The first shipment of naloxone in a new national effort to reverse overdoses arrived somewhat unceremoniously.

When FDA announced last month it had commissioned an outside evaluation of its foods program (as well as tobacco), it was seen by many as a formal, if somewhat tepid, admission that something had gone very wrong at the agency.

While most regular folks wouldn’t give a hill of beans about the organization of bureaucracies in Washington, D.C., frustrated taxpayers should be taking note of seismic rumblings about restructurings that are shaking some of the biggest, most powerful, and influential federal health agencies. Biden Administration officials, in one of their notable moves, have announced that responses to pandemics and other public health crises will be led now by a separate, independent division within the sprawling Health and Human Services agency.

On July 20, Robert Califf, the head of the Food and Drug Administration (FDA), announced that he would commission external experts to conduct “a comprehensive evaluation” of the agency’s food and nicotine divisions. Read more

Facing sharp criticism in the media that FDA’s approach to food safety is “broken,” “Byzantine” and a “ridiculous joke,” the agency is undertaking a “top to bottom” review of the “structure, function, funding and leadership” of its food program, agency representatives told Congress yesterday. Read more

The head of the Food and Drug Administration said Tuesday he is asking outside experts to conduct a comprehensive evaluation of the agency’s food and tobacco programs, which in recent months have endured sharp criticism involving two high-profile issues: the infant-formula shortage and e-cigarettes, particularly the vaping company Juul.

In February 2022, I rejoined the U.S. Food and Drug Administration as Commissioner of Food and Drugs, having served in the role five years earlier. Since my return, the agency has taken many significant actions that benefit the public health. 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.