FDA chief admits slow response to formula shortage

The Food and Drug Administration’s (FDA) response to multiple reports of contamination at a baby formula manufacturing plant was delayed due to a COVID-19 outbreak and numerous logistical failures, the agency’s director told a House panel Wednesday.

FDA Commissioner Robert Califf admitted the agency made a number of missteps that exacerbated a nationwide shortage of baby formula and pledged to reform the agency’s often criticized food safety division.

The FDA’s response was “too slow, and some decisions in retrospect could have been more optimal,” Califf said.

“My basic plan has been to get through this crisis, and we will be looking at the overall food program from the perspective of reforming it but not waiting to deal with the specifics of this case,” Califf said. 

Lawmakers grilled Califf about the agency’s actions leading up to the subsequent shutdown of Abbott Nutrition’s Sturgis, Mich., manufacturing facility and the recall of the formula that was made there. 

They wanted to know why it took months to inspect the plant, even though agency officials knew about long-standing safety conditions. They also pressed Califf about why the agency did not appear to respond to the shortage until it gained national attention.

“Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required to address an infant formula shortage?” said Rep. Morgan Griffith (Va.), the top Republican on the House Energy and Commerce oversight subcommittee.

“I don’t understand how the FDA can justify three months to respond to this crisis. I expect to learn why the FDA did not move heaven and earth in an attempt to get the Sturgis plant back up and running as soon as possible,” Griffith added.

The formula shortage exploded politically in just the past two weeks, leaving lawmakers and the Biden administration scrambling for solutions.

President Biden signed into law a hastily passed bill intended to protect families participating in the government’s nutrition program for women, infants and children.

The White House has invoked the Defense Production Act so ingredient manufacturers prioritize supplying formula companies. The administration is also airlifting supplies from overseas. 

Just four companies are responsible for 90 percent of the formula market. When Abbott’s plant shut down, the effects cascaded down a supply chain that was already strained because of the pandemic. 

Still, Califf said the FDA had no choice given the conditions found at the plant. 

“We knew that ceasing plant operations would create supply problems, but we had no choice given the insanitary conditions,” Califf said.

But lawmakers expressed frustration that the FDA did not seem to realize the full impact of the recall and plant shutdown. FDA officials told the panel they did not feel a need to warn the public ahead of time because they were concerned about panic buying. 

Abbott’s plant has been shut down since February and has yet to reopen. The FDA has reached a preliminary agreement with Abbott to restart production at the plant, pending safety upgrades and certifications.

In prepared testimony, Califf said numerous setbacks, including a COVID-19 outbreak at the Abbott facility and a whistleblower report that was never seen by agency leadership, contributed to a delay of more than five months from the initial reports of a sick infant to the decision to recall formula.

The FDA first conducted a “routine surveillance inspection” of Abbott’s plant in September 2021 but did not follow up with another inspection until Jan. 31. The recall wasn’t issued until Feb. 17.

A former employee of Abbott sent the FDA a 34-page report in October outlining a host of unsanitary conditions observed at the company’s Michigan plant. 

But top agency officials — including the acting director and the top official in charge of food safety — never saw the report, and nobody at the FDA even requested an interview with the whistleblower until December. 

According to Califf, senior FDA officials eventually received emailed copies of the complaint, but not until February due to “an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues.”

The Washington Post reported Wednesday that Frank Yiannas, the FDA’s deputy commissioner for food policy and response, did not learn about the report until February.

Yiannas confirmed during the hearing he did not see the report until Feb. 10. 

“I’m not sure why the report wasn’t shared with me and how it didn’t get escalated,” Yiannas said.