U.S. Food and Drug Administration (FDA) Commissioner Robert Califf announced that the agency would be commissioning an external review of its activities.
"Since my return, the agency has taken many significant actions that benefit the public health," Califf said in a statement. "Yet at the same time, the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency's operations, prompting me to take a closer look at how we do business. As a result, for two of the agency's key programs, I have commissioned external agency experts to conduct a comprehensive evaluation."
The Reagan-Udall Foundation, a non-profit supporting the FDA in furthering food safety in the US, has been tapped to conduct the review. In his statement, Califf noted that the foundation would be working with an "external group of experts" to conduct the evaluation.
The move seemingly comes in response to the controversies that have dominated Califf's return to the FDA.
The agency's delayed response to contamination at a major baby formula facility contributed heavily to the plant's extended shut down, and the steep impact on many low-income parents. According to an agency whistleblower, the FDA received a complaint of contamination in October, but it did not reach the proper officials until February. The resulting criticism from members of Congress and the media severely degraded the agency's reputation.
The agency also mishandled the processing of Juul Labs' application to sell in the U.S., banning its products from sale on June 23 citing a lack of toxicology data. The order was blocked by an appeals court the following day, with the FDA rescinding its ban on July 5.
The FDA's reversal on its Juul ban outraged anti-vaping advocates, with Democratic Senator Richard Durbin of Illinois calling the agency out for its rapid turnaround. Durbin has since called on the agency to re-affirm a strong stance against teen vaping, particularly against disposable products such as Puff Bar that are popular among younger consumers.
To its credit, however, the FDA's evaluation appears to be rather far-reaching and could prompt the agency to make substantial changes to avoid further regulatory fiascos. Regarding its evaluation of food safety review programs, the agency noted that "fundamental questions about the structure, function, funding and leadership need to be addressed." Regarding tobacco products, the agency noted that it had to deeply reconsider how it approached the growing array of novel vaping/smoking devices on the domestic market.