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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zeroed in on several key problems at the agency, including outdated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.