Coverage

In 2021, a record number of Americans – more than 107,000 – died from drug overdoses. While the loss of human life alone is staggering, we know that the effects of the drug overdose crisis are even broader, including enormous individual and societal…
In June, long-simmering criticism of the way the U.S. Food and Drug Administration is handling premarket tobacco product applications (PMTAs) culminated in a public uproar. “The whole regulatory process is becoming surreal now,” wrote Clive Bates, an…
Work is poised to get underway on a somewhat rare internal review by the U.S. Food and Drug Administration (FDA) that could impact how the agency processes new tobacco products and enforces the sale of them by retailers. Read more.
The Reagan-Udall Foundation this week announced that Jane Henney, who served as FDA commissioner during the final years of the Clinton administration, will lead the external review of FDA’s foods program. Read more
The CDC isn’t the only federal regulator taking a cold, hard look in the mirror: Food and Drug Administration Commissioner Robert Califf called on the Reagan-Udall Foundation to review two offices within the agency. Read more
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. “Fundamental questions…
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…
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…