NCHR Testimony on Descovy for PrEP

August 7, 2019. We understand the desire to provide a new PrEP treatment indicated for a broad population, especially when that new treatment is expected to potentially have fewer risks for kidneys and bone density. However, it is inappropriate and potentially dangerous to approve this drug for subgroups of patients that haven’t been adequately studied.  The FDA law requires substantial evidence that the benefits outweigh the risks for each subpopulation that the new indication would include.

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