Members of the House of Representatives took turns lashing out at Food and Drug Administration Commissioner Robert Califf on Wednesday over the baby formula shortage. Congress always needs a punching bag, but the main culprit is the FDA giant.
dr Califf was confirmed in his post on Feb. 15, two days before Abbott’s formula recall. He cannot be held responsible for the agency’s reluctance to respond to problems at the plant. But he and other agency heads could have acted more quickly to address the formula shortage, which is due in large part to FDA regulation.
A whistleblower report last October claimed unsanitary conditions at the facility. Between September and February, four infants became seriously ill with a dangerous bacterium after consuming factory-made infant formula. The agency’s follow-up inspection, which began in late January, found “extremely unsanitary” conditions, including cracked equipment, standing water and leaking roofs.
dr Califf said senior officials were unaware of the whistleblower complaint until about February 9, which isn’t surprising given the FDA’s extensive regulatory portfolio. Its 18,000 employees oversee pharmaceuticals, medical devices, food safety, tobacco products, veterinary medicine, baby food and even sunscreen. Executives cannot be expected to know every regulatory issue in every department.
But after the recall and plant closure, they could have ensured the US had enough formula by waiving FDA labeling and ingredient regulations that restrict imports from trusted sources like Europe. The agency’s failure to relax import regulations by last week stems from its longstanding culture of bureaucratic scrutiny. Remember how slow it was at the beginning of the pandemic to allow alternative Covid tests performed by private laboratories and hospitals.
A broader lesson for Congress is that regulators with too much authority will do too little with authority.
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https://www.wsj.com/articles/the-baby-formula-fall-guy-fda-commissioner-robert-califf-congress-hearing-11653515261 The Baby Formula Shortage Fall Guy