USA 2020 Elections: Thread

grarpamp grarpamp at
Thu May 26 15:08:07 PDT 2022

Biden admin knew all about Govt baby formula shutdown,
tries to claim Govt created monopolies are not to blame...

"Too Slow": FDA Admits Delayed Response To Complaints About US Baby
Formula Plant

The U.S. Food and Drug Administration’s (FDA) initial response to
complaints about Abbott’s infant formula plant was “too slow” and some
decisions could have been “more optimal,” the FDA’s top official said
while facing a grilling from lawmakers on Wednesday.

FDA Commissioner Dr. Robert Califf appeared before a congressional
panel to answer questions about the FDA’s handling of events that led
to the biggest infant formula shortage in recent U.S. history after
Abbott in February recalled some products and closed its Sturgis
manufacturing plant.

Rep. Diana DeGette (D-Colo.), chair of the panel, raised the question
of the “timeline of FDA’s investigation and response,” citing a
“four-month lapse before returning to inspect the Sturgis facility,”
and a delay in contacting a former Abbott employee whistleblower.

Lawmakers heard that senior FDA officials only saw the complaint in
February because of pandemic-related mail routing issues.

Califf acknowledged that the “FDA’s timeliness of interviewing the
whistleblower and getting into the facility for a for-cause inspection
were too slow. And some decisions in retrospect could have been more

    “While there are many steps along the way where different actions
could have sped up the sequence of events, to this day, I can find no
evidence of intentional delay or malfeasance,” he said.

The FDA inspected the plant following reports of bacterial infections
in babies allegedly linked to Abbott’s formula, and the whistleblower
complaint in late October.

But an investigation by the FDA and the U.S. Centers for Disease
Control and Prevention “could not conclude” that the “egregiously
unsanitary conditions” at the Abbott plant caused the illnesses in the

    “However, we cannot rule it out either. There’s a confluence of
events that’s highly unusual. There is no dispute that the facility
was unacceptably unsanitary, as evidenced by the consent decree.
Frankly, the inspection results were shocking,” he said.

Califf noted that inspectors found cracks in vital equipment, a lack
of adequate handwashing, evidence of previous bacterial contamination,
and water leaks in areas where formula is produced, a risk factor for

It is critical to return the Sturgis plant to safe production of
infant formula as soon as possible, Califf said, because Abbott holds
the largest market share in America, “leaving it with a
responsibility” to produce safe formula “that was not met.”

Abbott did not have a contingency plan to produce its lines of
specialty formulas that serve as the only source of nutrition for
thousands of babies with metabolic disorders, lawmakers heard.

    “We will do everything in our power to work with Abbott to make
this happen as quickly and safely as possible. But this timing is in
Abbott’s control,” Califf said.

Reflecting on the FDA’s role in exacerbating the formula shortage,
Califf cited chronic underfunding of the FDA as one issue that needs
to be addressed, hinting that “you will see changes in the future.”

    “Our requests for funding and authority are essential in concert
with improved operations and leadership,” he said.

For the sake of expediency, the FDA entered a consent decree with
Abbott, which allows the company to avoid litigation by pledging to
voluntary act to improve and address deficiencies. An outside official
will have full oversight of “every single step.”

Abbott said on Tuesday that it planned to reopen the plant on June 4.

Meanwhile, the Federal Trade Commission (FTC) on Tuesday launched an
inquiry into the ongoing shortage of formula.

In a statement, the FTC said the inquiry seeks information on the
“nature and prevalence of any deceptive, fraudulent, or otherwise
unfair business practices aimed at taking advantage of families during
this shortage.”

The inquiry also seeks to find out what factors “have led to
concentration in the infant formula market and the fragility of the
supply chains for these crucial products,” the FTC said.

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