A look at FDA’s Newly Issued Internal Report

On Tuesday, September 20, 2022, FDA issued a report following an internal agency review, ordered by FDA Commissioner Dr. Robert Califf, of the agency’s actions related to multiple reports of Cronobacter illness in infants, Abbott’s infant formula manufacturing plant in Sturgis, Michigan, and a confluence of “systemic vulnerabilities” that ultimately led to the unexpected infant formula shake-up and shortages this year.

Based on more than 40+ interviews with 60+ FDA staff and leadership directly involved in the events, FDA highlights major areas needing improvement:

• Modern information technology

• More staff, training, equipment and regulatory authorities

• Updated emergency response systems that can handle multiple and simultaneously occurring public health emergencies

• Increased scientific understanding about Cronobacter, which is found in infant formula

• Better understanding of the formula industry, including its preventive controls, food safety culture and preparedness to respond to events

Following the recall of major infant formula brands and a shutdown of a key manufacturing plant earlier this year, FDA found that delays, lack of procedures and resources, and limits on FDA’s authority ultimately shaped FDA’s response and exacerbated shortages caused by significant supply chain disruptions. Specifically, the report highlights FDA’s missteps and delays in handling a whistleblower complaint related to the contamination at the Abbott Nutrition’s manufacturing facility in Sturgis, Michigan. The report also states that FDA did not have staff training to quickly escalate complaints for senior review, lacked clear internal processes to coordinate effective response, and lacked processes to require companies share information remotely, while the pandemic delayed FDA’s in-person response at the manufacturing facility.

FDA stated that while the issues were magnified due to the nature of infant formula as the sole source of nutrition for vulnerable populations, the lessons learned can be applied across the repertoire of FDA products.

Significantly, FDA Commissioner Califf provides interesting promise and possibly an open door for change in the regulatory landscape: Califf stated that while domestic formula manufacturers heeded their call to duty and helped increase formula supply, “the long-term resiliency of the infant formula supply chain will rely on greater diversification of manufacturers, including new entrants to the U.S. marketplace, investment in new manufacturing facilities by infant formula producers and a commitment by these companies to consistently and continuously adhere to the FDA’s quality and safety standards. Ultimately, these combined approaches will protect the most vulnerable individuals.” The Commissioner re-affirmed FDA’s commitment to implementing the necessary changes to avoid future supply shortages.

While it is too early to tell the measures FDA may take to create such flexibility, the fact that there is a commitment in making this happen speaks volumes (of hopefully reliable and safe infant formula for years to come!).