The First of its Kind: An FDA-Approved Drug Label that Promises Delayed Incarceration
Updated: Dec 29, 2019
It seems many were flummoxed by the recent FDA approval of a label amendment for the established schizophrenia drug Invega Sustenna®. The amendment will stipulate that the drug can delay the arrest or incarceration of patients with schizophrenia who take it  (the revised label is not yet available at the online FDA drug database). Does that sound ludicrous to you? Wait until you hear the facts.
According to Mental Health America (MHA), a nonprofit founded in 1909 that addresses the needs of those living with mental illness and promotes the overall mental health of all Americans, 1.2 million individuals living with mental illness sit in jail and prison each year. MHA states:
People with mental-health problems come into contact with police for factors related to their mental-health problems. These factors should not be a reason for incarceration. When possible, these individuals . . . should be diverted to treatment or peer-run crisis-respite models—not sent to the police station for booking.
Of interest, according to US Bureau of Justice data, states with less access to mental-health care have more adults in the criminal justice system.
For a different portrayal of the numbers, consider that the National Research Council (NRC) reports 64% of jail inmates, 54% of state prisoners, and 45% of federal prisoners claim mental-health concerns. The NRC also estimates that 1 of every 100 Americans is incarcerated. The US is the world leader in incarceration.
Outside of the jail and prison systems, 43 million Americans have a mental-health condition, yet 57% have not received treatment.
Many experts believe that the reason the jail and prison population has swelled is our inability to manage the mental-health crisis in this country. The “deinstitutionalization” movement of the 1960s shut down large treatment facilities and released mentally ill people to live in the general population. Poor healthcare coverage has forced many to go without. This is, of course, a cursory description of a complex situation. But the fact is, many of these folks end up jail. The authors of a 2017 study in BMC Public Health assert that correctional facilities have become a front line for mental-health care.
The executive director of the Treatment Advocacy Center, a national non-profit organization dedicated to eliminating barriers to the timely and effective treatment of severe mental illness, has stated that schizophrenia is really the only illness for which one of the major side effects is jail time. Certainly, Janssen Pharmaceuticals knows this to be true.
The FDA approval of Janssen’s label alteration was based on the results of a study in 444 patients randomly assigned to either Invega Sustenna (n=226) or a commonly prescribed antipsychotic medication (n=218). Patients had schizophrenia and a history of incarceration (all had been arrested at least twice in the 2 years leading up to the trial). The primary endpoint was time to first treatment failure, and one of the definitions of treatment failure was arrest and/or incarceration. During the 15-month treatment phase, the median time to treatment failure was 416 days for Invega Sustenna and 226 days for other antipsychotic medications—a statistically significant difference (P=0.011).
So you see, while the label amendment highlights the wretched condition of mental healthcare and justice in the US, it did arise from a real patient need. Meanwhile, perhaps we can work on root causes.
1. Janssen Pharmaceuticals, Inc. Press release. January 3, 2018. Accessed March 2, 2018 at http://www.janssen.com/landmark-schizophrenia-data-bring-hope-breaking-cycle-hospitalization-and-incarceration-receive-fda. 2. Mental Health America. Access to mental health care and incarceration. Accessed March 2, 2018 at www.mentalhealthamerica.net/issues/access-mental-health-care-and-incarceration. 3. American Psychological Association. Incarceration nation. Monitor on Psychology. 2014; 45(9). Available at www.apa.org/monitor/2014/10/incarceration.aspx. 4. Mental Health America. State of Mental Health Report, 2018. Accessed March 2, 2018 at www.mentalhealthamerica.net/issues/mental-health-america-printed-reports. 5. Al-Rousan T, et al. Inside the nation’s largest mental health institution: a prevalence study in a state prison system. BMC Public Health. 2017;17:342. www.ncbi.nlm.nih.gov/pmc/articles/PMC5397789/ 6. Invega Sustenna Prescribing Information. December 2017. Available at www.accessdata.fda.gov/scripts/cder/daf/.