NATIONAL NEWS

FDA chief: COVID, mail mix-up delayed action on baby formula

May 25, 2022, 10:16 AM | Updated: Jun 25, 2022, 8:55 pm

Baby formula is offered for sale at a big box store on January 13, 2022 in Chicago, Illinois. Baby ...

Baby formula is offered for sale at a big box store on January 13, 2022 in Chicago, Illinois. Baby formula has been is short supply in many stores around the country for several months. (Photo by Scott Olson/Getty Images)

(Photo by Scott Olson/Getty Images)

WASHINGTON (AP) — The head of the Food and Drug Administration said Wednesday that efforts to investigate problems at a baby formula plant linked to the nationwide shortage were slowed by COVID-19, scheduling conflicts and even a missing piece of mail.

FDA Commissioner Robert Califf laid out a series of setbacks in congressional testimony that slowed his agency’s response by months, including a whistleblower complaint that didn’t reach FDA leadership due to a “mailroom failure.”

Califf testified before a House subcommittee probing the shortage, which has forced the U.S. to begin airlifting products from Europe while many parents still hunt for scarce supplies in stores.

Califf told lawmakers FDA’s response was: “Too slow and there were decisions that were suboptimal along the way.”

The FDA and President Joe Biden face mounting pollical pressure to explain why they didn’t intervene earlier to try and address the supply problems. The oversight subcommittee’s ranking Republican quickly zeroed in on the slow response.

“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?” asked Rep. Morgan Griffith, R-Virginia. The panel will also hear from three formula manufacturers, including Abbott Nutrition.

The shortage mostly stems from Abbott’s Michigan plant, the largest in the U.S., which the FDA shut down in February due to contamination.

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

Califf gave the first detailed account of why his agency took months to inspect the plant despite learning of potential problems as early as September.

FDA staff began honing in on Abbott’s plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. The four cases occurred between September and January, leading to hospitalization and two deaths.

Califf told lawmakers the FDA began planning to visit the Sturgis, Michigan, plant in early December, with inspectors set to arrive on Dec. 30. But Abbott said that about a dozen of its employees had recently tested positive for COVID-19 and requested a delay. As a result, the FDA didn’t begin its inspection until Jan. 31.

After detecting positive samples of bacteria in multiple parts of the plant, the FDA closed the facility and Abbott announced a massive recall of its formula on Feb. 17.

Abbott and the FDA have reached an agreement to reopen the plant next week, requiring the company to regularly undergo outside safety audits.

Califf also laid out the agency’s months-long timeline responding to an October whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records.

Several FDA staffers reviewed the complaint in late October, but officials didn’t request an interview until early December. Because of conflicts with the whistleblower’s schedule, the interview didn’t take place until Dec. 22, according to the FDA testimony.

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,” according to the prepared remarks. A mailed copy addressed to then-acting commissioner Dr. Janet Woodcock has still not been located, according to the FDA.

Political fury over the shortage has landed squarely on the FDA and Califf, the only administration official who has testified thus far on the issue. The problems have quickly snowballed into a political firestorm for President Joe Biden, who has invoked the Defense Production Act and emergency flights to shore up supplies.

Califf is also facing questions about why his agency didn’t anticipate the shortage, given that Abbott’s plant supplies roughly one-sixth of the U.S. formula supply. FDA regulators did not contact the U.S. Department of Agriculture about impacts to the formula supply until Feb. 11. Califf’s testimony states that his agency does not have the “authority, resources, or dedicated staff” to track supply chain disruptions. He asked lawmakers for new powers and resources to monitor the information.

Behind the shortage are other distinct factors, including industry consolidation that’s made the U.S. formula market vulnerable to disruptions at individual companies.

An Abbott executive is expected to tell the committee that his company will invest in additional capacity and supply chain safeguards. After the company restarts production next month it will be able to produce more formula than before the recall, according to prepared remarks from Abbott’s senior vice president, Christopher Calamari.

The company will restate its contention that there is no direct link between its formula and the infant infections investigated by the FDA. Agency regulators have said the small number of cases and incomplete testing data make it hard to draw a direct connection between the illnesses and Abbott’s plant.

Executives from Reckitt and Gerber are also scheduled to testify.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

KSL 5 TV Live

National News

Sandra Young went missing from the Portland metro area more than five decades ago. (Oregon State Po...

Dalia Faheid, CNN

Remains of Oregon teenager are identified 50 years later after someone uploaded their DNA into genealogy site

The remains of a Portland, Oregon, teenager who vanished in the late 1960s have been identified through advanced DNA testing more than 50 years after she went missing, authorities said

1 hour ago

FILE - The company logo hangs over the door to an AT&T store Thursday, Feb. 22, 2024, in Denver...

Associated Press

AT&T will give $5 to customers hit by cellphone network outage

AT&T says it will give affected customers $5 each to compensate for last week's cellphone network outage that left many without service for hours.

2 hours ago

Kathy Brandel and Ralph Hendry, from Virginia, were spending the winter cruising the Eastern Caribb...

Sharif Paget, Chris Boyette and Polo Sandoval, CNN

2 Americans believed dead after yacht allegedly hijacked in Grenada

The family of two Americans who may have been killed after prison escapees allegedly hijacked their yacht in Granada are clinging to hope the couple might be found alive.

4 hours ago

A paddle boarder tows an inflatable unicorn on a temporary lake in Death Valley on Thursday, Feb. 2...

Ty O'Neil, John Locher and Stephanie Dazio, The Associated Press

Kayakers paddle in Death Valley after rains replenish lake in one of Earth’s driest spots

Kayakers have been paddling in one of the driest places on Earth after a series of record rainstorms battered California’s Death Valley and replenished Lake Manly.

4 hours ago

Kingsley Ben-Adir, izquierda, protagonista de "Bob Marley: One Love" posa con el hijo de Marley, Zi...

Jonathan Landrum, Jr., The Associated Press

‘One Love’ receives more love at the box office, claiming No. 1 spot for second straight week

For a second straight week, biopic “ Bob Marley: One Love ” continues to exceed expectations by claiming the No. 1 spot at the box office, overcoming two debut films and Sony's “Madame Web” that's still producing subpar numbers.

5 hours ago

February, 29, otherwise know as leap year day, is shown on a calendar Sunday, Feb. 25, 2024, in Ove...

Leanne Italie, The Associated Press

What would happen without a leap day? More than you might think

Leap year. It's a delight for the calendar and math nerds among us. So how did it all begin and why?

6 hours ago

Sponsored Articles

Modern chandelier hanging from a white slanted ceiling with windows in the backgruond...

Lighting Design

Light Up Your Home With These Top Lighting Trends for 2024

Check out the latest lighting design trends for 2024 and tips on how you can incorporate them into your home.

Technician woman fixing hardware of desktop computer. Close up....

PC Laptops

Tips for Hassle-Free Computer Repairs

Experiencing a glitch in your computer can be frustrating, but with these tips you can have your computer repaired without the stress.

Close up of finger on keyboard button with number 11 logo...

PC Laptops

7 Reasons Why You Should Upgrade Your Laptop to Windows 11

Explore the benefits of upgrading to Windows 11 for a smoother, more secure, and feature-packed computing experience.

Stylish room interior with beautiful Christmas tree and decorative fireplace...

Lighting Design

Create a Festive Home with Our Easy-to-Follow Holiday Prep Guide

Get ready for festive celebrations! Discover expert tips to prepare your home for the holidays, creating a warm and welcoming atmosphere for unforgettable moments.

Battery low message on mobile device screen. Internet and technology concept...

PC Laptops

9 Tips to Get More Power Out of Your Laptop Battery

Get more power out of your laptop battery and help it last longer by implementing some of these tips from our guide.

Users display warnings about the use of artificial intelligence (AI), access to malicious software ...

Les Olson

How to Stay Safe from Cybersecurity Threats

Read our tips for reading for how to respond to rising cybersecurity threats in 2023 and beyond to keep yourself and your company safe.

FDA chief: COVID, mail mix-up delayed action on baby formula