Thursday, May 19, 2022

Formula roundup: House passes bills to help FDA, expand WIC choices; Biden invokes Defense powers; plant could reopen soon; some infants and children hospitalized

Here are some significant new developments in the baby formula shortage:

Abbott Laboratories reached an agreement Monday to reopen its Sturgis, Michigan plant in the next few weeks, pending federal inspectors' approval. Today Food and Drug Administration commissioner Robert M. Califf told a House appropriations subcommittee that he expects the plant to be open again within two weeks, and begged for more funding so the agency can cope with its workload, Laura Reiley reports for The Washington Post.

"President Biden took urgent action on Wednesday to address the nationwide baby formula shortage, invoking the Defense Production Act to increase production and creating 'Operation Fly Formula' to deploy Defense Department planes and speed formula shipments into the United States from overseas," Annie Karni and Emily Cochrane report for The New York Times. "The White House announced its plan only hours before the House took action of its own, approving an emergency infusion of $28 million for the Food and Drug Administration and a bill to loosen restrictions on what kind of formula can be purchased through the federal food aid program for women and babies."

The $28 million is meant to help the FDA "beef up inspections of formula made at foreign plants and to guard against any future shortages by ensuring the agency is prepared for supply chain disruptions," Nathaniel Weixel and Mychael Schnell report for The Hill. The bill passed on a mainly party-line vote, though 12 Republicans supported the bill in defiance of party leadership.

House Minority Whip Steve Scalise (R-La.) urged House Republicans to oppose the bill, saying it was reckless spending that would provide political cover for the Biden administration while failing to hold the FDA accountable. "House Republicans knocked Democrats for giving money to the FDA without guardrails and without forcing the agency to develop a concrete plan to solve the shortage. At least two House committees are investigating manufacturers and the FDA," Weixel and Schnell report. However, "Democrats argued the FDA does not have enough resources to adequately inspect foreign manufacturers and make sure they meet agency safety standards. The $28 million in emergency funding would make sure the agency can handle those inspections quickly."

A recent Politico investigation found several reasons for the FDA's failure to quickly catch problems at the Abbott plant. The FDA has been underfunded for years, its leaders tend to have far more experience with regulating medications than food, and Trump-era changes in leadership left the agency adrift and—in some cases—caught up in turf wars between feuding officials. All of this happened as the agency was under unprecedented pressure to examine coronavirus vaccines, tests, and treatments.

Meanwhile, some babies and children have already been hurt by the shortage. Doctors in East Texas say they've treated infants who had had seizures after their parents fed them watered-down formula in an effort to stretch their supply. Watered-down formula (or homemade recipes) can endanger babies. And at least two children with intestinal conditions have been treated in a Tennessee hospital because their parents couldn't find the special formula they needed. The formula shortage affects children and even adults with medical conditions that leave them unable to digest regular food. It also disproportionately affects low-wage and other disadvantaged families, Mariel Padilla reports for The 19th. Rutgers University assistant history professor Carla Cevasco spoke with Padilla about the long-standing structural issues that have left low-income families more vulnerable to formula shortages.

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