Federal plans to inspect a baby formula factory related to the statewide shortage have been slowed by COVID-19, scheduling conflicts and other logistical issues, according to prepared testimony from the head of the Food and Drug Administration.
FDA Commissioner Robert Califf on Wednesday will answer questions from House lawmakers investigating the events leading up to the milk formula shortages that have forced the U.S. to start airlifting produce from Europe, while many parents are still look for scarce supplies.
The problem is largely related to problems at Abbott Nutrition’s Michigan factory, the largest in the US, which the FDA shut down in February due to contamination. In prepared remarks, Califf gives the first detailed account of why it took his agency months to inspect the facility after first learning of potential problems last fall.
Members of an Energy and Commerce subcommittee will also hear from three infant formula manufacturers, including a top Abbott executive.
FDA officials began looking into problems at Abbott’s facility after tracking four bacterial infections in infants who consumed formula from the facility. The cases emerged between September and January and caused four hospitalizations, including two deaths.
Califf will tell lawmakers that the FDA began planning to visit the Sturgis, Michigan plant in early December, with inspectors scheduled to arrive Dec. 30. However, Abbott said about a dozen of its employees had recently tested positive for COVID-19 and requested a delay. As a result, the FDA did not begin its inspection until January 31st.
After detecting positive bacterial samples in several parts of the facility, the FDA closed the facility and Abbott announced a massive recall of its formula on February 17.
Abbott and the FDA have reached an agreement to reopen the facility next week, requiring the company to undergo regular external safety audits. However, Califf’s testimony suggests FDA efforts to reopen the facility were slowed by negotiations with Abbott that needed to be written into a court settlement.
“Because this was a negotiation process with a regulated entity, the U.S. government did not have full control over the timing,” Califf’s written statement said.
The FDA was also faced with questions about its timeline for reviewing an October whistleblower complaint alleging numerous safety violations at Abbott’s facility, including falsifying records by employees and failing to test the formula. Califf’s testimony describes a two-month gap between regulators receiving the report and actually interviewing the whistleblower.
Several FDA employees reviewed the complaint in late October, but officials didn’t request an interview until early December. Due to conflicts with the whistleblower’s schedule, the interview did not take place until December 22, according to the FDA.
According to the prepared remarks, senior FDA officials only received copies of the whistleblower’s complaint in February about “an isolated outage in the FDA’s mailroom, likely due to staffing issues related to COVID-19.”
Califf is the only government official to testify so far about the shortage, which has become a major political burden for President Joe Biden. Other disparate factors are behind the shortage, including supply disruptions from COVID-19 and an industry consolidation that has left the US formula market vulnerable to disruption.
An Abbott executive is expected to tell the committee that his company will invest in additional capacity and supply chain safeguards to avoid future disruptions. After production resumes next month, the company will be able to produce more formula than before the recall, according to prepared comments from Abbott’s senior vice president, Christopher Calamari.
The company will reiterate its claim that there is no direct link between its formula and the infant infections that the FDA is investigating. Agency regulators have said the small number of cases and incomplete testing data make it difficult to establish a direct link between the diseases and Abbott’s facility.
Reckitt and Gerber executives are also scheduled to testify.
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https://www.independent.co.uk/news/fda-ap-covid-washington-europe-b2086718.html FDA chief explains delays in baby formula factory inspection