By Victor Reklaitis
FDA commissioner says his agency was 'too slow' and Abbott's plant had 'egregiously unsanitary conditions'
Working to address a nationwide baby-formula shortage, Democratic and Republican lawmakers on Wednesday put a spotlight on makers of the formula, the Biden administration and outside experts, as two House hearings focused on the ongoing lack of supply.
"We expect answers from the FDA, Abbott and the other two leading formula manufacturers on why caregivers are scrambling to find the necessary nutrition that they need to sustain their babies and children," said Democratic Rep. Diana DeGette of Colorado, who chairs the House Energy and Commerce Committee's oversight subcommittee, as she kicked off that panel's hearing.
The Food and Drug Administration's commissioner, Dr. Robert Califf, testified before DeGette's subcommittee, and executives from Abbott (ABT), Nestle's (NESN.EB) Gerber business and Reckitt (RKT.LN) appeared as witnesses later.
"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 was hosted by the House Appropriations Committee's agriculture subcommittee, and it featured experts on formula, as well as a mother and grocery-store manager.
The hearings have come as Washington continues to react to the infant-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 the FDA'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 in February 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 FDA closed the plant in February, and the agency and Abbott recently reached an agreement to reopen the plant next week.
Abbott has apologized for its role in the nationwide shortage of baby formula. In its prepared testimony for Wednesday, the company reiterated its contention that there is no direct link between its formula and the four infant infections investigated by the FDA, two of which led to death.
"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.
Republican Rep. Cathy McMorris Rodgers of Washington state asked Abbott's exec how he could "give us confidence that Abbott is going to address the underlying causes of continued compliance problems?"
"We are aligned as leaders to make sure we put the necessary steps and sustained actions in place so that this doesn't happen again," responded Christopher Calamari, a senior vice president at Abbott.
At the House Appropriations subcommittee's hearing, a nutrition expert from Memphis, Tenn., talked about the toll on parents and other caregivers.
"Recently in Memphis, two children were admitted to our local pediatric hospital with dehydration caused by intolerance to the formula which had been substituted for their regular specialized formula. Caregivers are at their wit's end and feel that they must find something to feed their children," said Ginger Carney,director of clinical nutrition and lactation services at St. Jude Children's Research Hospital.
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.
(END) Dow Jones Newswires
05-25-22 1558ETCopyright (c) 2022 Dow Jones & Company, Inc.