Politico: FDA timeline shows bungling on formula shortage -- but also months of inaction by Biden

AP Photo/Patrick Semansky

When Robert Califf testifies today in a House committee hearing, the FDA commissioner will blame “mailroom issues” for a lack of response to the origins of the infant-formula shortage. However, Politico’s report on Cardiff’s prepared testimony raises a few other questions that neither Cardiff nor Politico address. If the FDA finally figured out what was going on in early February, why did it take the White House an additional three months to react to it?


Does Joe Biden also have “mailroom issues”?

In their prepared testimony released Tuesday evening, FDA Commissioner Robert Califf and several senior officials for the first time lay out a timeline of the agency’s response to reports last fall that infants had been hospitalized after consuming formula made at an Abbott Nutrition plant in Sturgis, Mich. And they say a whistleblower report alleging food safety problems at the plant, which was mailed in October, did not reach the FDA’s highest rungs until mid-February, despite being sent directly to then-acting Commissioner Janet Woodcock and others. …

The FDA timeline laid out in the prepared testimony acknowledges the FDA didn’t hold interagency discussions about potential supply chain disruptions until Feb. 14, three days before the Abbott Nutrition plant at the center of the current shortages shut down and issued a formula recall. And the agency didn’t notify the Agriculture Department, which oversees a critical federal nutrition program that purchases about half of the nation’s infant formula, about potential disruptions until a week before the Abbott plant shut down. The program, known as WIC, serves 1.2 million infants from low-income families. Abbott supplies nearly half of all infant formula provided through WIC state contracts.

The testimony also blames “mailroom issues” for the fact that senior FDA officials, including Woodcock and FDA’s top food safety official, Susan Mayne, did not receive hard copies of the whistleblower report from last October detailing alarming concerns about the Abbott plant, including poor food safety practices and that officials there had falsified documents and intentionally information from FDA inspectors. The FDA did not interview the whistleblower until December.

According to Califf’s testimony, Woodcock and Mayne eventually received the whistleblower report via email from another FDA staffer on Feb. 14, three days before the recall. The agency says copies of the whistleblower report sent to Mayne and another FDA official were found in the FDA’s mailroom in May, but officials have yet to locate the copy sent to Woodcock. It was “likely due to COVID-19 staffing issues” and “a mailroom analysis is underway,” the prepared remarks state.


All right, that brings us up to about mid-February. Even though the FDA knew enough by mid-January to recommend that Abbott issue a recall, that didn’t get made public until February 17. That’s also when the FDA began coordinating with the USDA on the potential devastating effects the recall and potential inventory shortages would have on the WIC program.

So let’s use February 17. Why did it take three months for the White House to react? Let’s not forget that the New York Times raised the issue of formula shortages in early October 2021, not on the basis of an FDA recall and shutdown but because the supply-chain crisis had restricted access to precursor ingredients. Similarly, the Wall Street Journal reported on the shortage in January, again before the recall and shutdown of the Abbott facility. The Washington Post picked it up in April, apparently having more insight than the White House about what the FDA was doing.

Maybe their mailroom is more efficient.

From the Politico report, it sounds as though Cardiff plans to fall on the FDA’s sword today to take some heat off the White House, but this timeline shows how absurd that is. The Abbott recall and FDA shutdown made the shortage worse, but it didn’t create it, and furthermore that took place a full three months before the White House finally reacted by putting up a lame website. At the very end, Politico quotes an anonymous Biden administration official who claimed that they had been “very public about our activity” since February 17, but that’s nonsense. They didn’t take any action until media outrage over empty shelves and starving infants finally became a national media focus early this month, and the only reaction they could muster at first was to post the customer-service numbers of manufacturers. A week later, they finally began to address the situation by overriding the FDA’s labeling regulations and the FTC’s trade barriers to fly pallets of formula in from Europe, but it will take months at that scale to address the shortage in all markets.


Politico buried its lede here. Yes, the FDA may have had “mailroom issues” that delayed the crisis from getting attention at first, but the White House has a leadership issue that prevents it from proactively responding before issues turn into crises. And that leadership issue is Joe Biden’s utter incompetence.

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