Mountain Media, LLC
  • West Virginia News
    • Around The State
    • By Paper
      • Mountain Messenger
      • Pocahontas Times
      • Parsons Advocate
      • Pendleton Times
      • Clay County Free Press
      • Calhoun Chronicle
      • Shinnston News
    • By County
      • Greenbrier County
      • Clay County
      • Harrison County
      • Calhoun County
      • Pocahontas County
      • Pendleton County
      • Tucker County
  • Virginia Media, INC
    • Around The State
    • By Paper
      • The Enterprise
      • Fincastle Herald
      • Henry County Enterprise
      • News Messenger
      • News Journal
      • Vinton Messenger
      • New Castle Record
      • Salem Times Register
    • By County/City
      • Botetourt County
      • Henry County
      • Radford
      • Christiansburg/Blacksburg
      • Patrick County
      • Vinton
      • Roanoke
      • Salem
      • Craig County
  • National News
  • About Us
  • Submit Content
  • Contact Us
  • Classifieds
  • Login
  • My account
Subscribe For $2.50/Month
No Result
View All Result
MM, LLC
  • West Virginia News
    • Around The State
    • By Paper
      • Mountain Messenger
      • Pocahontas Times
      • Parsons Advocate
      • Pendleton Times
      • Clay County Free Press
      • Calhoun Chronicle
      • Shinnston News
    • By County
      • Greenbrier County
      • Clay County
      • Harrison County
      • Calhoun County
      • Pocahontas County
      • Pendleton County
      • Tucker County
  • Virginia Media, INC
    • Around The State
    • By Paper
      • The Enterprise
      • Fincastle Herald
      • Henry County Enterprise
      • News Messenger
      • News Journal
      • Vinton Messenger
      • New Castle Record
      • Salem Times Register
    • By County/City
      • Botetourt County
      • Henry County
      • Radford
      • Christiansburg/Blacksburg
      • Patrick County
      • Vinton
      • Roanoke
      • Salem
      • Craig County
  • National News
  • About Us
  • Submit Content
  • Contact Us
  • Classifieds
  • Login
  • My account
No Result
View All Result
Mountain Media, LLC
  • Virginia News
  • West Virginia News
  • National News
  • Login
  • My account
  • Subscribe
Home Local National News

FDA concedes delays in response to baby formula shortage

September 22, 2022
in National News
Reading Time: 3 mins read
Share on FacebookShare on Twitter

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.

ShareTweetShare

Related Posts

US adds a surprisingly strong 517,000 jobs despite Fed hikes

February 3, 2023

WASHINGTON (AP) — America’s employers added a sizzling 517,000 jobs in January, a surprisingly strong gain in the face of the...

Blinken postpones China trip following balloon discovery

February 3, 2023

WASHINGTON (AP) — Secretary of State Antony Blinken has postponed a planned high-stakes weekend diplomatic trip to China as the...

Ford returns to Formula One in partnership with Red Bull

February 3, 2023

Ford will return to Formula One as the engine provider for Red Bull Racing in a partnership announced Friday that...

In Mexico, worry that Maya Train will destroy jungle

February 3, 2023

CALAKMUL BIOSPHERE RESERVE, Mexico (AP) — Miguel Ángel Díaz walks slowly so his footfall on dry leaves doesn’t drive away...

US, Philippines agree to larger American military presence

February 2, 2023

MANILA, Philippines (AP) — The United States and the Philippines on Thursday announced plans to expand America's military presence in...

Fed lifts rate by quarter-point but says inflation is easing

February 2, 2023

WASHINGTON (AP) — The Federal Reserve extended its fight against high inflation Wednesday by raising its key interest rate a...

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

  • My account
  • Subscribe
  • Classifieds
Call us: +1 234 JEG THEME

© 2021 Mountain Media, LLC

No Result
View All Result
  • Login
  • Sign Up
  • Cart
  • West Virginia News
    • Around The State
    • By Paper
      • Mountain Messenger
      • Pocahontas Times
      • Parsons Advocate
      • Pendleton Times
      • Clay County Free Press
      • Calhoun Chronicle
      • Shinnston News
    • By County
      • Greenbrier County
      • Clay County
      • Harrison County
      • Calhoun County
      • Pocahontas County
      • Pendleton County
      • Tucker County
  • Virginia Media, INC
    • Around The State
    • By Paper
      • The Enterprise
      • Fincastle Herald
      • Henry County Enterprise
      • News Messenger
      • News Journal
      • Vinton Messenger
      • New Castle Record
      • Salem Times Register
    • By County/City
      • Botetourt County
      • Henry County
      • Radford
      • Christiansburg/Blacksburg
      • Patrick County
      • Vinton
      • Roanoke
      • Salem
      • Craig County
  • National News
  • About Us
  • Submit Content
  • Contact Us
  • Classifieds
  • Login
  • My account

© 2021 Mountain Media, LLC

Welcome Back!

Login to your account below

Forgotten Password? Sign Up

Create New Account!

Fill the forms below to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In
  • Sign in
  • New account

Forgot your password?

Lost your password? Please enter your email address. You will receive mail with link to set new password.

Back to login