Wednesday, September 15, 2021
I'm finding myself spending a lot of time reading and thinking about the Food and Drug Administration (FDA) and Federal Trade Commission (FTC). Of course, public concerns about the efficacy of Covid-10 vaccines dominate the attention of many of us working on health-related legal concerns that affect older adults. For example, I've been researching questions about the potential for FDA approved antibody tests for Covid-19 vaccines.
But also intriguing is a report that a slow-moving FTC suit against developers and marketers of the dietary supplement known as Prevagen may be getting closer to a possible trial date in the Southern District of New York. A dismissal of the 2017 law suit filed jointly by the FTC and the New York Attorney General was overturned in 2019 by the Second Circuit in a summary order, concluding that the "FTC and New York have made plausible allegations that Defendants] marketing campaign for Prevagen contained deceptive representations." For more on this and other Prevagen-related suits, see the Washington Post's recent article Does the Supplement Prevagen Improve Memory? A Court Case is Asking that Question.
Plus, there are significant questions arising in the wake of the FDA's June 7, 2021 announcement of its "accelerated" approval of aducanumab for treatment of Alzheimer's Disease. See e.g., Recently Approved Alzheimer Drug Raises Questions that May Never Be Answered (JAMA Network, July 21, 2021).
As noted in Dr. Jason Karlawish's important new book, The Problem of Alzheimer's: How Science, Culture, and Politics Turned a Rare Disease into a Crisis and What We Can Do About It, the number of Alzheimer's patients in the U.S. will rise to an estimated 13.8 million by 2025. The caregiver market alone is searching desperately for answers, and it can be very hard to make individual decisions about risks and benefits without trustworthy information. This is a tough time for what we might call a pandemic crisis about "trust."