Aducanumab has just been approved by the Food and Drug Administration to slow the progress of Alzheimer’s disease. It is likely that many people who are candidates for the drug will no longer be competent to make their own health care decisions, and will be relying heavily on others to make the decision with them or for them. As a layperson, how would I evaluate the risks and benefits of this drug, were I acting as a health care proxy for someone with Alzheimer’s disease?

June 7, 2021, was a bad day for science. That was the day Food and Drug Administration approved aducanumab for the treatment of Alzheimer’s disease, even though a committee of its own selected experts recommended strongly against approval.

In January, right before President Biden took office, the Food and Drug Administration proposed permanently exempting “software as a medical device” from regulatory review. The agency waived the approval process last year to streamline regulatory oversight during the Covid emergency. But the growing use of artificial intelligence programs and digital devices in health care raises safety and ethical concerns that require more attention. The Biden administration put the proposal on hold for now. Meanwhile, bioethicists should weigh in as the FDA reviews its action plan.

The Food and Drug Administration's rigorous guidance for an emergency use authorization of a Covid vaccine was met by resistance from the White House, since some of the terms would make it virtually impossible to issue a vaccine-related emergency authorization before Election Day. Understanding the ethical dimensions of issuing it for a vaccine can provide clarity on the necessity of the FDA’s stringent guidelines.