As the Food and Drug Administration moves closer to a decision about whether to approve a promising new Alzheimer’s treatment, the collaboration between scientists, regulators, and business leaders that produced this encouraging drug has come under fire as a “black eye” for the FDA that “dangerously compromised” its objectivity. This unfortunate charge misconstrues the drug development process and the indispensable partnerships that are needed to deliver new treatments.
The drug in question, aducanumab, takes aim at Alzheimer’s disease, the sixth leading cause of death in the U.S. and the only disease in the top 10 that has no cure and no treatment to slow its devastating impact. About 5.7 million Americans already live with Alzheimer’s, a figure projected to triple by 2050. Managing the disease cost the U.S. $305 billion in 2020, and is estimated to rise to $1.1 trillion per year by 2050.