LAWMAKERS GRILL FDA CHIEF ON FORMULA OVERSIGHT
Defense Dept. to bring in supplies; Senate OKs WIC bill
The head of the Food and Drug Administration told lawmakers Thursday that a shuttered baby formula factory could be up and running as soon as next week, though he sidestepped questions about whether his agency should have intervened earlier to address problems at the plant that have triggered the national shortage.
FDA Commissioner Dr. Robert Califf faced a bipartisan grilling from House lawmakers over the baby formula issue that has angered American parents and become a major 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 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.”
When lawmakers asked why it took the FDA months to investigate a whistleblower complaint about safety violations at Abbott’s plant, Califf said he couldn’t share details due to the agency’s ongoing investigation. Several lawmakers rejected that response.
Rep. Rosa DeLauro, DConn., repeatedly asked Califf to explain what the FDA did after receiving a whistleblower complaint in October alleging numerous safety violations at Abbott’s plant, including employees falsifying records and failing to properly test formula before releasing it. The former Abbott employee wasn’t interviewed by the FDA until late December and the plant wasn’t closed until mid-February, she noted.
“It all begs the question, why did the FDA not spring into action?” DeLauro asked.
Califf said he had reviewed the complaint but didn’t specify when or what immediate steps were taken.
“I am committed to getting back to you on specifics of what happened, I’m just not prepared to today,” Califf 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 political 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.
On Thursday evening, the White House announced that the Defense Department would help transport about 1.5 million 8-ounce bottles of formula from Zurich to Plainfield, Ind., for distribution in the United States. The formulas — Alfamino Infant, Alfamino Junior, and Gerber Good Start Extensive HA — are for children who are allergic to cow’s milk protein, according to a White House statement.
Meanwhile, the Senate on Thursday unanimously approved a measure that would expand what kind of formula can be purchased using benefits from the federal food aid program for women and babies. About half the formula sold in the United States is purchased with benefits from the Special Supplemental Nutrition Program for Women, Infants and Children, known as WIC.
Without formally taking a vote, the Senate sent it to Biden for his signature a day after the House overwhelmingly passed the legislation. The fate of a separate $28 million emergency aid package for the FDA is more tenuous amid Republican opposition.