FDA actions increase homelessness by restricting antipsychotic access

In the United States, homelessness remains a significant issue, with a notable link to mental health disorders such as schizophrenia. Experts like Singer and Bloom have pointed out that the FDA's Risk Evaluation and Mitigation Strategies (REMS) have led to the underprescription of clozapine, a crucial medication for treatment-resistant schizophrenia. The FDA categorized clozapine under REMS in 2015 due to a rare side effect called agranulocytosis, which results in a dangerous drop in white blood cell count. However, this requirement mandates that patients undergo weekly blood tests for the first six months, then bi-weekly for an additional six months, and finally monthly for life if the tests remain normal. This cumbersome process has discouraged healthcare providers from prescribing clozapine, resulting in only 4% of schizophrenia patients in the U.S. receiving it, despite 30% of those affected not responding to standard treatments. The experts argue that the REMS is not proportionate to the actual risks associated with clozapine, given that the likelihood of agranulocytosis decreases significantly after a few months of treatment and that the risks of blood abnormalities are comparable to those of other antipsychotic medications that do not have such stringent monitoring. The current monitoring requirements prevent access to effective medication for those most in need, potentially worsening homelessness and other related mental health issues. Advocates of mental health treatment are calling for a change in FDA policies to alleviate the burdens imposed by REMS, suggesting a system more akin to practices in other countries, which could save lives by increasing access to medications that are essential for individuals who struggle with severe mental illness.