The first planes carrying baby formula — part of the Biden administration’s newly minted “Operation Fly Formula” — will leave Switzerland for the U.S. in the coming days, giving a dose of good news to parents who hope the shortages end soon. The FDA commissioner says it will be “a few weeks,” though, before supplies of formula are “back to normal.”Following mounting pressure from both sides of the aisle to take action on the worsening formula shortages, President Biden this week invoked the Defense Production Act to speed up baby formula manufacturing in the U.S. He also announced the measure to facilitate faster importation of formula from Europe with DoD-contracted commercial aircraft. The administration announced its first “Operation Fly Formula” mission the next day. The Department of Defense is “actively working the request to identify commercial aircraft” to transport 1.5 million 8-ounce bottles of Nestle-brand hypoallergenic formulas for children with allergies to Illinois from Switzerland, the White House statement said. “These formulas have been prioritized because they serve a critical medical purpose and are in short supply in the United States because of the Abbott Sturgis plant closure.”The Abbott plant in Michigan that closed in February due to a recall produced much of the nation’s supply of specialty formulas for children with health issues.The formula shortages reached a crisis point in recent weeks. Nationwide, 43 percent of baby formula was out of stock in the first week of May, and in several states the out-of-stock rate topped 50 percent, according to retail analytics firm Datasembly. Two babies in Tennessee and “a few” in Atlanta are now hospitalized, according to reports, because their parents couldn’t find required specialty formulas.Commissioner Robert Califf of the FDA testified before a House appropriations subcommittee in a virtual meeting Thursday, telling lawmakers he expects “improvement” within days because of the administration’s actions this week and the preliminary consent decree reached with Abbott to reopen its plant.Dr. Califf was the first administration official to testify before Congress on the formula shortages. When pressed about why the FDA took months before it inspected the Abbott plant after a whistleblower report in October, Dr. Califf said he couldn’t comment further because the investigation “is ongoing,” though he promised to provide more details at a House Oversight Committee hearing next week. He said he expects the Abbott plant to reopen “in the next one to two weeks.”Abbott says it will take between six and eight weeks for its formula to hit store shelves after production resumes.Dr. Califf’s appearance came a day after the House approved a $28 million emergency funding bill for the FDA to address the shortages and hire more personnel. Dr. Califf blamed a lack of inspectors and outdated IT and data collection systems for the agency’s problems. Nearly 200 House Republicans voted against the bill. Minority Whip Steve Scalise criticized it as “throwing additional money at the FDA with no plan to actually fix the problem.”The impending U.S. arrival of the first “Operation Fly Formula” shipments and the reopening of the Abbott plant are welcome news to worried parents. Yet larger systemic issues with the formula market need to be addressed so a crisis like this doesn’t occur in the future, many on the left and right say, though their ideas for solutions may differ.“Funding is not the only answer. This issue goes beyond funding. And that has to do with a structural problem,” Representative Rosa DeLauro, a Democrat, said in Thursday’s House appropriations subcommittee meeting.One major issue is the hold that Abbott and the other three large formula manufacturers have on the U.S. market, accounting for more than 90 percent of sales. Abbott also has the most state contracts with WIC, the supplemental nutrition assistance program that subsidizes nearly 50 percent of U.S. formula sales. The company that holds a state WIC contract benefits from increased store shelf space and hospitals giving out their product to new mothers, who often stick with whichever brand they get. These contracts create and perpetuate market dominance among a select few brands.Another issue is trade barriers such as tariffs and strict regulations on labeling and ingredient requirements, which, combined with WIC’s sole-source contracting, make imported formula less competitive. About 98 percent of U.S. formula is produced domestically, though comparable products are available from Europe, Australia, and Canada. The Biden administration is focusing on increasing formula imports from overseas to meet demand, but only on a temporary basis.Senator Paul introduced legislation Wednesday to “permanently remove tariffs on baby formula” and loosen regulations and labeling requirements for formula imported from “certain countries” with strict safety standards.Abbott’s large market share, combined with supply chain issues, labor shortages, and the fact that the Michigan factory exclusively manufactured many specialty formulas, caused the recall to have an outsized impact. Dr. Califf warns this could happen again: “This crisis has shown us the impact of having a single manufacturer cease production for a brief period. And unless we restructure the resilience of our supply chain, we could be one natural disaster, quality mishap or cyber attack from being here again.”
