abbott shut its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. The first of those cases was reported to the FDA in September though agency staff didn’t begin inspecting the facility until late January. Califf said earlier this week the agency’s investigation is ongoing and it hasn’t yet reached a conclusion on whether bacteria from the plant caused the infant infections.
Abbott has said there is no direct evidence linking its products to the illnesses.