On 5/26/2022, Senator Richard Burr, Ranking Member of the Senate HELP Committee, criticized the FDA for its failure and unwillingness to address potential shortage concerns last fall, which has left families struggling to find formula on store shelves. He said, “The question I could not answer for my constituent was, ‘what took the FDA so long?’ “Why wasn’t action taken when the warning signs of this crisis started last fall? She asked if we knew what the FDA stands for. Before we could reply, she said it stood for ‘Formula Doesn’t Arrive.’ “Formula Doesn’t Arrive.

“Yesterday in testimony to the House you tried to shift the blame. The mail room didn’t deliver whistle blower complain, it’s your mail room and the FDA knew there was a problem even before the whistle blower sent the letter. “Yesterday you said you were new, but the President hired you and the Senate confirmed you because you had been there before. And your center director has been there almost a decade. Strike two. Yesterday you said the FDA could have done better. That’s painfully obvious, but where is the accountability?”

“Babies with special needs, dietary restrictions, adopted families and foster families. Orphaned children. Children with mothers who are immune compromised or on lifesaving treatments. Women who can’t breastfeed, and some cancer survivors. I want to share a story with my colleagues about one of these millions of Americans. When she called my office to demand accountability from her government, she was confused that the White House seemed to be blaming the formula manufacturer.

“Abbott began flying formula to the U.S. from overseas in February, 11 million pounds since February, 50 flights a week, six to eight flights a day of 132,000 cans to 12 different airports around the country. Abbott has been very transparent about what problems they’ve faced and what they were doing to fix the problem. Their CEO even published an editorial apologizing for their part in this crisis.

“This month, CDC closed its investigation into the infection of four children, finding no direct link to the manufacturer’s facility, but the FDA only just now has begun to use tools to increase the supply of formula. And FDA still hasn’t authorized the Abbott plant to resume manufacturing even though CDC determined the original contamination didn’t come from Abbott’s plant.

“My friends, the FDA failed to do its job. Plain and simple. This isn’t a story about funding. Congress provides over $1 billion for the food center alone every year … The House passed a bill to give an additional $28 million to the FDA. Ladies and gentlemen, that’s called political cover. This money is a stunt, so people could go home and say they did something.

“That’s dishonest at best. And blatantly irresponsible at worst. The American people know better who’s at fault here. This also isn’t a story about authority. The Food Drug and Cosmetic Act authorities are clear. The flexibility you have is real. No, this is a story, a sad story, about the FDA’s unwillingness or inability to do its job.

“Dr. Califf, you were confirmed in February when the nationwide formula shortage was at 26 percent. There was a problem, and you and your agency failed to solve it … But what I cautioned against is already happening – FDA is slipping back in to its bureaucratic, bad old ways. The FDA gets $6 billion from Congress each year. Over 18,000 staff. Yet, you fail to prioritize the things that matter. For the past two years, the food center ignored the formula crisis until it became a political liability for this Administration.

“Instead, the center focused on reducing salt in foods, what kinds of salad dressing we can call ‘French dressing,’ and the ingredients that can be in yogurt. You had time to decide what color additives can be added to make farmed salmon look more pink and work on consumer acceptance of grated parmesan cheese.

“Infants, babies and toddlers are starving and parents are facing the reality that they can’t feed their child in the United States of America and your food center is more interested in policing marketing claims about cheese than ensuring that American families have the formula to feed their babies.

“That you are acting only now, under pressure from outraged parents around the country and from Congress, deserves some serious soul searching … The Abbott CEO apologized for their mistakes, when will the FDA apologize?

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FDA stood for ‘Formula Doesn’t Arrive.’ Blame mail room, blame manufacturer, blame funding.