Contractor for clinician-focused addiction recovery program sued over ‘punishingly expensive’ practices

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance designed to help applicants add clinically relevant information about QTc interval prolongation to the labeling of non-antiarrhythmic drugs

The plaintiffs, 10 nurses and one doctor, are all enrolled in the state-mandated initiative for clinicians with past substance abuse issues. The rules require monitoring and regular drug testing to prove sobriety; however, the lot argues that the contractor in charge, Maximus, is being dishonestly punitive.