The Latest Breaking News from FDA

WASHINGTON — David Kessler, a former FDA commissioner who helped steer President Joe Biden’s COVID-19 policy, will leave the administration — as the government’s response continues to gear down amid a waning pandemic and a funding crunch.

Good intentions, bad results

In early January 2023, the U.S. Food and Drug Administration modified its rules for mifepristone, a drug used for medication abortion, allowing it to be offered with a prescription by certified pharmacies. Before this rule change, mifepristone could be dispensed only in person by providers at hospitals, clinics and medical…

It's been six years since a startling story in The New York Times detailed how fatal opioid overdoses were tearing through rural regions of the United States "like a plow through soil." The report came as the nation was beginning to grasp that it faced the deadliest wave of drug…

On Jan. 3, the U.S. Food and Drug Administration took a first step toward making abortion pills available at retail pharmacies. It released new rules outlining how both bricks-and-mortar and mail-order pharmacies can get certified to dispense mifepristone, the first pill in a medication abortion. But the agency also left…

The Food and Drug Administration granted accelerated approval of a disease-modifying treatment that could potentially give some patients with Alzheimer's disease something they haven't had before: a medication that may slow the decline of memory and thinking.

Canada’s drug prices are the fourth highest in the developed world. Despite this, Innovative Medicines Canada (IMC), the lobby group for Big Pharma, put out a call in November 2022 for the Canadian government to suspend consultations on guidelines aimed at lowering prescription drug prices.

Leqembi can slow early progression by months but has safety concerns. Most patients will likely have to wait months to get the IV drug, which will cost about $26,500 a year. Insurers need to decide whether and how much to cover it. Medicare isn’t expected to pay for it until…

Precisely when human life begins is above our pay grade, but at a time when states are radically restricting women’s right to seek reproductive health care — and forcing rape and incest victims, among others, to give birth — policymakers in Washington ought to be wisely using the levers of…