FDA chief struggles to explain its slow response on baby formula

The head of the Food and Drug Administration was met with bipartisan rage by Parliament’s lawmakers on Wednesday over months of delays in investigating problems at the country’s largest baby milk substitute factory that led to a ongoing shortage.

FDA Commissioner Robert Califf described a series of setbacks in congressional testimony that delayed his agency’s response, including an outbreak of covid-19 at the facility and a complaint from a whistleblower who did not reach FDA management because it apparently disappeared by mail.

Califf testified before a subcommittee in Parliament investigating the shortage, which has plunged into a national crisis and forced the US military to air transport to the USA from Europe.

The shortage is largely due to Abbott’s plant in Michigan, which the FDA closed in February due to pollution problems. Under fire from Congress, parents and the media, Califf gave the first detailed account on Wednesday of why his agency took months to inspect and close the facility despite finding out about potential problems as early as September.

The FDA response was “too slow”

The FDA’s response was “too slow, and there were suboptimal decisions along the way,” Califf told lawmakers.

FDA and President Joe Biden are both facing increasing pressure to explain why they did not intervene earlier to avert the supply crisis.

“Why was an onslaught of national media attention required for the Biden administration to act with a sense of urgency required to address the shortage of infant formula?” asked Representative Morgan Griffith, R-Virginia, the committee’s ranked Republican.

Califf said the agency had been trying to monitor prescription supply since 2020 when covid-related disruptions first occurred, but regulators have limited transparency in the company’s supply chains.

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The house panel also heard from three formula manufacturers, including a senior Abbott Nutrition manager who apologized to parents for the shortage.

“We betray you,” said Abbott Vice President Christopher Calamari. “We are deeply saddened.”

Calamari repeatedly circumvented questions about whether any employees were disciplined or laid off due to problems at the facility, which included standing water, a leaking roof and damaged equipment.

Dangerous bacteria

FDA staff began refining Abbott’s facility last fall while detecting several bacterial infections in infants who had consumed infant formula from the facility. The four cases occurred between September and January and caused hospitalizations and two deaths.

The FDA planned to begin inspecting the facility in Sturgis, Michigan, on December 30, according to Califf’s testimony. But Abbott warned that dozens of factory workers had tested positive for covid-19 and demanded a delay. As a result, the FDA did not begin its inspection until January 31.

After discovering positive samples of a rare but dangerous bacterium in several parts of the plant, the FDA closed the plant and Abbott announced a massive recall of its formula on February 17.

“We knew that stopping the construction business would create supply problems, but we had no choice given the insanity conditions,” Califf said, calling the problems “shocking” and “unacceptable.”

Abbott and the FDA have reached an agreement to reopen the facility next week, according to which the company must regularly undergo external safety audits.

Employees forged records

Califf also struggled to explain delays in the follow-up to a whistleblower complaint alleging numerous security breaches at Abbott’s plant, including employees who falsified records and failed to test the formula before delivery.

Several FDA employees reviewed the complaint in late October when it was sent to a regional FDA office, but an interview did not take place until two months later, in part due to the whistleblower’s scheduling conflicts.

Senior FDA officials eventually received the complaint via email, but not until February because of “an isolated error in the FDA’s mailroom, probably due to staffing issues with covid-19,” according to FDA testimony. A posted copy addressed to the then acting commissioner Dr. Janet Woodcock has still not been found.

Political outrage over the shortage has landed directly on the FDA and Califf, who were confirmed for the FDA role for the second time in February. The problems have escalated into a political firestorm for the White House, which has invoked the law on defense production and emergency import measures.

The FDA contacted the US Department of Agriculture on February 11 about a potential deficiency, just days before Abbott’s recall, according to the FDA’s timeline.

Concern for food

Califf said the FDA requested new authorities, funding and personnel to track data from the supply chain that could have helped get rid of the problem, but noted that Congress has not provided them.

Several lawmakers have raised long-standing concerns that the FDA’s food program – which monitors most US foods other than meat, poultry and eggs – is underfunded and needs to be restructured.

The program has an intricate leadership structure where there is a director of the FDA’s Center for Food Safety and Applied Nutrition and a separate deputy commissioner for “food policy and response.” The Deputy Commissioner has a more security focus, but has no direct authority over food center staff or field staff inspecting the company’s plants.

Both officials testified on Wednesday, along with Califf.

The report claims that FDA leadership is failing to ensure food safety


When rep. Nanette Diaz-Barragan, D-Calif., Asked who is responsible for food safety, gave Califf and Food Center Director Susan Mayne extended answers, and described different roles and responsibilities.

“I do not think there is a person responsible,” Diaz-Barragan replied. “I just think it shows that there needs to be restructuring and it needs to be clearer who is ultimately responsible.”

Later Wednesday afternoon, Abbott’s Calamari lawmaker said his company plans to build up extra capacity and layoffs in its supply chain to avoid future disruptions. He reiterated the company’s point that the FDA has not drawn a direct link between the diseases reported in infants and bacterial samples collected from its facility.

After the company restarts production next month, it will be able to produce more formula than before the recall, he noted.

“We will learn from this. We will get better as a result,” Calamari said.

Managers from Reckitt and Gerber also testified about their efforts to increase production.

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