The FDA's handling of the infant formula shortage was a point of contention during the budget hearing.
His appearance before a House subcommittee occurred just a day after President Biden invoked the Defense Production Act and authorized the use of planes to ferry baby formula from overseas to boost supply. The agency and the White House have raced in recent days to respond to the public outcry over bare grocery store shelves and concerns that desperate parents were rationing their stock.
The F.D.A. discovered evidence of a potentially deadly bacteria at the plant that was shut down in February. The company launched a major recall that resulted in gaping holes in the supply chain. There have been at least two deaths and several cases of illness in babies since last fall.
Dr. Califf told lawmakers that the agency was looking into the matter to see if any errors were made. Lawmakers pressed Dr. Califf for a timetable to provide relief for families, and he listed some efforts underway, including relaxed guidelines for imports and increased domestic manufacturing. He said store shelves would not return to normal for weeks after the Abbott plant reopens.
The House Committee on Appropriations pressed Dr. Califf to account for the agency's slow response to clear problems and an alarming whistle-blower report. There were events leading up to the recall, including a September inspection that turned up evidence of the bacteria in finished formula and a whistle-blower report.
Why did the F.D.A. take four months to be pulled off the shelf? The F.D.A.'s slow response caused more illnesses and deaths.
Dr. Califf pointed out that the Justice Department reached a settlement with Abbott requiring heightened safety measures and an independent overseer at the plant.
Dr. Califf said that they anticipate that additional products can be found in U.S. stores. He warned that distribution would still be a concern in certain areas.
The baby formula shortage worsened after the Abbott plant was recalled, which made 25 percent of the U.S. supply. Sales of baby formula began to surge as stock began to fall, most likely due to a wave of panic buying.
The F.D.A.'s plan to ease barriers to foreign formula imports would allow unsafe products into the country, given voluntary safety guidelines.
The agency had the power to reject any application.
He was questioned about the findings of the CDC and the agency, based on samples of the cronobacterbacteria associated with two of the four infants who fell ill in recent months. The five strains ofbacteria found at the plant were compared with those found in those people. There was no match between the agencies and Abbott.
The F.D.A. investigation would continue, according to Dr. Califf.
It is not possible to say until the investigation is complete that the cases came directly from that plant.
A growing problem. A nationwide shortage of baby formula has left parents confused and concerned. There are ways to manage uncertainty.
Finding a formula. If your baby's formula wasn't affected by the recall, you can call your local store and ask when it will be back in stock. You can buy it online. If your baby is on special formula, you should reach out to your doctor's office.
A new formula is being picked. If you use a name-brand formula, look for a generic version. If you want a new formula that matches your usual one, seek it. If your baby is on a special formula, make sure to check with your doctor.
A new product transition. You want to switch your child gradually. Gradually phase out the old product when you mix three quarters of your usual formula with one quarter of the new one. If you can transition gradually because you have run out of your usual formula, it's fine.
What not to do. If you can't find your baby's usual formula, don't make your own, homemade formulas are often inadequate and at risk of being contaminated. Don't try to stretch your formula by adding more water, and don't buy it from unvetted online marketplaces. Don't use toddler formula for a baby less than a year old.
The agency had not deemed an on-site inspection critical even though domestic on-site reviews had been suspended because of the Omicron surge. The agency notes in its review that failing to prioritize the baby formula inspection might be a lapse.
The House and the Senate are considering various proposals that would require more oversight of food safety and improve the supply chain for formula.
The House approved an emergency injection of $28 million for the F.D.A. and a bill to relax limits on the types of formula that can be purchased with benefits from the Special Supplemental Nutrition Program for Women, Infants and Children. Half of the formula sold in the United States is purchased with the help of the Women, Infant and Children program. Changes to the federal food aid program are expected to be approved by the Senate.
The $8.4 billion budget would be $2.1 billion more than last year. An increase in food safety funding would go toward improving technology to quickly trace foodborne illnesses to their source and other efforts to reduce toxins in food.
Senate Republicans were expected to oppose additional funding for the F.D.A. In a notice sent to rank-and-file lawmakers, Republican leaders criticized Democrats for abandoning bipartisan efforts and instead offering legislation with no plan to actually fix the problem, all while failing to hold the F.D.A. accountable.
The House Energy and Commerce Committee will hold a hearing next week on formula safety and supply.
Senator Ron Wyden, a Democrat from Oregon, announced a Senate Finance Committee investigation into Abbott's investments in safety improvements.
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