Opinion Article in BMJ Evidence-Based Medicine: FDA Pathway for Drug Innovations Allows Approval of High-Priced, Minimally Modified Drugs Based on Limited Data
In an opinion article published in BMJ Evidence-Based Medicine on March 2, 2026, researchers from the University of California San Francisco, Yale School of Medicine, and Public Citizen’s Health Research Group explained how a little-known Food and Drug Administration (FDA) pathway for drug innovations, known as 505(b)(2), allows for the approval of high-priced, minimally modified drugs based on limited data. The researchers recommended targeted reforms to the FDA and the Centers for Medicare and Medicaid Services on how to close this regulatory loophole with targeted reforms.
The example discussed is benzgalantamine (ZUNVEYL), an oral drug approved by the FDA in 2024 for the treatment of mild or moderate dementia in adults with Alzheimer’s disease. The approval of benzgalantamine relied on the efficacy and safety data for galantamine (generic only), another drug for Alzheimer’s disease that the FDA approved in 2001. Benzgalantamine is a prodrug, a pharmacologically inactive compound, that is converted into galantamine when it is metabolized in the body. Public Citizen’s Health Research Group has classified both benzgalantamine and galanatamine as Do Not Use drugs.