New psychiatric drugs continue to skate through the FDA’s approval process. Although these drugs enrich the bottom line of the pharmaceutical industry, new research finds that they lack clinical utility and represent a lack of innovation in the field.
According to a new study in the Journal of Clinical Psychiatry, there were 22 FDA approvals for psychiatric drugs between 2012 and 2024. The researchers—led by John Havlik at Stanford University and Sayana Isaac at the University of Chicago—investigated clinical utility, innovation, and other measures of helpfulness as rated by various international organizations and regulatory bodies.
“Innovation in psychiatric drug development in the past 13 years was limited, with most new drugs representing incremental advances rather than groundbreaking innovations. Compared to other medical fields, psychiatric drug development appears to lag in terms of novelty and clinical impact,” the researchers write.
Perhaps the most important measure is clinical utility—do the drugs actually help people? This is rated by French organization Prescrire. But none of the new drugs met their criteria for being clinically helpful. Of the 22 drug approvals, three were rated as “clinically not useful,” while the rest were rated as “judgment reserved,” meaning that there was insufficient data or the data was of such poor quality that it was not possible to assess efficacy.
Why does psychiatry struggle so much to create clinically useful new drugs? One answer, according to the researchers, is that most psychiatric drugs fail in early trials, probably because we don’t know much about the supposed biology of “mental illness.”
“The comparative absence of clear biomarkers in psychiatry (for target selection, prognostication, etc) plays a role, effectively limiting our understanding of why early-phase findings often fail to engender desired outcomes in later-phase trials. Without many clear-cut targets, it follows that the mechanisms of action of approved drugs and supplemental indications are often not as clear in psychiatry compared to other specialties,” the researchers write.
And according to the researchers, most of the “new” drugs are “me-too” drugs—tweaking an existing formula to create a slightly different drug of the same class, which usually means it has similar efficacy and side effects to existing drugs. Why would clinicians turn to these new, more expensive drugs, when there are cheaper generic versions of very similar drugs?
“It is challenging for another “me-too” addition-to-class drug to succeed in a market landscape where cheaper and similarly effective alternatives are already available,” the researchers write.
An “Orphan Drug” That Made $7 Billion a Year
There were two exceptions to the lack of efficacy and innovation, according to one organization: The French National Institute of Health ranked aripiprazole for Tourette’s and lurasidone for bipolar disorder as “having a high added therapeutic benefit.” Yet both of these drugs were originally approved before the time period of this study—meaning that the “added benefit” was actually just expanding existing drug approvals, not adding something new.
Lurasidone (marketed as Latuda) is an antipsychotic approved by the FDA for schizophrenia in 2010. But in 2013 that approval was expanded to treat “depressive episodes in bipolar disorder.” In 2017 and 2018, these approvals were expanded to children, as well. Interestingly, it has not been approved to treat psychotic episodes in bipolar disorder, despite being marketed as an antipsychotic drug and approved to treat schizophrenia.
Aripiprazole (marketed as Abilify), is an antipsychotic approved by the FDA for schizophrenia in 2002, bipolar disorder in 2004, and depression in 2007. However, the Tourette’s approval didn’t happen until 2014.
Abilify for Tourette’s was classed as an “orphan drug” by the FDA. The orphan drug status provides a slew of benefits to encourage pharmaceutical companies to spend money developing expensive drugs that treat rare disorders. To be an “orphan drug,” the medicine should be newly created to serve this unmet need. The FDA provides grants, tax credits, and a seven-year marketing exclusivity contract to ensure the drug can’t be undercut by generic versions—all on the assumption that drug makers wouldn’t otherwise waste the resources developing a drug that won’t turn a profit.
Yet Abilify doesn’t meet those criteria. Created by Otsuka and marketed by Bristol-Meyers Squibb, Abilify made those companies about $7 billion a year in profits. And BMS was caught breaking the law to pump those profits even higher—in 2007, they had to pay $515 million after illegally marketing the drug to children and to elderly patients with dementia, who are at an increased risk of death when using the drug.
Unfortunately for BMS, their patent expired in 2014 and generic forms of the drug became available. There’s one solution for drug companies when this happens: find a new indication for using the drug, a new disease for which the drug seems to work. Tourette’s provided BMS exactly that, right as their patent expired, and in 2014 they were able to get that coveted seven-year marketing contract by calling their most profitable drug an “orphan drug.”
Only a single psychiatric drug approval between 2012 and 2024 made it onto the World Health Organization’s Model List of Essential Medicines. That drug was aripiprazole for Tourette’s.
****
Havlik, J., Isaac, S., Radovan, C., Ostacher, M. J., Smith, D., & Rhee, T. G. (2026). Innovation in psychiatric drug development: A quantitative analysis of FDA-approved psychiatric drugs, 2012–2024. J Clin Psychiatry, 87(1), 25m16063. (Link)
The post None of the 22 FDA Approvals for Psychiatric Drugs in the Last Decade Were “Clinically Useful” appeared first on Mad In America.
IPAK-EDU is grateful to Mad In America as this piece was originally published there and is included in this news feed with mutual agreement. Read More
Leave a Reply