The Off-Label Loophole in the Psychopharmacologic Setting: Prescription of Antipsychotic Drugs in the Nonpsychotic Patient Population

U.S. physicians have wide discretion in treating patients with off-label medications. Many consider off-label prescription essential in our country’s health care system, and it is wholly supported by FDA and federal courts. Assumptions about physicians’ expertise, judgments, and commitments to beneficence and nonmaleficence undergird laissez-faire policies that allow and support physicians’ novel and innovate uses of FDA-approved drugs for purposes and populations not studied in original, strictly regulated clinical trials. Though sometimes beneficial, off-label prescribing, which flourishes in privatepractice psychiatry, often harms scores of psychiatric patients.

Frequently, potential harms are insufficiently disclosed to patients. In the public health sector, officials have begun to identify and warn of dangers surrounding antipsychotic use in nonpsychotic foster children. Within the government-funded insurance apparatus there are built-in means for checking harmful physician practices. Such oversight mechanisms are deficient in the private insurance sector, and absent where treatment is paid for out-of-pocket.

The Article proposes that private-practice psychiatrists’ collective widespread “experimental” treatment of nonpsychotic patients with antipsychotics off label resembles clinical research without regulation or meaningful accountability. Because harmful physician practices in the off-label antipsychotics space are largely unchecked by state regulation and law, action is required to protect some of our most vulnerable patients.