Alzheimer’s Association Urges Biogen To Lower Price Of Aduhelm

Stat: Alzheimer's Association Blasts Biogen Over Price Of New Drug Aduhelm
In harsh tones, the Alzheimer’s Association sharply criticized Biogen for the $56,000 price tag placed on its newly approved Alzheimer’s treatment, a move that threatens to embroil the biotech company and its medication in yet another national controversy. The patient advocacy group released a brief statement on Saturday calling the wholesale price “simply unacceptable” and that, for many people, it “will pose an insurmountable barrier to access … and may further deepen issues of health equity.” The organization expressed gratitude that the drug was approved in response to a “vast unmet need,” but called on Biogen to change the price. (Silverman, 6/12)

CNBC: Biogen Alzheimer’s Drug And The New Battle Over Dementia Treatment
The FDA’s approval of Biogen’s Alzheimer’s drug Aduhelm was a landmark moment in the life of Dr. Paul Aisen. The director of the Alzheimer’s Therapeutic Research Institute at USC has spent the past three decades focused on treating the neurodegenerative disease, and in recent years helped shepherd this particular drug through the various phases of clinical trials. But sitting in his sun-drenched office in San Diego in early June, he felt slightly confounded by the manner in which the Food and Drug Administration approved its use on an “accelerated” basis, which is usually reserved for cancer medications. This meant its clinical benefits were considered likely, but approval for long-term use would be subject to more extensive study in a fourth phase of trials. (Marx, 6/12)

Stat: ‘I'm Just Winging It’: Confusing Alzheimer's Drug Data Cloud Doctors' Advice
Their phones are ringing off the hook and their email inboxes are filling up with questions without answers. Doctors who care for patients diagnosed with Alzheimer’s disease — or people worried that they might be — are feeling the brunt of last week’s decision by the Food and Drug Administration to grant conditional approval to the first new Alzheimer’s drug in 18 years. That approval is broad, making no distinction between the mild, moderate, and advanced stages of the memory-robbing disease and setting no requirements for its diagnosis. (Cooney, 6/14)

KHN: Journalists Discuss New Alzheimer’s Drug, Women’s Alcohol Use, The Hip-Hop And Opioids Link
KHN chief Washington correspondent Julie Rovner discussed the FDA’s approval of a new drug for Alzheimer’s disease on WAMU’s “1A” on Wednesday. ... KHN correspondent Aneri Pattani discussed the increase in alcohol use and misuse by young women on NPR’s “All Things Considered” on Wednesday. (6/12)

In related news —

Politico: Controversial Drug Approval Stokes Concern About Lack Of A Permanent FDA Chief 
The Food and Drug Administration’s approval of a controversial new Alzheimer’s drug this week has hardened opposition to acting commissioner Janet Woodcock, who remains President Joe Biden’s apparent favorite to be the agency’s permanent leader. The administration's search for a permanent FDA head has dragged on for months during an unprecedented public health crisis. Woodcock, a veteran regulator, has presided over major decisions on the pandemic response, tobacco and new medicines — including the $56,000-a-year Biogen Alzheimer's drug approved Monday despite thin evidence that it works. (Owermohle, Cancryn and Gardner, 6/11)

The New York Times: F.D.A. Still Lacks A Permanent Commissioner 
The contested decision by the Food and Drug Administration earlier this week to approve a drug to treat Alzheimer’s has renewed concerns about the Biden administration’s prolonged delay in choosing a permanent commissioner to lead the agency. It has also once again exposed the sharp divide between supporters and detractors of the F.D.A.’s interim commissioner, Dr. Janet Woodcock, the longtime chief of the agency’s drug division who has seemed to be on an extended tryout for the top post. (Kaplan, 6/12)