Phenylephrine injection may yet become legitimate

Abstract

As FDA this year reviewed a new drug application for phenylephrine hydrochloride injection, agency personnel were in a quandary. Should the agency approve a decadesold substance that has a pharmacologic effect but for which there is no firm evidence of a clinical benefit? A group of advisers on September 13 said yes, but only for a narrow indication: neuraxial perioperative hypotension. The advisers mostly said no—the vote was 2 against 8—regarding the proposed broad indication of “acute hypotensive states such as shock.” If agency personnel agree with those advisers, then phenylephrine hydrochloride injection, an acknowledged vasopressor, will at last have FDA-approved labeling. FDA's decision is expected by November 9, the nine-month review deadline under the Prescription Drug User Fee Act. West-Ward Pharmaceutical Corp. admittedly based its new drug application on previously published literature and data the company does not own. FDA, according to an internal review of the application, told West-Ward in advance that the literature lacked sufficient evidence of phenylephrine's effectiveness. The studies underlying the literature did not seem adequately designed to show that a clinical outcome improved as a result of phenylephrine treatment, the reviewer wrote.