By B.N. Frank
The Food and Drug Administration (FDA) has a long history of failing to protect Americans from unsafe products in a timely manner (see 1, 2, 3, 4, 5, 6, 7, 8). Some blame more than obliviousness for this. The agency has been accused of making many decisions that deliberately and catastrophically hurt the public – like “igniting” the Opioid Crisis.
More recently the agency’s approval of a new Alzheimer’s drug has health advocates, industry experts, and researchers completely up in arms.
From Ars Technica:
FDA officials asked to step down after contentious Alzheimer’s drug approval
Three experts resigned in protest. Watchdog says it’s FDA brass that should leave.
A leading advocacy and watchdog group is calling for the ouster of three top officials at the Food and Drug Administration—including its acting commissioner—after the regulator issued a highly contentious approval last week of the unproven and now highly priced Alzheimer’s drug Aduhelm (generic name: aducanumab).
The call for fresh FDA leadership comes atop a chorus of harsh criticism over the decision, which outside researchers and industry experts have called “disgraceful” and “dangerous,” among other things.
Since Aduhelm’s approval was announced June 7, three expert advisers to the FDA have resigned in protest, with one calling the decision “probably the worst drug-approval decision in recent US history.” The three experts were part of an 11-member advisory committee that reviewed the clinical data for the Alzheimer’s drug last November and voted nearly unanimously against approval (10 voted against, 1 voted “uncertain”).
On Wednesday, advocacy group Public Citizen only increased the din of criticism, calling the FDA’s approval “reckless.” The FDA’s decision “showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency,” Michael Carome, director of Public Citizen’s Health Research Group, said in a statement. “The sheer recklessness of the FDA’s approval of aducanumab cannot be overstated. This decision is a disastrous blow to the agency’s credibility, public health and the financial sustainability of the Medicare program.” The latter point refers to the fact that Aduhelm’s developer, Biogen, set the drug’s list price at $56,000 for a year’s supply.
In a letter addressed to Xavier Becerra, secretary of the Department of Health and Human Services, Dr. Carome and Public Citizen called for the immediate resignation or removal of three top FDA officials, whom they described as “most responsible” for the approval. They are: acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, and CDER Office of Neuroscience (ON) Director Billy Dunn.
“New leadership of the FDA and CDER is a prerequisite for restoring the agency’s credibility and reversing the slide in the agency’s standards for ensuring the safety and effectiveness of new drugs,” Carome said in the letter. “You should direct the next Acting FDA Commissioner to consider whether the agency’s approval of Biogen’s BLA for aducanumab should be withdrawn.”
Flaws and mistakes…
On a positive note, the FDA did issue a warning last month about the potential for cell phones and smart watches to cause serious and potentially deadly interference issues with medical implants, pacemakers and cardio defibrillators. Considering the popularity of these devices among people of all ages and the increasing number of Americans with medical implants, this is definitely need-to-know information. Better late than never, right?
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