We’ve been sad lately. Once again, without explanation, our invitation to a presidential inauguration has been lost in the U.S. mail. We know that when the tears stop, as they eventually must, the emotional corner will have been turned. It’s not that Barack Obama is merely charisma—or some sort of electoral fluke. No. He’s a genuine visionary.…more...

As many readers know, the Supreme Court is considering the case of a Vermont musician, Diana Levine, who lost an arm when a physician assistant didn’t fully consider the label on a Wyeth anti-nausea drug. The legal debate is stark: can the FDA’s approval take precedence, or “preempt,” state courts hearing liability cases? Earlier this year, we…more...

Sydney “Syd” Wolfe, director of Public Citizen’s health research group, is scratching his head. Tequin (gatifloxacin)—an antibiotic that Public Citizen had campaigned against—was pulled from the market by its manufacturer, Bristol-Meyers Squibb (BMS). But BMS said that was because of lagging sales. That was two years ago. In September of this year, the FDA formally announced that…more...

A while back, we checked in with someone who makes a living suing the pharmaceutical industry. This week, we worked the other side of the street, chatting with Mark Mansour of Bryan Cave, where he runs the FDA practice group in the firm’s Washington, D.C. office. Mansour has been perplexed, he reports, at the non-approvable letter that…more...