House lawmakers take on baby-formula shortage: ‘We expect answers from the FDA, Abbott’

The Food and Drug Administration’s commissioner, Dr. Robert Califf, testified before DeGette’s subcommittee, with representatives from Abbott
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Gerber business and Reckitt
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slated to appear as witnesses later in the day.

“The big question I have today is why did the Biden administration let the shortage become so dire before acting with any urgency,” said the subcommittee’s top Republican, Rep. Morgan Griffith of Virginia.

A second hearing on the formula shortage is scheduled to start around 2 p.m. Eastern Wednesday, hosted by the House Appropriations Committee’s agriculture subcommittee and featuring experts on formula.

The hearings have come as Washington continues to react to the ongoing, nationwide baby-formula shortage. Last week, the Democratic-led House approved two bills addressing the issue, while Republicans characterized the other party’s approach as “throwing money at the same bureaucrats who caused the crisis.”

The Biden administration has taken steps that include military airlifts from Europe of formula and invoking the Defense Production Act to boost supplies. The Federal Trade Commission on Tuesday announced that it has launched an inquiry into the shortage, seeking information about any unfair business practices and about the factors that have led to concentration in the formula market and fragile supply chains.

Critics of the administration contend that the U.S. should “focus on the root causes of the U.S. not importing more high-quality formula from Europe, including high tariffs and stringent FDA importation requirements, particularly around labeling,” said Kim Monk, a healthcare analyst and managing director at Capital Alpha Partners, in a note.

“The formula shortage is complex, involving trade policy, state-based monopoly contracts with the USDA’s WIC program, and FDA’s stringent import/labeling requirements as well,” she also wrote, referring to the Department of Agriculture’s Special Supplemental Nutrition Program for Women, Infants and Children.

“But first, lawmakers want some answers as to why it took FDA four months to respond to a whistleblower complaint about safety problems at Abbott Nutrition’s Michigan factory.”

In his testimony on Wednesday before the House Energy and Commerce subcommittee, the FDA’s Califf gave the first detailed account of why his agency took months to inspect the plant despite learning of potential problems as early as September.

Califf had faced a bipartisan grilling in a separate House hearing last week, saying he couldn’t share details due to his agency’s ongoing investigation, but his agency then offered a timeline of its moves on Wednesday.

The timeline from the FDA said the agency’s staff began planning in October to inspect an Abbott formula plant in Sturgis, Mich., after receiving a whistleblower complaint, but agency leadership did not receive “direct copies of the complaint due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues.”

The FDA’s timeline also said it asked to interview the whistleblower on Dec. 7, but “due to scheduling limitations associated with the informant, the interview was not scheduled until 22 December.” In addition, the agency said it wanted to inspect Abbott’s Sturgis facility on Jan. 3, but due to COVID cases among Abbott staff the inspections didn’t happen until Jan. 31 to March 18.

“FDA’s timeliness of interviewing the whistleblower and getting into the facility for a for-cause inspection were too slow and some decisions in retrospect could have been more optimal,” Califf said.

Abbott ended up voluntarily recalling some of its formulas manufactured in its Sturgis plant after FDA officials found a potentially deadly bacteria there, in a move that exacerbated existing shortages created by supply-chain problems during the COVID-19 pandemic.

The company has apologized for its role in the nationwide shortage of baby formula. According to its prepared testimony for Wednesday, the company is expected to restate its contention that there is no direct link between its formula and the infant infections investigated by the FDA.

“The FDA and CDC’s investigation could not conclude that the egregiously unsanitary conditions in the Abbott facility caused the illnesses reported on the timeline. However, we cannot rule it out either,” Califf told lawmakers.

Republicans have blasted the Biden administration repeatedly for the formula shortage, and the criticisms are likely to continue as the GOP aims to take back the House and Senate in November’s midterm elections.

Now read: Experts suggest using WIC government benefits to get baby formula amid a nationwide shortage — but these frustrated parents say that’s not a viable option

The Associated Press contributed to this report.