FDA concedes delays in response to baby formula shortage

Sep 20, 2022, 2:25 AM | Updated: 3:01 pm
FILE - Similac Alimentum Hypoallergenic Infant Formula, imported from Puerto Rico, is for sale at a...

FILE - Similac Alimentum Hypoallergenic Infant Formula, imported from Puerto Rico, is for sale at a Stew Leonard's grocery store in Yonkers, New York, Friday, June 10, 2022. The FDA acknowledged Tuesday, Sept. 20, that its response to the national shortage of infant formula was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest manufacturing plant. A 10-page report from the agency offers the first formal account of the factors that led to the ongoing infant formula shortage. (AP Photo/Ted Shaffrey, File)

(AP Photo/Ted Shaffrey, File)

WASHINGTON (AP) — The Food and Drug Administration acknowledged Tuesday that its response to the U.S. infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.

A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage, which has forced the U.S. to airlift millions of pounds of powdered formula from overseas.

The review zeroed in on several key problems at the agency, including outdated data-sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

“For things that are critical to the public health, if you don’t have some understanding of how all the pieces fit together, then when you get into a crisis or a shortage you have a real problem,” FDA Commissioner Robert Califf told The Associated Press in an interview. “To a large extent that’s what happened here.”

Califf said the FDA will seek new authority to compel companies to turn over key information.

One consumer advocate said the evaluation doesn’t go far enough to fix the problems.

“This internal evaluation treats the symptoms of the disease rather than offering a cure,” Scott Faber of the Environmental Working Group said in a statement. “Nothing in this evaluation addresses the fragmented leadership structure that led to critical communication failures.”

The FDA report was overseen by a senior official who interviewed dozens of agency staffers. It comes nearly eight months after the FDA shuttered Abbott’s Michigan plant due to safety concerns, quickly slashing domestic production within the highly concentrated formula industry.

A company whistleblower had tried to warn the FDA of problems at the plant in September 2021, but government inspectors didn’t investigate the complaints until February after four infants became sick, resulting in two deaths. The FDA is still investigating links between those illnesses and the formula.

The FDA previously told Congress that top agency officials didn’t learn about the complaint until February because of mail delays and a failure to escalate the Abbott employee’s allegations. The new report stated that FDA’s “inadequate processes and lack of clarity related to whistleblower complaints,” may have delayed getting inspectors to the plant.

“Whistleblower complaints come into the agency in many different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary medicine official who oversaw the review. “One of the actions we’ve already taken is to make sure that however they come into the agency, they get triaged and escalated to the right leadership levels.”

FDA inspectors collected bacterial samples from the plant for testing, but shipping issues by “third party delivery companies” delayed the results, according to the report. The FDA also faced challenges ramping up its testing capacity for cronobacter, a rare but potentially deadly bacteria repeatedly linked to outbreaks in baby formula.

The FDA also noted that it had to reschedule its initial inspection of the Abbott plant due to cases of COVID-19 among company staff. That delay came on top of earlier missed inspections because the agency pulled its inspectors from the field during the pandemic.

The report concluded by listing new resources that Congress would need to authorize to improve infant formula inspections and standards, including:

— Increased funding and hiring authority to recruit experts to FDA’s food division;

— Improved information technology to share data on FDA inspections, consumer complaints and testing results;

— New authority to compel manufacturers to turn over samples and records on manufacturing supply chains, manufacturing quality and safety.

U.S. inventories of baby formula have been improving, hitting in-stock rates above 80% last week, according to IRI, a market research firm. That’s up from a low of 69% in mid-July. The U.S. has imported the equivalent of more than 80 million bottles of formula since May, according to White House figures, and the Biden administration is working to help foreign manufacturers stay on the market long term to diversify supply.

Califf has commissioned a separate external review of FDA’s food division citing “fundamental questions about the structure, function, funding and leadership” of the program. That review is being led by former FDA commissioner Dr. Jane Henney, who led the agency during the final years of the Clinton administration.

___

Follow Matthew Perrone on Twitter: @AP_FDAwriter.

___

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.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

AP

Associated Press

2 South American researchers killed in Missouri

KANSAS CITY, Mo. (AP) — Missouri homicide and arson detectives are investigating the deaths of two South American researchers whose bodies were found after a weekend apartment fire near the Kansas City biomedical research center where they worked. Kansas City police identified the victims as Camila Behrensen, 24, of Buenos Aires, Argentina, and Pablo Guzmán […]
17 hours ago
Associated Press

CEO of election software firm held on ID info theft charges

LOS ANGELES (AP) — The founder and CEO of a software company targeted by election deniers was arrested Tuesday on suspicion of stealing data on Los Angeles County poll workers. Konnech Corporation’s Eugene Yu, 51, was held on suspicion of theft of personal identifying information and computer hard drives. Other “digital evidence” was seized by […]
17 hours ago
Data flash cards sit on certification forms for ballot-counting machines bearing the signature of T...
Associated Press

Rural New Mexico county seeks removal of elections clerk

SANTA FE, N.M. (AP) — A county commission in rural New Mexico that has been roiled by election conspiracies is trying to oust its election director just five weeks before Election Day for improperly certifying ballot-counting equipment. Torrance County is repeating the certification of its vote-counting machines for the Nov. 8 general election based on […]
17 hours ago
FILE - Presidential election campaign flags hang for sale, featuring the faces of both current Pres...
Associated Press

Bolsonaro, Lula fight for endorsements before Brazil runoff

SAO PAULO (AP) — Brazilian President Jair Bolsonaro and former President Luiz Inácio Lula da Silva started bringing centrist allies into their camps Tuesday, two days after voting in Latin America’s biggest democracy sent the rivals to a Oct. 30 runoff. Da Silva, a leftist who is universally known as Lula and was president from […]
17 hours ago
In this photo provided by Johnny Lauder, Lauder takes a selfie with his mother, Karen Lauder, 86, a...
Associated Press

Son’s images show him rescuing Mom from Ian’s floodwaters

In one photo, Johnny Lauder’s 86-year-old mother is in her Florida home, submerged nearly to her shoulders in black murky water, staring straight at the camera, mouth open. In another, she lies just above the waterline on a table, wrapped in sheets to keep warm. In yet another, she’s being pushed through the water in […]
17 hours ago
Family and friends of inmates wait for news of their jailed loved ones after a deadly prison riot i...
Associated Press

Drug capo among 16 dead in bloody Ecuador prison riot

QUITO, Ecuador (AP) — The death toll from a bloody fight among inmates at a prison in central Ecuador rose to 16 Tuesday, and authorities said one of the dead was an alleged drug gang boss who had evaded charges in Peru by faking his death during the pandemic. Officials said the number of wounded […]
17 hours ago

Sponsored Articles

Anacortes Christmas Tree...

Come one, come all! Food, Drink, and Coastal Christmas – Anacortes has it all!

Come celebrate Anacortes’ 11th annual Bier on the Pier! Bier on the Pier takes place on October 7th and 8th and features local ciders, food trucks and live music - not to mention the beautiful views of the Guemes Channel and backdrop of downtown Anacortes.
Swedish Cyberknife Treatment...

The revolutionary treatment of Swedish CyberKnife provides better quality of life for majority of patients

There are a wide variety of treatments options available for men with prostate cancer. One of the most technologically advanced treatment options in the Pacific Northwest is Stereotactic Body Radiation Therapy using the CyberKnife platform at Swedish Medical Center.
Work at Zum Services...

Seattle Public Schools announces three-year contract with Zum

Seattle Public Schools just announced a three-year contract with a brand-new company to the Pacific Northwest to assist with their student transportation: Zum.
Swedish Cyberknife 900x506...

June is Men’s Health Month: Here’s Why It’s Important To Speak About Your Health

According to the Centers for Disease Control and Prevention, men in the United States, on average, die five years earlier than women.
...

Anacortes – A Must Visit Summertime Destination

While Anacortes is certainly on the way to the San Juan Islands (SJI), it is not just a destination to get to the ferry… Anacortes is a destination in and of itself!
...

Ready for your 2022 Alaskan Adventure with Celebrity Cruises?

Celebrity Cruises SPONSORED — A round-trip Alaska cruise from Seattle is an amazing treat for you and a loved one. Not only are you able to see and explore some of the most incredible and visually appealing natural sights on the planet, but you’re also able to relax and re-energize while aboard a luxury cruise […]
FDA concedes delays in response to baby formula shortage