Congress ’ Remedy for Post-marketing Woes Might Not Be a Cure PDUFA Bill Gives the FDA New Resources—But Are They Enough?

post-marketing studies on time; they also cite the FDA’s lack of authority to compel timely completion. Serious limitations also afflict the FDA’s MedWatch system, which catalogues reports of adverse drug events (ADEs). More-over, even when troublesome signs appear after a drug is on the market, that evidence might not be available to the FDA’s Office of Surveillance and Epidemiology (OSE), formerly known as the Office of Drug Safety (ODS). The OSE is set up to ensure that post-marketing prob-lems receive quick attention. It is subservient to the FDA’s Office of New Drugs (OND), which has considerably more stature within the Center for Drug Evaluation and Research (CDER) and which has sometimes been criticized for turning a blind eye to emerging evidence of late-blooming safet