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Opinion The FDA must be held to account for the baby formula crisis

Shelves normally full of baby formula sit empty at a store in D.C. on Sunday. (Samuel Corum/AFP/Getty Images)

The baby formula debacle has taught the nation many lessons. Among the most important is how the Food and Drug Administration failed. The agency did an insufficient job inspecting and monitoring formula factories. It reacted sluggishly to a whistleblower and to reports of sick infants. And it neglected to take timely action to prevent the shortage after a major production plant closed in February.

The timeline tells the story: Last September, the FDA made its first visit to Abbott’s Sturgis, Mich., baby formula plant during the pandemic and concluded the facility was not “in a clean and sanitary condition.” Around then, the Minnesota Department of Health alerted the FDA to a sick infant who consumed formula from the Sturgis plant. In October, a whistleblower sent the FDA a 34-page document alleging falsifying of records and uncleanliness at the Sturgis plant. (The agency says a “failure in FDA’s mailroom” prevented top officials from seeing it for months.) More reports of sick babies arrived on Dec. 1 and Jan. 11. But the FDA didn’t investigate the plant again until Jan. 31, which is when it found evidence of a bacteria deadly to infants. Abbott shut down the plant and issued a voluntary recall in mid-February — five months after the initial red flags.

Four suppliers control almost all of the U.S. baby formula market. The massive drop in availability of Abbott formula quickly led to a nationwide shortage, a situation the FDA should have seen coming. But not until mid-May did the agency announce it would streamline the onerous process for importing supplies from abroad. (Formula is finally arriving from Europe with more expected from Britain in early June.)

The FDA needs an urgent overhaul of its food safety division. In an extensive Politico report last month, former acting FDA commissioner Stephen Ostroff put it bluntly: “The food program is on the back burner. To me, that’s problem No. 1.” FDA food investigations peaked in 2011 at 10,641 and have been falling ever since. Beefing up inspections, staffing and oversight must be a priority for FDA Commissioner Robert M. Califf, who received a blistering grilling Wednesday on Capitol Hill.

Congress must also do its part to boost funding and give the FDA clear oversight authority, including requiring companies to report potential supply problems. House Appropriations Committee Chairwoman Rosa L. DeLauro (D-Conn.) deserves credit for flagging FDA problems, including the troubling lack of inspections, for years. The agency only has nine full-time staff who review baby formula reports. There are a handful of on-the-ground inspectors, but only one specializes in infant formula manufacturing. This is inadequate and highlights how wrong it was for 192 House Republicans to vote against giving the FDA a mere $28 million in additional funding.

Abbott is also at fault. While the company likes to point out that the bacteria found at the plant did not match the exact illness the infants had, it’s clear there were major problems at the Sturgis facility. Abbott leadership needs to do more than say “we’re sorry.” More testing at the facility is the minimum needed.

Many failures led to this crisis, and the pandemic exacerbated them. But when the FDA is not looking carefully, there are serious and deadly consequences.

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