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 independent public health and sustainability advocate, on his blog The Counterfactual.
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.
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.
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.
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.
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.
