FDA: Infant formula supply will increase quickly

Food and Drug Administration Commissioner Robert Califf on Thursday promised a swift end to the infant formula shortage, telling a House appropriations panel that his agency is committed to preventing future shortfalls and promising that the Biden administration’s recent actions will begin to stem the crisis within a few days.

Califf said that while the White House’s invocation of the 1950 Defense Production Act, the Defense Department’s use of military commercial planes to transport formula supplies and the FDA’s new importation guidelines will begin to have an impact “within days,” “it will be a few weeks before we’re back to normal.”

He appeared before the House Agriculture Appropriations Subcommittee to discuss the agency’s budget request for fiscal 2023, though lawmakers spent little time discussing policy beyond the formula shortage.

House Appropriations Chair Rosa DeLauro, D-Conn., focused on the cause of the problem, accusing the FDA of lacking oversight of Abbott Nutrition.

The Abbott Nutrition plant was shut down earlier this year after contamination issues that were believed to have caused the death of two infants. A whistleblower sent the FDA a 34-page report in October 2021 outlining issues at the Abbott plant, but the agency did not take action for several months.

“It all begs the question, why did the FDA not spring into action?” DeLauro said. “It makes me question which side the FDA is on.”

Califf told her that he anticipates the Michigan production plant will reopen in the next week or two — two weeks being the absolute longest.

His testimony comes one day after the House passed a bill  to provide $28 million in emergency funding for the FDA for formula inspections and monitoring. The House on Wednesday also passed a bill to extend Special Supplemental Nutrition Program for Women, Infants and Children (WIC) infant formula flexibilities that the Biden administration was able to recently trigger only because of the ongoing COVID-19 public health emergency.

On Thursday, the Senate cleared by unanimous consent the latter WIC bill. It would give states flexibility in administering the nutrition program during extenuating circumstances such as supply chain disruptions. That measure now heads to President Joe Biden.

Califf told Rep. Dan Newhouse, R-Wash., that the $28 million supplemental would go largely toward safety inspections, both at infant formula plants domestically and abroad. Right now, the infant formula inspection office has only nine staff members. When lawmakers expressed concern about this, Califf replied that the entire food side of the FDA is understaffed.

The supplemental still has to move through the Senate, where its future remains uncertain. Senate Appropriations ranking member Richard C. Shelby, R-Ala., cast doubt Thursday on whether the Senate should give the FDA more money.

“The real question there is, do they need it. … Can the FDA handle it?” Shelby said of the supplemental’s future in the Senate.

Administrative action

Also Wednesday, Biden invoked the 1950 Defense Production Act to increase formula supplies. He also directed agencies to use military commercial aircraft to pick up overseas infant formula to get it to store shelves faster.

A senior White House official told reporters Thursday that supply challenges vary state to state and it’s difficult to get data on which parts of the country are missing which formula.

“It has been interesting to hear the number of states who say that they’re not actually seeing a problem,” the senior administration official said.

The Agriculture and Health and Human Services departments’ partnership with the Department of Defense will help aircraft carrying baby formula bypass traditional routes and get to areas that need supply quicker. The planes will land in an airfield close to the factory or manufacturing facility that needs the supply, and the product will be subject to FDA inspection after being unloaded.

Sandhya Raman contributed to this report.