The Food and Drug Administration admitted on Tuesday that processing a whistleblower complaint and test samples from the biggest formula mill in the country caused delays in the agency’s reaction to the U.S. infant formula shortfall.
The agency’s 10-page report provides the first official assessment of the causes of the prolonged shortfall, which required the United States to airlift millions of pounds of powdered formula from abroad.
The evaluation focused on many significant issues within the organization, including out-of-date data-sharing systems, insufficient staffing and training for its food inspectors, and little awareness of infant formula supply chains and production processes.
In an interview, FDA Commissioner Robert Califf said, “For things that are vital to the public health, if you don’t have some understanding of how all the pieces go together, then when you get into a crisis or a shortage, you have a real problem.” “That’s largely what occurred here,” the speaker said.
According to Califf, the FDA will seek new legal authorities to compel businesses to disclose crucial information.
According to a consumer advocate, the evaluation doesn’t go far enough to address the issues.
In a statement, Scott Faber of the Environmental Working Group argued that instead of providing treatment, “this internal review treats the symptoms of the sickness.” Nothing in this study takes into account the disjointed leadership structure that caused severe communication breakdowns.
A senior official who oversaw the FDA report spoke with numerous employees of the organization. In response to safety concerns, the FDA shut down Abbott’s Michigan plant eight months ago, drastically reducing American manufacturing in the highly concentrated formula sector.
In September 2021, a company whistleblower attempted to alert the FDA to issues at the factory. Still, investigators from the government didn’t look into the accusations until February, after four newborns were ill and two died. The FDA is still looking into any connections between those diseases and the recipe.
Before this, the FDA had previously informed Congress that due to mail delays and a failure to escalate the claims made by the Abbott employee, top agency officials were unaware of the complaint until February. The FDA’s “inadequate practices and lack of clarity relating to whistleblower reports,” according to the latest report, may have caused a delay in sending inspectors to the plant.
According to Dr. Steven Solomon, an FDA official in charge of veterinary medicine, “whistleblower complaints come into the agency in many different ways, from many different sources.” Ensuring that they are prioritized and escalated to the appropriate leadership levels, regardless of how they enter the agency, is one of the initiatives we’ve already taken.
FDA inspectors obtained bacterial samples from the facility for testing, but the report claims that “third party delivery providers” had shipping problems that caused the results to be delayed. The FDA had difficulties expanding its testing capabilities for cronobacter, a rare but dangerous bacterium that has been consistently connected to outbreaks in infant formula.
The FDA also mentioned that occurrences of COVID-19 among firm employees necessitated rescheduling its first inspection of the Abbott facility. Because the FDA removed its inspectors from the field during the epidemic, this delay was added to earlier missed inspections.
According to IRI, a market research company, baby formula inventories in the United States have been increasing, reaching in-stock rates exceeding 80% last week. It has increased since a low of 69% in mid-July. According to White House statistics, the United States has imported more than 80 million bottles of infant formula since May. To diversify the supply, the Biden administration strives to assist foreign manufacturers in remaining competitive over the long term.
According to Califf, there are “basic questions about the structure, function, funding, and leadership” of the program, which is why it has requested a separate external examination of the FDA’s food division. Dr. Jane Henney, a former FDA commissioner who oversaw the organization in the closing years of the Clinton administration, is in charge of that review.
The report’s conclusion included a list of new funding sources that Congress would need to approve to raise the standards and inspections for infant formula, including:
- More money and hiring power to hire specialists for the FDA’s food division;
- Enhanced IT to communicate information on FDA inspections, customer concerns, and test results;
- New power requires manufacturers to provide samples and data about their supply chains, quality control, and safety.