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 in the stores.
Califf will detail a series of setbacks that slowed FDA’s response by several months, including a COVID-19 outbreak at the plant and a whistleblower complaint that failed to reach FDA leadership due to a “failure in the mailroom.”
The shortage is largely due to problems at Abbott Nutrition’s Michigan facility, the largest in the US, which the FDA closed 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 learning of potential problems back in September.
Members of an Energy and Commerce subcommittee will also hear from three infant formula manufacturers, including a top Abbott executive.
FDA officials began investigating Abbott’s facility last fall while tracking multiple bacterial infections in infants who had consumed formula from the facility. The four cases occurred between September and January and resulted in hospitalizations and 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 has also been faced with questions about delays in reviewing an October whistleblower complaint alleging numerous safety violations at Abbott’s facility, including the falsification of records by employees. 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.
Senior FDA officials eventually received copies of the complaint via email, but not until February due to “an isolated outage in the FDA mailroom, likely due to COVID-19 staffing issues,” according to the prepared remarks. A letter sent by post to the Commissioner in office at the time, Dr. Copy addressed to Janet Woodcock has still not been found, according to the FDA.
Political anger over the shortage has gone straight to the FDA and Califf, the only government official to testify on the issue so far. The troubles have quickly escalated into a political firestorm for President Joe Biden, who has invoked the Defense Production Act and emergency flights to secure supplies.
Califf will surely wonder why his agency didn’t anticipate the shortage, since Abbott’s plant supplies about a sixth of the US formula supply. FDA regulators did not contact the U.S. Department of Agriculture until February 11 about impacts on the supply of formulas. According to testimony. Califf will argue that his agency does not have the “authority, resources or dedicated staff” to pursue supply chain disruptions. He will ask lawmakers for new powers and resources to monitor the information.
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://abc7.com/baby-formula-shortage-abbott-fda-infant/11893412/ Wording flaw: FDA chief provides details on delays in Abbott plant inspection