Perspectives: FDA Officials Explain Why They Approved Alzheimer’s Drug
Read recent commentaries about drug-cost issues.
The Washington Post:
Here’s Why We Approved The First New Alzheimer’s Drug In Two Decades
Earlier this month, the Food and Drug Administration approved aducanumab (under the brand name Aduhelm), the first new drug for the treatment of Alzheimer’s disease in nearly 20 years. Patients with Alzheimer’s have shared stories of the disease’s devastating effects, including knowing that it will alter their sense of who they are and rob them of the ability to care for themselves. We understand that an approval of this magnitude is of intense interest, so we want to explain what we have done and why we have done it. The decision to approve this drug was based on rigorous science, with thorough evaluation of data from clinical studies. The FDA conducted an extensive review of current and relevant scientific literature and carefully considered feedback from the advisory committee. The evidence was complicated and, in some instances, contradictory. After reviewing the data, we concluded evidence from the trials did not, on its own, convincingly demonstrate a clinical benefit and did not meet the standard for “regular” approval. That’s what we heard from the advisory committee, and we agreed. (Patrizia Cavazzoni, Billy Dunn and Peter Stein, 6/23)
Also —
Stat:
Biden Won't End Cancer By Importing European Drug Price Controls
In his first budget, President Biden set aggressive health goals. “Let’s end cancer as we know it,” he said to rousing applause in a speech to Congress. “It’s within our power. It’s within our power to do it.” Cancer is not all Biden wants to end. His budget also increases funding by two-thirds to meet the goal of “ending the HIV epidemic” in the U.S. by 2030. Then there’s Alzheimer’s, which the budget listed, along with cancer and diabetes, as targets of a large new research and development unit within the National Institutes of Health. Alzheimer’s costs the U.S. $277 billion a year. And, of course, the president wants to end the Covid-19 pandemic, which is still killing hundreds of Americans every day. (James K. Glassman, 6/28)
The Maine Wire:
Should California Be Able To Set Drug Prices In Maine?
Imagine if California passed a law telling Maine lobstermen how much to charge for their lobsters – in Maine. The idea isn’t just ridiculous, it would be unconstitutional. That’s why it’s so disappointing that the Maine Legislature passed a bill, LD 1117, that proposes to regulate prices outside the state. Governor Mills must veto it. (Jeffrey Francer, 6/29)
NJ.com:
My Son Nearly Died Because Of ‘Step Therapy’
As the mother of a 13-year-old son with type 1 diabetes, and the wife of a husband with a disability, I truly believe there is the right medicine for the right patient at the right time. Unfortunately, my belief is this strong because I’ve seen what can occur when the right therapy for a patient is disrupted. My son has endured multiple negative health events because of the dangerous practice of step therapy, also known as “fail first,” which is sorely in need of reform in New Jersey. (Lis Parlett Butcher, 6/20)
