- The FDA needs authority to mandate postmarketing safety trials with specific results timetables and to conduct annual safety reviews for the first 3 years after a drug's approval and again at 7 years; Drug ads and labels must include a toll-free telephone number and an Internet address; Substantial penalties for drug ads that overstate efficacy or understate adverse effects; The FDA must be able to mandate changes to labels as new safey and efficacy info becomes available; Every new drug should have a pharmacovigilance plan at the time of approval, and Clinical trials of drugs must be registered in a public database.
What don't the editors insist upon? Mandatory posting of clinical trial results. Oddly, they say nothing about medical devices, despite the recent brouhaha over drug-coated stents, a topic the NEJM pursued in its own pages. And there's no mention of conflicts of interest among FDA advisory committee members, a hot-button issue that even the House bill addresses.
So to the editors - Greg Curfman, Steve Morrissey and Jeff Drazen - we want to know: why don't these topics rate?