The Op-Ed: Off-Label Pregnancy Rx Needs More Regs

With all the talk of off-label promotion and commercial free speech, a vexing issue remains – patient safety. A case in point is the use of dexamethasone, which is sometimes given to pregnant women at risk of having a child with congenital adrenal hyperplasia. Prenatal dexamethasone cannot prevent a child being born with CAH, but it may reduce the odds a girl will be born sex atypical from having CAH. A recent paper in AJOG argued against the use because of safety concerns. We asked Alice Dreger, a professor of Clinical Medical Humanities & Bioethics at Northwestern University, to explain… In a legal case Pharmalot has been closely tracking, the FDA has “decided not to pursue a re-hearing before a federal appeals court that [in December] ruled the federal government could not prosecute a sales rep who promoted off-label uses because his speech was not false and misleading” (read more here). Hopefully Arnie Friede — a former FDA associate chief counsel — is right when he predicted in an op-ed for Pharmalot that “a slew of off-label promotion is unlikely” to follow this ruling. It’s worth noting that, within medical ethics, scholars have been arguing that off-label promotion should be more limited, not less; for example, writing in the Journal of Law and Medical Ethics, Rebecca Dresser and Joel Frader have called for “heightened professional and government oversight” in order to protect patients (look here). My own research into the use of de...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Alice Dreger Dexamethasone Medical Ethics Off Label Promotion Source Type: blogs